A cited calendar for MDR application, legacy-device transition dates, UDI carrier timing, EUDAMED module timing, and recurring operational reviews.
Use it to separate fixed legal dates from ongoing review events for QMS, technical documentation, clinical evaluation, PMS, vigilance, certificates, and design or intended-purpose changes.
Use 26 May 2021 as the MDR application date, 31 December 2027 or 31 December 2028 as the conditional legacy-device endpoint for the applicable device group, and the class-specific UDI and PSUR cycles shown below. The first four EUDAMED modules became mandatory on 28 May 2026. This calendar separates those legal dates from device-specific review triggers.
Use these dates as the backbone of an MDR calendar. For each device family, record the applicable risk class, certificate basis, notified-body status, whether the legacy conditions are still met, and the owner responsible for keeping evidence current.
Legacy-device transition dates are conditional. Regulation (EU) 2023/607 ties the extended placement or putting-into-service windows to continued Directive compliance, no significant design or intended-purpose change, no unacceptable risk to the health or safety of patients, users, or other persons or to other aspects of public-health protection, QMS implementation by 26 May 2024, a notified-body application by 26 May 2024, and a written notified-body agreement by 26 September 2024.
Sources (2)
Grounds the 26 May 2024, 26 September 2024, 26 May 2026, 31 December 2027, and 31 December 2028 transition conditions and endpoints.
Grounds the one-year postponement that moved MDR application for medical devices to 26 May 2021.
Review transition eligibility, UDI status, EUDAMED readiness, certificate dependencies, and recurring QMS, clinical, PMS, vigilance, and change-control reviews for each device family.
Track UDI and EUDAMED separately from the legacy-device transition. The class-based dates below apply to MDR-compliant devices. Commission Q&A states that legacy devices using are not subject to the MDR UDI requirements during the extended transition, so do not apply the carrier dates to a legacy device without first confirming its regulatory status.
For UDI data, the operating control should include a change trigger: where a device data element changes but a new UDI-DI is not required, the MDR UDI database rule requires the relevant record to be updated within 30 days.
Sources (3)
Confirms that the Actor, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance modules became mandatory on 28 May 2026.
Grounds UDI carrier timing by device class, reusable-device direct marking, and UDI database maintenance, including 30-day updates where no new UDI-DI is required.
Explains that legacy devices benefiting from Article 120 transition are not subject to MDR UDI requirements during the extended transitional period.
Not every MDR calendar entry is a fixed filing deadline. Many controls are ongoing obligations that should be scheduled as review events with a trigger, evidence owner, and output record.
Set the cadence by device risk, certificate commitments, PMS plan, PMCF plan, notified-body agreement, and change-control procedure. Record whether each date comes from law, a certificate commitment, or the approved quality record.
Sources (2)
Grounds ongoing QMS, technical documentation, PMS, vigilance, UDI database, clinical evaluation, and PMCF review obligations.
Grounds the need to monitor legacy-device transition conditions, significant changes, notified-body agreements, and surveillance transfer.
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.
Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact.
EU MDR guide for Annex XVI products: listed groups, common specifications, binding reclassification rules, clinical evidence, notified-body route, transition conditions, UDI, EUDAMED, PMS, and vigilance.
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.
Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change.
Practical EU MDR checklist covering qualification, classification, conformity assessment, technical documentation, GSPR, clinical evidence, UDI, EUDAMED, PMS, vigilance, QMS, and legacy transition evidence.
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 covering Article 61, Annex XIV, clinical data sources, equivalence, PMCF, CER evidence, notified body review, GSPR, and benefit-risk support.
A cited EU MDR clinical evaluation report template covering intended purpose, GSPR linkage, clinical data appraisal, equivalence limits, PMCF, conclusions, and reviewer signoff.
EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review.
EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls.
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.
Classify an EU MDR medical device by intended purpose, Annex VIII duration, invasiveness, active-device and software rules, then document the conformity route impact.
MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance.
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 guide to Article 120 eligibility, class-based end dates, certificate validity, significant changes, surveillance, and evidence.
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 guide to Article 113 national penalties, authority measures, recalls, certificate action, and the evidence needed for a country-specific assessment.
EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records.
Cited EU MDR guide to PMS plans, PMS reports, PSURs, PMCF updates, serious incident and FSCA reporting, trend reporting, and EUDAMED evidence handling.
A cited 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.
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 guide for Article 10 manufacturer controls covering regulatory strategy, design, risk, clinical evaluation, PMS, vigilance, UDI, suppliers, CAPA, and conformity records.
EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment.
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.
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.
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 chronology for 2021 application, 2023 amendments, 2024 eligibility milestones, and conditional 2026, 2027, and 2028 transition endpoints.
EU MDR guide to Basic UDI-DI, UDI-DI, UDI carriers, EUDAMED actor and device registration, change impacts, and evidence governance.
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.
Compare MDR and AI Act scope, high-risk classification, conformity assessment, evidence, monitoring, and timing for AI-enabled medical devices.
Compare MDR compliance evidence with EU product-liability claims, responsible parties, disclosure, presumptions, damage, and the December 2026 transition.
Compare MDR medical-device scope with general product-safety fallback questions for borderline, non-medical, and Annex XVI products.
Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance.
Concise EU MDR FAQ on custom-made device definition, mass-produced exclusions, Annex XIII statements, documentation, conformity assessment, PMS, vigilance, and records to retain.
FAQ on MDR significant changes for legacy devices, including intended-purpose, design, software, material, sterilisation, clinical, QMS, notified-body, and evidence impacts.
Decide whether an EU medical device needs an SSCP, see worked class IIa, IIb, and III examples, and check the required content, evidence, publication, and update controls.
EU MDR FAQ on Basic UDI-DI grouping, device and package UDI-DIs, UDI carriers, EUDAMED registration, change triggers, and required records.
Under the EU MDR, PMCF is part of PMS and clinical evaluation. See what the plan, activities, report, updates, and retained evidence should cover.
Concise EU MDR FAQ on classification changes, intended purpose, software, notified-body route impact, certificates, technical documentation, and retained evidence.
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.
EU MDR FAQ on medical purpose claims, intended purpose evidence, software qualification, Annex XVI contrasts, and records to keep.
EU MDR FAQ on PSUR scope, content, update cadence, PMS and PMCF links, notified-body handling, EUDAMED submission, and evidence to retain.
EU MDR FAQ on when an article is a medical device accessory, how intended purpose affects classification, and what evidence to keep.
EU MDR FAQ on medical device software qualification, Rule 11 and other classification rules, modules, evidence, software changes, UDI, and EUDAMED.
EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records.