--- title: "MDR vs Product Liability Directive evidence comparison" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/mdr-vs-product-liability-directive" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/mdr-vs-product-liability-directive" author: "Sorena AI" description: "Compare EU MDR market-access evidence with Product Liability Directive exposure without treating compliance records as a liability outcome." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU MDR" - "Product Liability Directive" - "medical device evidence" - "technical documentation" - "PMS" - "vigilance" - "defect investigation" - "EU Medical Device Regulation" - "Regulation (EU) 2017/745" - "MDR vs Product Liability Directive" - "EU MDR compliance" - "EU MDR evidence" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # MDR vs Product Liability Directive evidence comparison Compare EU MDR market-access evidence with Product Liability Directive exposure without treating compliance records as a liability outcome. *Side-by-side* *EU* ## MDR vs Product Liability Directive Evidence comparison The MDR is a market-access and lifecycle compliance regime for medical devices: qualification, classification, conformity assessment, technical documentation, clinical evidence, PMS, vigilance, UDI, and EUDAMED records. The Product Liability Directive comparison is narrower here: MDR evidence can inform defect, damage, and causal-link investigations, but this page does not claim that MDR compliance decides civil liability. Use this comparison when the same medical-device facts must be handled in two different files: an MDR compliance file for placing and keeping a device on the EU market, and a liability-risk file that tests whether a defect, damage, and causal link may be alleged. Keep the records connected, but do not collapse the two legal questions into one conclusion. ## MDR vs Product Liability Directive: evidence comparison A grounded comparison for medical-device teams that need to keep MDR market-access compliance evidence separate from Product Liability Directive exposure analysis. - **MDR**: MDR controls market access and lifecycle compliance for medical devices through scope, roles, classification, conformity assessment, technical documentation, clinical evidence, PMS, vigilance, UDI, EUDAMED, and financial-coverage duties. - **Product Liability Directive**: The liability side is an exposure and investigation workstream. Grounded here, it focuses on defect, damage, causal relationship, and the MDR provisions that require liability coverage or can identify responsible actors. | Dimension | MDR | Product Liability Directive | Operational implication | Sources | | --- | --- | --- | --- | --- | | Scope boundary | MDR is a pre-market and post-market compliance regime for devices placed on, made available on, or put into service in the EU. | Product liability analysis asks whether a defective product caused compensable damage; it is not the route for CE marking or market placement. | Run MDR readiness and liability-risk review as linked but separate workstreams, with separate conclusions and source tags. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records.
[European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements.
[European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | | Covered actors | MDR records should identify the manufacturer, authorised representative, importer, distributor, PRRC, notified body where applicable, and the owner of each compliance artifact. | The liability file should identify parties tied to the alleged defect and harm; MDR grounding also flags manufacturer financial coverage and authorised-representative liability where the non-EU manufacturer has not met Article 10 obligations. | Do not let the regulatory-affairs owner silently absorb legal, insurance, supplier, customer, or litigation-response ownership. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | | Trigger | MDR work starts with intended purpose, medical-device qualification, classification, role, conformity route, market placement, and lifecycle changes. | Liability review starts from an allegation or scenario involving defect, damage, and causal relationship, including complaints, incidents, field actions, or injured-person claims. | Use intake questions that route a matter to MDR compliance, liability-risk review, or both; the same complaint may need two files. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | | Core obligations | MDR technical documentation supports conformity by documenting the device description, design, manufacture, GSPR evidence, benefit-risk rationale, verification, validation, clinical evidence, PMS plan, and updates. | The liability file can use the same documentation to reconstruct design choices, known risks, warnings, testing, changes, and what evidence existed at relevant points in time. | Keep version history and change-control links intact; a liability investigation often depends on the exact record that existed when the device was supplied or used. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | | Evidence record | MDR evidence includes classification rationale, conformity assessment route, certificates, declarations, Annex II and III technical documentation, clinical evaluation, PMS or PMCF, vigilance, UDI, EUDAMED, IFU, and labelling records. | Liability-risk evidence should assemble alleged defect facts, harm facts, causal-link facts, product history, warnings, IFU versions, PMS findings, complaints, field actions, and technical-change records. | Reuse MDR evidence as an indexed fact base, but mark which documents support MDR compliance and which are being used only as investigation evidence. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records.
[European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | | Timing and deadlines | MDR requires post-market surveillance and vigilance processes that document complaints, incidents, serious-incident reportability, field safety corrective actions, PMCF outputs, and risk updates. | Those records can show notice, trend signals, corrective action history, and follow-up facts relevant to defect and causation questions, without deciding the liability result. | Route every complaint or incident through MDR reportability and through the separate liability evidence map when harm or defect allegations are present. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | | Enforcement | The MDR output is a market-access or lifecycle decision: proceed, remediate, escalate to notified body or competent authority, update documentation, report, or stop supply. | The liability output is an investigation and exposure view: what is alleged, what evidence exists, what gaps remain, who owns follow-up, and what legal or insurance review is needed. | Keep wording precise: MDR compliance evidence may support the investigation, but the page should not state that compliance guarantees a liability defence or that non-compliance proves liability. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records.
[European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements.
[European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | | Overlap and reuse | MDR compliance may rely on harmonised standards or other technical solutions to demonstrate requirements, with OJEU-referenced standards supporting presumption-of-conformity analysis where applicable. | For liability review, standards evidence can help explain the technical baseline considered, but the Product Liability Directive question still turns on defect, damage, and causal relationship. | Do not convert a standards matrix into a liability conclusion; keep it as evidence for what design and verification baseline was used. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | | Practical decision rule | MDR is a pre-market and post-market compliance regime for devices placed on, made available on, or put into service in the EU. | Product liability analysis asks whether a defective product caused compensable damage; it is not the route for CE marking or market placement. | Run MDR readiness and liability-risk review as linked but separate workstreams, with separate conclusions and source tags. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions.
[MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records.
[European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements.
[European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records.
[Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. | Sources for Scope boundary - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records. - Quote: "The Basic UDI-DI is the main key in the database" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. - Quote: "The use of these standards remains voluntary." - [European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records. - Quote: "EUDAMED is the IT system developed by the European Commission" Sources for Scope boundary - Product Liability Directive: - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Scope boundary - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Covered actors - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records. - Quote: "EUDAMED is the IT system developed by the European Commission" Sources for Covered actors - Product Liability Directive: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Covered actors - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Trigger - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" Sources for Trigger - Product Liability Directive: - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Trigger - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Core obligations - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. - Quote: "The use of these standards remains voluntary." Sources for Core obligations - Product Liability Directive: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Core obligations - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Evidence record - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records. - Quote: "The Basic UDI-DI is the main key in the database" - [European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records. - Quote: "EUDAMED is the IT system developed by the European Commission" Sources for Evidence record - Product Liability Directive: - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" Sources for Evidence record - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records. - Quote: "The Basic UDI-DI is the main key in the database" Sources for Timing and deadlines - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records. - Quote: "EUDAMED is the IT system developed by the European Commission" Sources for Timing and deadlines - Product Liability Directive: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Timing and deadlines - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Enforcement - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records. - Quote: "The Basic UDI-DI is the main key in the database" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. - Quote: "The use of these standards remains voluntary." - [European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records. - Quote: "EUDAMED is the IT system developed by the European Commission" Sources for Enforcement - Product Liability Directive: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Enforcement - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Overlap and reuse - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. - Quote: "The use of these standards remains voluntary." Sources for Overlap and reuse - Product Liability Directive: - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. - Quote: "The use of these standards remains voluntary." Sources for Overlap and reuse - operational implication: - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. - Quote: "The use of these standards remains voluntary." Sources for Practical decision rule - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records. - Quote: "The Basic UDI-DI is the main key in the database" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. - Quote: "The use of these standards remains voluntary." - [European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records. - Quote: "EUDAMED is the IT system developed by the European Commission" Sources for Practical decision rule - Product Liability Directive: - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" Sources for Practical decision rule - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" ### How should teams use this comparison? - Start with an MDR fact sheet: device, intended purpose, risk class, role, conformity route, certificate or declaration status, UDI identifiers, technical documentation version, PMS owner, and vigilance status. - Open a liability-risk file only for grounded exposure questions: alleged defect, alleged damage, causal-link facts, responsible actors, and the MDR records that can support or challenge those facts. - Escalate legal conclusions separately; the operational record should say what evidence exists and what remains unresolved, not decide civil liability outcomes. Sources for the practical decision rule: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" ## Separate the MDR compliance file from the liability-risk file The MDR side asks whether the product is a medical device or accessory, which role the company plays, which classification and conformity route applies, and which technical, clinical, PMS, vigilance, UDI, and EUDAMED records must exist before and after market placement. The Product Liability Directive side is not a market-access checklist. Based on the MDR grounding available here, keep it to the grounded product-liability frame: a defective product claim turns on defect, damage, and a causal relationship, while MDR and national-law liability provisions may affect who must be in the investigation file. - Create one MDR index for classification, conformity assessment, technical documentation, clinical evaluation, PMS or PMCF, vigilance decisions, UDI data, EUDAMED submissions, certificates, declarations, IFU, labelling, and field actions. - Create a separate liability-risk index for complaint facts, alleged harm, device history, design or manufacturing changes, warnings and IFU versions, PMS findings, vigilance assessments, corrective actions, and causation questions. - Use MDR evidence to reconstruct what was known, controlled, monitored, and communicated; do not state that the MDR file proves or disproves liability without a separate legal assessment. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. ## Use MDR evidence to support investigations without overclaiming it MDR evidence is useful because it is structured around the device lifecycle. Technical documentation and clinical evidence show the intended purpose, design choices, benefit-risk rationale, standards or common specifications used, and the data behind safety and performance claims. Post-market records add what happened after release: complaints, non-serious incidents kept in the QMS, serious-incident reportability decisions, field safety corrective actions, PMCF outputs, trend signals, and updates to risk management or clinical evaluation. Those records can support a defect investigation, but they remain evidence inputs rather than automatic liability conclusions. - Tie each complaint or incident to device identifiers, Basic UDI-DI or UDI-DI where relevant, batch or serial data, IFU and labelling version, software version, certificate scope, and market where the event occurred. - Link the investigation file to the MDR source record that supports the fact: technical documentation, clinical evaluation report, PMS plan, PMCF plan or report, vigilance assessment, field safety notice, EUDAMED entry, or harmonised-standard rationale. - Record unresolved issues separately, such as missing samples, incomplete use conditions, uncertain causation, supplier gaps, or whether a changed device still matches the certified configuration. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records. - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. *Recommended next step* *Placement: after implementation section* ## Review MDR evidence before liability-risk discussions Build a cited evidence map that separates MDR compliance records from defect, damage, and causation questions, then reuse the map for investigations, authority responses, and customer assurance. - [Open Research Copilot](/solutions/research-copilot.md): Trace MDR obligations and evidence records back to cited sources. - [Talk through evidence mapping](/contact.md): Review technical documentation, PMS, vigilance, and investigation evidence without overclaiming liability outcomes. ## Review triggers for the combined evidence map Reopen the comparison when the MDR evidence baseline changes or when a new liability allegation depends on facts not already covered by the technical and PMS file. The useful output is an evidence map, not a merged legal opinion. - Product change: new intended purpose, claims, software logic, materials, supplier, manufacturing process, accessories, packaging, or IFU wording. - Market-access change: classification or conformity route change, notified-body question, certificate scope issue, harmonised-standard update, UDI change, EUDAMED module dependency, or legacy-device transition condition. - Post-market signal: complaint cluster, serious-incident assessment, field safety corrective action, PMCF finding, trend report, corrective and preventive action, or customer allegation involving defect, damage, or causation. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - [European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records. ## Primary sources - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for market placement, conformity assessment, technical documentation, PMS, vigilance, UDI, EUDAMED, financial coverage, and authorised-representative liability provisions. - Quote: "placing on the market, making available on the market or putting into service" - [Commission Notice - Blue Guide on EU product rules (2022)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A52022XC0629%2804%29&ref=sorena.io) - Commission product-law guidance used for the grounded Product Liability Directive comparison, including strict liability, defect, damage, and causal-link framing. - Quote: "the damage, the defect and the causal relationship" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG guidance used for Basic UDI-DI, UDI traceability, and links between UDI data, technical documentation, certificates, declarations, and SSCP records. - Quote: "The Basic UDI-DI is the main key in the database" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for voluntary harmonised standards, OJEU references, and their role in demonstrating compliance with EU legal requirements. - Quote: "The use of these standards remains voluntary." - [European Commission - EUDAMED overview](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Commission source for EUDAMED as the IT system implementing MDR and IVDR modules, including actor, UDI/device, certificates, and vigilance-related records. - Quote: "EUDAMED is the IT system developed by the European Commission" ## Related Topic Guides - [Custom-made medical devices under the EU MDR | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md): Concise EU MDR FAQ on custom-made device definition, mass-produced exclusions, Annex XIII statements, documentation, conformity assessment, PMS, vigilance, and records to retain. - [EU MDR Annex II and III Technical Documentation](/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents.md): Build an MDR technical documentation index for Annex II device files and Annex III post-market surveillance evidence, including GSPR, risk, clinical, PMS, UDI, and EUDAMED records. - [EU MDR Annex VIII Classification Guide](/artifacts/eu/medical-device-regulation/annex-viii-classification.md): Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact. - [EU MDR Annex XVI products without a medical purpose](/artifacts/eu/medical-device-regulation/annex-xvi-products.md): source-linked EU MDR guide for Annex XVI products: listed product groups, common specifications, clinical evidence, notified-body route, UDI, EUDAMED, PMS, and vigilance evidence before launch. - [EU MDR Applicability Test](/artifacts/eu/medical-device-regulation/applicability-test.md): Test whether a product, accessory, software function, or Annex XVI product falls under the EU Medical Device Regulation, and record the evidence for the next classification step. - [EU MDR change assessment workflow](/artifacts/eu/medical-device-regulation/change-assessment-workflow.md): Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change. - [EU MDR Checklist for Medical Device Compliance](/artifacts/eu/medical-device-regulation/checklist.md): Practical EU MDR checklist covering qualification, classification, conformity assessment, technical documentation, GSPR, clinical evidence, UDI, EUDAMED, PMS, vigilance, QMS, and legacy transition evidence. - [EU MDR classification workflow](/artifacts/eu/medical-device-regulation/classification-workflow.md): A concrete EU MDR classification workflow for intended purpose, device or accessory qualification, Annex VIII rule selection, Rule 11 software review, class outcome, and notified body impact. - [EU MDR Clinical Evaluation Overview](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): EU MDR clinical evaluation overview covering Article 61, Annex XIV, clinical data sources, equivalence, PMCF, CER evidence, notified body review, GSPR, and benefit-risk support. - [EU MDR Clinical Evaluation Report Template](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A source-linked EU MDR clinical evaluation report template covering intended purpose, GSPR linkage, clinical data appraisal, equivalence limits, PMCF, conclusions, and reviewer signoff. - [EU MDR clinical evidence guide](/artifacts/eu/medical-device-regulation/clinical-evidence.md): source-linked EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review. - [EU MDR compliance obligations](/artifacts/eu/medical-device-regulation/compliance.md): EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls. - [EU MDR conformity route workflow](/artifacts/eu/medical-device-regulation/conformity-route-workflow.md): source-linked EU MDR workflow for classifying a device, choosing the conformity assessment route, preparing technical and QMS evidence, and reaching certificate, DoC, UDI, EUDAMED, and CE outputs. - [EU MDR deadlines and compliance calendar](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): Grounded EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews. - [EU MDR Device Classification Guide](/artifacts/eu/medical-device-regulation/device-classification-guide.md): Classify an EU MDR medical device by intended purpose, Annex VIII duration, invasiveness, active-device and software rules, then document the conformity route impact. - [EU MDR EUDAMED and UDI registration](/artifacts/eu/medical-device-regulation/eudamed-and-udi.md): source-linked MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance. - [EU MDR FAQ: qualification, evidence, UDI, and transition](/artifacts/eu/medical-device-regulation/faq.md): Concise EU MDR FAQ covering device qualification, software classification, accessories, custom-made devices, clinical evidence, UDI, EUDAMED, notified bodies, significant changes, and legacy transition. - [EU MDR Legacy Device Transition](/artifacts/eu/medical-device-regulation/legacy-device-transition.md): source-linked EU MDR legacy device transition guide covering Regulation (EU) 2023/607 conditions, certificate validity, significant-change limits, surveillance, PMS, vigilance, QMS, and evidence records. - [EU MDR notified body route selection](/artifacts/eu/medical-device-regulation/notified-body-route-selection.md): Choose an EU MDR conformity assessment route by device class, Article 52 option, notified body designation scope, QMS readiness, technical documentation, clinical evidence, and certificate evidence. - [EU MDR penalties and enforcement risk](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): source-linked EU MDR penalties and enforcement-risk guide covering Article 113, Member State penalty rules, market restrictions, recalls, certificate consequences, and evidence. - [EU MDR PMS and Vigilance Guide](/artifacts/eu/medical-device-regulation/pms-and-vigilance.md): EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records. - [EU MDR PMS and vigilance records](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): source-linked EU MDR guide to PMS plans, PMS reports, PSURs, PMCF updates, serious incident and FSCA reporting, trend reporting, and EUDAMED evidence handling. - [EU MDR PMS Plan Template for Medical Devices](/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template.md): A source-linked EU MDR post-market surveillance plan template covering device scope, PMS data sources, PMCF linkage, vigilance, trend reporting, PMSR or PSUR outputs, roles, cadence, and evidence records. - [EU MDR QMS and technical file evidence map](/artifacts/eu/medical-device-regulation/qms-and-technical-file.md): Map EU MDR Article 10 QMS duties to Annex II and Annex III technical documentation, PMS, vigilance, UDI records, and notified-body review evidence. - [EU MDR QMS requirements under Article 10](/artifacts/eu/medical-device-regulation/qms.md): EU MDR QMS guide for Article 10 manufacturer controls covering regulatory strategy, design, risk, clinical evaluation, PMS, vigilance, UDI, suppliers, CAPA, and conformity records. - [EU MDR qualification and borderline products](/artifacts/eu/medical-device-regulation/qualification-and-borderline-products.md): EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment. - [EU MDR qualification workflow](/artifacts/eu/medical-device-regulation/qualification-workflow.md): A concrete EU MDR workflow for deciding whether a product is a medical device, accessory, Annex XVI product, IVD interface, medicinal-product interface, or non-MDR product before classification and conformity assessment. - [EU MDR requirements checklist](/artifacts/eu/medical-device-regulation/requirements.md): Concrete EU MDR requirements for medical-device scope, classification, GSPR, conformity assessment, technical documentation, QMS, clinical evidence, UDI, EUDAMED, PMS, vigilance, and economic-operator records. - [EU MDR Rule 11 software classification](/artifacts/eu/medical-device-regulation/rule-11-software.md): Classify MDR medical device software under Rule 11 using intended purpose, diagnosis or therapy decision impact, physiological monitoring, conformity route, clinical evidence, and software-change records. - [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md): FAQ on MDR significant changes for legacy devices, including intended-purpose, design, software, material, sterilisation, clinical, QMS, notified-body, and evidence impacts. - [EU MDR Transition Timelines: practical guide](/artifacts/eu/medical-device-regulation/transition-timelines.md): EU Medical Device Regulation guide to Transition Timelines with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps. - [EU MDR UDI and EUDAMED registration guide](/artifacts/eu/medical-device-regulation/udi-and-eudamed.md): EU MDR guide to Basic UDI-DI, UDI-DI, UDI carriers, EUDAMED actor and device registration, change impacts, and evidence governance. - [EU MDR vigilance reporting workflow](/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow.md): Concrete EU MDR vigilance workflow for incident intake, serious incident assessment, FSCA and FSN handling, trend reporting, EUDAMED caveats, CAPA, PMS, clinical evaluation updates, and records. - [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md): EU MDR FAQ explaining what Basic UDI-DI and UDI-DI identify, how they connect to UDI carriers, EUDAMED records, change triggers, and retained evidence. - [MDR vs AI Act for medical-device software](/artifacts/eu/medical-device-regulation/mdr-vs-ai-act.md): Compare MDR software qualification, classification, clinical evidence, QMS, PMS, UDI, EUDAMED, and notified-body evidence boundaries against cautiously scoped AI Act overlap. - [MDR vs GPSR: medical-device boundary checks](/artifacts/eu/medical-device-regulation/mdr-vs-gpsr.md): Compare MDR medical-device scope with general product-safety fallback questions for borderline, non-medical, and Annex XVI products. - [MDR vs IVDR: medical devices and IVDs compared](/artifacts/eu/medical-device-regulation/mdr-vs-ivdr.md): Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance. - [What should an EU MDR PMCF plan and report cover? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/pmcf.md): Under the EU MDR, PMCF is part of PMS and clinical evaluation. See what the plan, activities, report, updates, and retained evidence should cover. - [What should manufacturers do when an EU MDR classification changes? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/class-changes.md): Concise EU MDR FAQ on classification changes, intended purpose, software, notified-body route impact, certificates, technical documentation, and retained evidence. - [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md): EU MDR FAQ on clinical equivalence, including technical, biological, and clinical characteristics, access to equivalent-device data, class III and implantable-device limits, clinical evaluation, PMCF, and retained evidence. - [When do software or products make medical purpose claims under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/medical-purpose-claims.md): EU MDR FAQ on medical purpose claims, intended purpose evidence, software qualification, Annex XVI contrasts, and records to keep. - [When is a PSUR required under the EU MDR and what should it contain? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/psur.md): EU MDR FAQ on PSUR scope, content, update cadence, PMS and PMCF links, notified-body handling, EUDAMED submission, and evidence to retain. - [When is an accessory regulated under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/accessories.md): EU MDR FAQ on when an article is a medical device accessory, how intended purpose affects classification, and what evidence to keep. - [When is software regulated as SaMD under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/software-and-samd.md): Concise EU MDR FAQ on software qualification, intended medical purpose, Rule 11 classification, modules, clinical evidence, change assessment, UDI, and EUDAMED. - [Which devices need an SSCP under the EU MDR and what should it include? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/sscp.md): EU MDR FAQ on when an SSCP is required, who prepares, validates, uploads, and updates it, and what evidence should support the summary. - [Which EUDAMED modules matter under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/eudamed-modules.md): EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records. --- [Privacy Policy](https://www.sorena.io/privacy) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). 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