EU MDR Checklist

Start with the product claim, not 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. Confirm whether a notified body is required, 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 file 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.

Do not treat standards as a substitute for 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 file 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.

The GSPR checklist should be a traceability table, not a yes/no assertion. 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. Commission guidance states that manufacturers must submit UDI/device information in EUDAMED for devices placed on the EU market, and that the UDI/Devices module becomes mandatory to use from 28 May 2026 under the cited transitional provisions.

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.

Legacy-device status should be documented as a controlled exception, not as 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. The 2023/607 amendment sets different transition end dates by device category and adds conditions, including a QMS by 26 May 2024 and a notified-body application and written agreement by the specified 2024 dates. If any condition is missing, escalate before shipment or change approval.