RequirementsEU

EU Medical Device Regulation (MDR) 2017/745 Requirements

Core obligations and the evidence you need to prove them.

Use this page as a map: each requirement group links to a deeper guide or template.

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Author

Sorena AI

Published

Feb 22, 2026

Updated

Feb 22, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 22, 2026

Updated Feb 22, 2026

Overview

MDR requirements are easier to manage when you translate them into concrete outputs: memos, procedures, records, reports, and registry entries. Use the sections below as a minimum evidence map for audits, notified body reviews (where applicable), and market surveillance questions.

Section 1

1) Scope, intended purpose, and economic-operator roles

Your route starts with intended purpose and role. Scope determines whether MDR applies. Role determines which checks you perform yourself and which checks you must verify from somebody else.

Evidence output: scope memo, role map, contract matrix, and borderline or Annex XVI analysis where relevant.

Define intended purpose in the label, IFU, UI outputs, and marketing so the same medical claim appears everywhere or nowhere.
Identify the role for each legal entity: manufacturer, authorised representative, importer, distributor, and where relevant system or procedure pack producer.
For software, document whether the software itself has a medical purpose, drives a device, or only supports an administrative process.
If you rely on legacy transition, remember that MDR post-market surveillance, vigilance, market-surveillance, and registration rules replace the corresponding directive rules for those legacy devices.
Keep change triggers in the scope memo: new indications, new users, new environments, new automation, new data inputs, or new claims should all force re-review.

Section 2

2) Classification, conformity assessment, and transition route

Classification drives route, lead time, and evidence depth. Transition status does not remove the need to know the current MDR class logic because some deadlines and obligations depend on it.

Evidence output: Annex VIII classification memo, conformity-route memo, notified-body strategy, and where relevant an Article 120 legacy-device eligibility file.

Write an Annex VIII classification memo and make software Rule 11 reasoning explicit where relevant.
Choose the conformity-assessment route under Annex IX, X, or XI, and document why it fits the device and class.
If a notified body is required, map application readiness, review capacity, surveillance ownership, and transfer arrangements.
For legacy devices, keep the Article 120 conditions visible: continued directive compliance, no significant changes in design or intended purpose, QMS timing, and the application and written-agreement cutoffs where applicable.

Section 3

3) QMS, PRRC, technical documentation, clinical evaluation, PMS, and UDI

This is the real evidence chain. When one link is generic or stale, the rest of the file becomes hard to trust.

Evidence output: Annex II and III technical file, GSPR checklist, CER, PMS report or PSUR, vigilance records, UDI and EUDAMED records, and PRRC or role-governance evidence.

Article 10 manufacturer controls: keep design and change control, supplier control, complaint handling, CAPA, internal audit, management review, and technical documentation current.
Article 15 PRRC: manufacturers need at least one person responsible for regulatory compliance with the required expertise. Micro and small enterprises may keep that person permanently and continuously at their disposal instead of inside the organisation.
Article 10(9)(h): the QMS must verify UDI assignments and ensure the consistency and validity of the information submitted under Article 29.
Article 86 and Article 87: class IIa, IIb, and III devices need PSUR on the required cadence, while serious incidents follow the 15-day, 2-day, and 10-day reporting clocks depending on the event type.
Article 29 and 31: device registration and actor registration need controlled master data, and importers must verify that required registrations were done and add their own details.

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