EU MDR Checklist

Start with the product claim rather than the engineering label. MDR qualification turns on the intended purpose shown in labels, instructions for use, promotional material, sales claims, and the clinical evaluation. Record whether the item is a medical device, accessory, Annex XVI product without an intended medical purpose, custom-made device, system, procedure pack, software, or a borderline product that needs escalation.

Name the economic-operator role for the evidence pack. The checklist should identify the manufacturer, authorised representative where the manufacturer is outside the Union, importer, distributor, and any person assembling systems or procedure packs. That role map determines who owns technical documentation, registration, UDI, vigilance, and authority-response records.

Classify the device under Annex VIII before choosing the conformity route. The record should show the applicable rule, duration of use, invasiveness, body contact, active function, software decision impact, medicinal substance or tissue component, sterile or measuring function, and the reason the highest applicable class was selected.

Use the classification to select the conformity assessment route under Article 52 and Annexes IX, X, or XI. Class IIa, IIb, and III devices generally require a notified body. Most class I devices use manufacturer self-declaration, but sterile class I devices, class I devices with a measuring function, and reusable surgical instruments need notified-body involvement limited to sterility, metrology, or reuse controls. Confirm whether the body is designated for the device scope and whether the application, contract, audit, technical-documentation assessment, surveillance, and certificate records are complete.

Build the technical file around Annex II and Annex III rather than around a generic document list. The record should identify the device and Basic UDI-DI, intended purpose, classification rule, design and manufacturing information, GSPR checklist, benefit-risk analysis, verification and validation data, clinical evaluation, PMS plan, and PMS outputs. Article 10 requires the manufacturer to retain the technical documentation, declaration, and relevant certificates for at least 10 years after the last covered device is placed on the market, or at least 15 years for implantable devices.

Use standards to support, rather than replace, the GSPR file. Where harmonised standards or common specifications are used, record exactly which requirements they cover and where the design uses another solution. The record should let a notified body or competent authority trace each safety and performance claim to design evidence, risk controls, verification, validation, clinical evidence, and PMS updates.

Use the GSPR checklist as a traceability table. For each applicable Annex I requirement, list the hazard or performance claim, risk-control measure, verification or validation evidence, standard or common specification where used, residual-risk conclusion, and owner.

Clinical evidence should stay connected to intended purpose and risk. The clinical evaluation plan and report should identify the GSPRs needing clinical data, the target groups, clinical benefits, outcome parameters, literature strategy, clinical investigations or equivalence rationale, favourable and unfavourable data, and PMCF plan where needed.

Assign and control Basic UDI-DI, UDI-DI, and UDI production identifiers before release evidence is frozen. The checklist should show the issuing entity, assignment rules, label placement, packaging levels, device registration data, and change controls for events that require a new UDI-DI.

Confirm EUDAMED duties separately from label generation. Since 28 May 2026, the Actor, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance modules have been mandatory under the gradual-rollout provisions. The Clinical Investigations and Vigilance/PMS modules have separate later milestones, so do not describe all six modules as fully mandatory.

PMS is a live input into the technical file. The MDR requires manufacturers to proactively collect and review experience from devices on the market, update technical documentation, and use PMS outputs to support corrective and preventive actions, risk management, clinical evaluation, PMCF, and transparency records.

Separate PMS reporting from vigilance reporting. Class I devices need a PMS report; class IIa, IIb, and III devices need PSURs at the MDR frequency. Serious incidents and field safety corrective actions must be reported through the vigilance system within the MDR timelines, with trend reporting where the frequency or severity of non-serious or expected incidents could affect benefit-risk.

Document legacy-device status as a controlled exception rather than a general grace period. For devices relying on the amended Article 120 transition, record the old certificate or declaration basis, continued compliance with the prior Directive, absence of significant design or intended-purpose changes, MDR QMS status, notified-body application status, written agreement status, and which MDR PMS, market surveillance, vigilance, and registration duties already apply.

Use the transition record to drive release and change-control decisions. For covered devices, Regulation (EU) 2023/607 sets 31 December 2027 for specified class III and class IIb implantable devices, and 31 December 2028 for other covered class IIb and class IIa devices, class I sterile or measuring devices, and formerly self-declared devices that now require a notified body. The extension is conditional, including continued Directive compliance, no unacceptable risk, no significant design or intended-purpose change, an MDR QMS by 26 May 2024, a formal notified-body application by 26 May 2024, and a written agreement by 26 September 2024. If any condition is missing, do not assume the later date applies.