--- title: "EU RoHS for medical devices and monitoring equipment" canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/medical-devices-and-monitoring-equipment" source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/medical-devices-and-monitoring-equipment" author: "Sorena AI" description: "RoHS category 8 and 9 guide covering application dates, Annex IV exemptions, phthalates, spare parts, CE marking, declarations, and technical documentation." published_at: "2026-05-09" updated_at: "2026-05-27" keywords: - "RoHS medical devices" - "RoHS category 8" - "RoHS category 9" - "monitoring and control instruments" - "Annex IV exemptions" - "EU RoHS phthalates" - "EU RoHS Directive" - "medical devices" --- **[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) --- # EU RoHS for medical devices and monitoring equipment RoHS category 8 and 9 guide covering application dates, Annex IV exemptions, phthalates, spare parts, CE marking, declarations, and technical documentation. *Artifact Guide* *EU* ## EU RoHS for medical and monitoring equipment Category 8 medical devices and category 9 monitoring and control instruments are inside RoHS, but their application dates, phthalate timing, spare-part rules, and Annex IV exemptions need separate tracking. Use this page to build a RoHS release record for medical devices, in vitro diagnostic devices, monitoring instruments, and industrial monitoring and control instruments. For medical devices and monitoring equipment, a useful RoHS decision is not just a pass/fail material statement. It should identify the category 8 or 9 subcategory, the placing-on-the-market date, the homogeneous-material restrictions, any Annex III or Annex IV exemption relied on, and the CE declaration and technical documentation that support the conclusion. ## Scope and application dates for categories 8 and 9 Directive 2011/65/EU lists category 8 as medical devices and category 9 as monitoring and control instruments, including industrial monitoring and control instruments. The restriction in Article 4(1) applies by subcategory date, so the first question is whether the product is a general medical device, an in vitro diagnostic medical device, a general monitoring or control instrument, or an industrial monitoring and control instrument. The core substance restrictions apply to medical devices and general monitoring and control instruments placed on the market from 22 July 2014, in vitro diagnostic medical devices from 22 July 2016, and industrial monitoring and control instruments from 22 July 2017. Products outside old RoHS scope but inside RoHS 2 had a separate open-scope date of 22 July 2019, unless a more specific category 8 or 9 date applied. - Classify the finished EEE against Annex I before reviewing exemptions or supplier evidence. - Record the exact placing-on-the-market date because Article 4 treats category 8, in vitro diagnostic devices, category 9, and industrial monitoring instruments differently. - Apply Annex II maximum concentration values at homogeneous-material level: 0.1% for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP, and 0.01% for cadmium. Sources for this answer: - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for Annex I categories, Article 4 application dates, and Annex II homogeneous-material concentration limits. - [Commission Delegated Directive (EU) 2015/863 adding phthalates to RoHS Annex II](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Binding source for DEHP, BBP, DBP, and DIBP limits and later application to medical and monitoring equipment. ## What changes for phthalates and spare parts The four phthalates added by Delegated Directive (EU) 2015/863 have their own timing for this equipment family. DEHP, BBP, DBP, and DIBP restrictions apply to medical devices, including in vitro medical devices, and to monitoring and control instruments, including industrial monitoring instruments, from 22 July 2021. Spare parts need a dated analysis rather than a blanket exemption. Annex II excludes the four phthalate restrictions for cables and spare parts used for repair, reuse, updating, or capacity upgrading of medical devices and monitoring and control instruments placed on the market before 22 July 2021. Article 4 also contains older category-specific spare-part provisions for the six original RoHS substances and reused parts in auditable closed-loop business-to-business systems. - Separate the original six restricted substances from the four phthalates because the legal dates and spare-part wording differ. - For service parts, record the original equipment category, original placing-on-market date, part source, reuse or repair purpose, and whether the part is a finished EEE or only a spare part. - Do not describe a spare-part route as generally available unless the date, category, substance, and use condition all match the directive text. Sources for this answer: - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for Article 4 cable, spare-part, reused-part, and closed-loop provisions. - [Commission Delegated Directive (EU) 2015/863 adding phthalates to RoHS Annex II](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Binding source for the phthalate transition rule for medical devices and monitoring and control instruments. ## Use Annex IV carefully, not as a product-wide waiver Medical and monitoring equipment may use ordinary Annex III exemptions where the entry applies, and may also use Annex IV entries that are specific to medical devices and monitoring and control instruments. Those entries are application-specific, not company-wide or product-wide. A compliant record should therefore identify the exact material or component, restricted substance, exemption entry, category, expiry date, and renewal status. The current consolidated directive includes Annex IV entries for applications such as ionising-radiation detectors, X-ray tubes, MRI-related uses, electrochemical sensors, industrial monitoring sensors, recovered spare parts, and certain DEHP uses. Several entries have expired dates, while others show future expiry dates such as 30 June 2026, 31 December 2025, 31 March 2027, 30 June 2027, and 21 July 2028, depending on the entry. Do not reuse those dates across entries. - Check Annex III first for general EEE exemptions and Annex IV for medical or monitoring-specific applications. - Treat every exemption as a narrow application statement tied to one substance, use, category, and expiry date. - Track renewal requests early: Article 5 requires renewal applications no later than 18 months before expiry, and the Commission says existing exemptions with a renewal request remain valid until it decides. Sources for this answer: - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for Article 5 exemption criteria, renewal timing, Annex III, and Annex IV entries. - [European Commission - RoHS Directive implementation](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/rohs-directive-implementation_en?ref=sorena.io) - Commission implementation page for exemption procedure, reassessment factors, and current timing expectations. ## Evidence package for release and market surveillance For category 8 and 9 products, the evidence file should let a reviewer trace the classification, date decision, restricted-substance assessment, exemptions, supplier inputs, and CE declaration without relying on project memory. Manufacturers must draw up technical documentation, complete the conformity assessment route, draw up the EU declaration of conformity, affix the CE marking on finished EEE, and keep the technical documentation and declaration for 10 years after placing the EEE on the market. EN IEC 63000:2018 is the harmonised standard reference published for RoHS technical documentation. It supports a structured evidence set for materials, components, and EEE; it does not supersede the need to map the specific device, instrument, spare part, supplier declaration, lab test, or exemption to the exact RoHS requirement. - Keep a dated category memo, BOM or material declaration set, restricted-substance matrix, exemption register, supplier declarations, test rationale, technical file, EU declaration of conformity, CE marking evidence, and change-control log. - Importers should verify that the manufacturer completed conformity assessment, drew up technical documentation, supplied CE marking and required documents, and kept required identification and contact information. - Reopen the record when design, materials, suppliers, service parts, intended use, harmonised standards, or Annex III and IV exemption status changes. Sources for this answer: - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for manufacturer, importer, distributor, CE marking, declaration, presumption of conformity, and retention duties. - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source publishing EN IEC 63000:2018 as the harmonised standard reference for RoHS technical documentation. *Recommended next step* *Placement: after implementation section* ## Build a RoHS category 8 or 9 evidence record Turn the category, date, substance, exemption, supplier, and CE evidence into one reviewable record for product, regulatory, quality, procurement, and service teams. - [Open Research Copilot](/solutions/research-copilot.md): Answer RoHS scope, exemption, and evidence questions with cited outputs. - [Talk through implementation](/contact.md): Review your category 8 or 9 scope, evidence model, supplier controls, and next actions. ## Primary sources - [Directive 2011/65/EU on restriction of hazardous substances (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for RoHS categories 8 and 9, Article 4 application dates, Article 5 exemptions, economic-operator duties, Annex II limits, Annex III, Annex IV, and the EU declaration model. - Quote: "Monitoring and control instruments" - [Commission Delegated Directive (EU) 2015/863 adding phthalates to RoHS Annex II](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Binding source for DEHP, BBP, DBP, and DIBP limits and the 22 July 2021 application date for medical devices and monitoring and control instruments. - Quote: "DEHP, BBP, DBP and DIBP" - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source for publication of EN IEC 63000:2018 as the harmonised standard reference for RoHS technical documentation. - Quote: "technical documentation required for assessing materials" - [European Commission - RoHS Directive implementation](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/rohs-directive-implementation_en?ref=sorena.io) - Commission implementation page for exemption procedure, renewal timing, reassessment factors, stakeholder consultations, and assessment studies. - Quote: "Exemptions are limited in time" ## Related Topic Guides - [Are cables in scope of EU RoHS? Cable evidence, CE marking, and DoC FAQ](/artifacts/eu/rohs-directive/faq/cables.md): EU RoHS cable FAQ covering when cables are EEE, how internal and external cables are treated, when separate CE marking and a DoC are needed, and what evidence to keep. - [Do Components Need EU RoHS Compliance? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/components.md): RoHS FAQ for components in electrical and electronic equipment: substance restrictions, homogeneous materials, CE marking, technical files, exemptions, and supplier evidence. - [EN IEC 63000 RoHS Technical Documentation](/artifacts/eu/rohs-directive/en-iec-63000-technical-documentation.md): source-linked guide to EN IEC 63000:2018 technical documentation for EU RoHS, including manufacturer duties, evidence records, harmonised-standard status, and file maintenance. - [EU RoHS Annex III and IV exemptions guide](/artifacts/eu/rohs-directive/annex-iii-and-iv-exemptions.md): How to use, renew, or challenge EU RoHS Annex III and Annex IV exemptions, with Article 5 criteria, timing rules, and evidence requirements. - [EU RoHS Applicability Test for EEE Scope](/artifacts/eu/rohs-directive/applicability-test.md): Decide whether EU RoHS applies to electrical and electronic equipment, cables, spare parts, exclusions, exemptions, CE marking, and evidence records. - [EU RoHS CE Marking and Declaration of Conformity](/artifacts/eu/rohs-directive/ce-and-doc.md): source-linked guide to RoHS CE marking, EU Declaration of Conformity, technical documentation, EN IEC 63000, and importer or distributor checks. - [EU RoHS compliance checklist for EEE](/artifacts/eu/rohs-directive/checklist.md): Checklist for EU RoHS scope, restricted substances, homogeneous materials, exemptions, CE marking, technical documentation, and supplier evidence. - [EU RoHS Compliance Guide for EEE](/artifacts/eu/rohs-directive/compliance.md): Practical EU RoHS compliance guide for electrical and electronic equipment: scope, restricted substances, exemptions, CE marking, technical documentation, and supplier evidence. - [EU RoHS Deadlines and Compliance Calendar](/artifacts/eu/rohs-directive/deadlines-and-compliance-calendar.md): source-linked RoHS calendar for scope phase-ins, phthalate dates, exemption renewals, spare-parts cutoffs, EN IEC 63000, CE files, and review triggers. - [EU RoHS Declarations vs Lab Tests FAQ](/artifacts/eu/rohs-directive/faq/declarations-vs-lab-tests.md): When supplier declarations can support EU RoHS technical documentation, when IEC 62321 lab testing is stronger evidence, and how to document the decision. - [EU RoHS Directive FAQ: scope, substances, CE marking](/artifacts/eu/rohs-directive/faq.md): Practical EU RoHS Directive FAQ covering EEE scope, Annex II substance limits, cables, spare parts, technical documentation, CE marking, and exemptions. - [EU RoHS EEE Categories and Open Scope](/artifacts/eu/rohs-directive/eee-categories-and-open-scope.md): Map products to EU RoHS EEE categories, category 11 open scope, Article 2 exclusions, cables, spare parts, and evidence needed for RoHS scope decisions. - [EU RoHS penalties and fines: Member State sanctions](/artifacts/eu/rohs-directive/penalties-and-fines.md): source-linked guide to EU RoHS penalty exposure: national sanctions, no EU-wide fine table, CE marking misuse, corrective actions, recalls, and evidence records. - [EU RoHS Phthalates: DEHP, BBP, DBP, DIBP](/artifacts/eu/rohs-directive/phthalates.md): source-linked RoHS guide to DEHP, BBP, DBP, and DIBP: 0.1% homogeneous-material limits, 2019 and 2021 application dates, exemptions, evidence, and testing standards. - [EU RoHS requirements for EEE, substances, and CE evidence](/artifacts/eu/rohs-directive/requirements.md): Practical EU RoHS requirements guide covering EEE scope, Annex II substance limits, exemptions, technical documentation, EU declaration of conformity, CE marking, and operator evidence. - [EU RoHS Restricted Substances and Thresholds | Annex II Limits](/artifacts/eu/rohs-directive/restricted-substances-and-thresholds.md): EU RoHS Annex II restricted substances and maximum concentration values by weight in homogeneous materials, including cadmium's 0.01% limit and the 0.1% limits for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. - [EU RoHS Spare Parts: Repair and Reuse](/artifacts/eu/rohs-directive/spare-parts.md): source-linked RoHS spare-parts guide covering Article 4 repair parts, reused recovered parts, closed-loop conditions, phthalate carve-outs, CE evidence, and cutoff dates. - [EU RoHS test plan selection workflow](/artifacts/eu/rohs-directive/test-plan-selection-workflow.md): Choose RoHS supplier evidence, EN IEC 63000 technical documentation, and IEC 62321 testing without over-testing or under-documenting restricted substances. - [How should RoHS lead, mercury, and cadmium exemptions be documented? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/lead-mercury-and-cadmium-exemptions.md): RoHS FAQ on documenting lead, mercury, and cadmium exemptions with Annex III or IV entries, material-level limits, expiry status, supplier evidence, and technical documentation. - [RoHS BOM evidence intake workflow](/artifacts/eu/rohs-directive/bom-evidence-intake-workflow.md): Build a RoHS BOM evidence intake process for EEE: map parts to homogeneous materials, collect supplier declarations, handle exemptions, and feed EN IEC 63000 technical documentation. - [RoHS exemption register workflow: expiry, renewal, evidence](/artifacts/eu/rohs-directive/exemption-register-workflow.md): Build a RoHS exemption register that tracks Annex III and IV entries, product scope, expiry dates, renewal status, evidence owners, and Commission source links. - [RoHS exemptions tracker guide: fields, evidence, gates](/artifacts/eu/rohs-directive/rohs-exemptions-tracker-guide.md): Build a RoHS exemptions tracker for Annex III and IV claims, renewal timing, supplier evidence, EN IEC 63000 documentation, and release decisions. - [RoHS Exemptions Tracking Register](/artifacts/eu/rohs-directive/exemptions-tracking.md): Track EU RoHS Annex III and IV exemptions by material, component, category, expiry date, renewal status, Article 5 rationale, and evidence record. - [RoHS Homogeneous Material Definition and Limits](/artifacts/eu/rohs-directive/faq/homogeneous-material.md): Plain-English EU RoHS FAQ on homogeneous materials, Annex II thresholds, coatings, cables, assemblies, and evidence needed for material-level RoHS decisions. - [RoHS Homogeneous Material Thresholds](/artifacts/eu/rohs-directive/homogeneous-material-thresholds.md): EU RoHS guide to homogeneous material thresholds: 0.1% limits, the 0.01% cadmium limit, material splitting, coatings, samples, exemptions, and technical evidence. - [RoHS importer checks for imported EEE before EU market placement](/artifacts/eu/rohs-directive/faq/imported-eee.md): Importer-focused RoHS FAQ covering CE marking, EU declaration of conformity, technical documentation availability, importer identity, nonconformity handling, and 10-year DoC retention. - [RoHS Risk-Based Testing Guide](/artifacts/eu/rohs-directive/risk-based-testing.md): source-linked EU RoHS guide to risk-based testing, EN IEC 63000 documentation, IEC 62321 methods, supplier evidence, and technical-file decisions. - [RoHS Supplier Change Control Workflow](/artifacts/eu/rohs-directive/supplier-change-control-workflow.md): source-linked EU RoHS supplier change control workflow for part substitutions, material changes, supplier declarations, testing decisions, and technical-file updates. - [RoHS Supplier Declaration Template](/artifacts/eu/rohs-directive/rohs-supplier-declaration-template.md): source-linked EU RoHS supplier declaration template guidance for collecting material evidence, exemption claims, test records, and EN IEC 63000 technical-file inputs. - [RoHS Supplier Declarations and Verification Guide](/artifacts/eu/rohs-directive/supplier-declarations-and-verification.md): Build a RoHS supplier evidence file without confusing supplier declarations with manufacturer EU DoC, CE marking, technical documentation, or importer checks. - [RoHS Supplier Declarations Guide](/artifacts/eu/rohs-directive/supplier-declarations.md): Use RoHS supplier declarations as supporting evidence for BOM, material, exemption, and technical-file reviews without replacing manufacturer EU DoC or CE duties. - [RoHS technical documentation, EU DoC and CE marking](/artifacts/eu/rohs-directive/technical-documentation-and-ce.md): source-linked guide to RoHS technical documentation, EN IEC 63000 evidence, EU declarations of conformity, CE marking, and manufacturer, importer and distributor duties. - [RoHS Timeline: practical guide](/artifacts/eu/rohs-directive/timeline.md): EU RoHS Directive guide to Timeline with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps. - [RoHS vs Batteries Regulation scope comparison](/artifacts/eu/rohs-directive/rohs-vs-batteries-regulation.md): RoHS-focused comparison explaining when RoHS applies to EEE, why batteries sit outside RoHS, and what evidence should not be reused without separate battery-law support. - [RoHS vs LVD/EMC CE evidence: what belongs in the RoHS file](/artifacts/eu/rohs-directive/rohs-vs-lvd-emc-ce-evidence.md): Compare RoHS substance evidence with separate LVD and EMC CE evidence streams, using RoHS-grounded scope, technical file, DoC, CE marking, exemption, and supplier records. - [RoHS vs POPs for EEE substance compliance](/artifacts/eu/rohs-directive/rohs-vs-pops.md): Compare EU RoHS and POPs obligations for electrical and electronic equipment: scope, substances, evidence, CE files, exemptions, waste overlap, and source-linked decision rules. - [RoHS vs REACH for electronics: scope, evidence, overlap](/artifacts/eu/rohs-directive/rohs-vs-reach.md): Compare EU RoHS and REACH for electrical and electronic equipment: scope, restricted substances, evidence, CE marking, exemptions, and overlap decisions. - [RoHS vs WEEE: EU electronics compliance comparison](/artifacts/eu/rohs-directive/rohs-vs-weee.md): Compare EU RoHS restricted-substance duties with WEEE end-of-life recycling obligations, with RoHS scope, evidence, CE marking, exemptions, and source-linked decision points. - [RoHS, REACH, POPs, and batteries overlap](/artifacts/eu/rohs-directive/reach-pop-and-batteries-overlap.md): source-linked RoHS comparison guide for separating EEE hazardous-substance restrictions from REACH, POPs, battery, waste, and technical-file workstreams. - [What do the 0.1% and 0.01% substance limits mean under EU RoHS? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/0-1-and-0-01-limits.md): RoHS FAQ explaining why most Annex II substances use a 0.1% homogeneous-material limit while cadmium uses 0.01%. - [What should teams do before a RoHS exemption expires? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/exemption-expiry.md): How to handle EU RoHS exemption expiry: confirm the Annex entry, renewal deadline, pending-decision status, fallback plan, and technical-file evidence. - [When can RoHS spare parts use transition rules? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/spare-parts.md): EU RoHS FAQ on spare parts, repair parts, reused parts, closed-loop B2B reuse, legacy EEE cutoffs, Annex III and IV exemptions, and evidence to keep. - [Which EEE is in scope under EU RoHS? | RoHS FAQ](/artifacts/eu/rohs-directive/faq/eee-scope.md): EU RoHS scope FAQ explaining when a product is electrical and electronic equipment, which Article 2 exclusions to check, and what evidence to keep. --- [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). All rights reserved. Source: https://www.sorena.io/artifacts/eu/rohs-directive/medical-devices-and-monitoring-equipment