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MDR
All our articles on MDR 2017/745: manufacturer obligations, classification, notified bodies, EUDAMED, UDI and medical device compliance.
14 articles
MDR Vigilance: Who Reports What, and Within What Deadline
A serious incident must be reported within 2, 10 or 15 days depending on its severity. The clock starts when the incident becomes known, not when the causal link is confirmed: this is precisely where vigilance systems are caught out.
UDI: the Unique Device Identification system for medical devices
Four issuing entities, three identifiers, two separate timelines for the label and for EUDAMED. The part that really commits you is played out before the first code: in the grouping logic of the Basic UDI-DI.
Rule 11 of MDR Annex VIII: why so much software changed class
Class IIa by default, two exceptions upward: Rule 11 changed the regulatory regime of most decision-support software. Since June 2025 the reference guidance has been revised, and earlier classifications need to be reread against the new text.
PRRC: the Person Responsible for Regulatory Compliance
Recruit or contract: Article 15 does not set the same requirement depending on the size of the manufacturer. Qualifications, tasks defined to the letter, outsourcing reserved for micro and small enterprises: the function appears on many organisation charts, less often in practice.
MDR notified bodies: role, selection and real timelines 2026
Between 45 and 50 bodies designated under the MDR, timelines observed from 9 to 30 months depending on the class, and one variable the manufacturer controls entirely: the maturity of the file it submits. Selection method, designation codes, transfer conditions.
MDR 2017/745: what really changed compared with Directive 93/42/EEC
The MDR did not revise the directive, it changed its logic: clinical evidence, continuous surveillance, end-to-end traceability. For directive certificates still in force, Article 120 set the final deadlines: end of 2027 and end of 2028.
EUDAMED: what it is for and how to register
Provided for by the MDR and the IVDR, EUDAMED centralises the regulatory data of medical devices across six modules. Since 28 May 2026, four of them are mandatory. Everything starts with registration in the Actors module and obtaining the SRN, without which nothing else is accessible.
MDR and custom-made devices: a regime in its own right, often misapplied
Manufactured on request does not mean custom-made within the meaning of the Regulation: three cumulative conditions govern this status. The absence of CE marking does not mean the absence of MDR compliance — almost the entire Regulation still applies.
What is a medical device under the MDR? The borderline cases that trap manufacturers
MDR qualification rests first and foremost on the intended purpose claimed by the manufacturer, not on the form or technology of the product. Software, cosmetics, wellness products, Annex XVI aesthetic products and accessories are all borderline cases where a poorly controlled claim is enough to push a product into a more demanding regulatory framework.
The EU declaration of conformity: mandatory content and common mistakes
Annex IV of the MDR sets a precise mandatory content, and a template inherited from Directive 93/42 no longer holds any value: citing standards withdrawn from the OJEU or signing without authority is enough to create a non-conformity.
Devices Manufactured and Used In-House by Health Institutions (Article 5.5 MDR)
Article 5(5) of the MDR allows health institutions to manufacture and use certain devices in-house, subject to strict cumulative conditions: a patient need not met by the market, an appropriate QMS, general safety and performance requirements, documentation, a public declaration and follow-up. Contrary to a widespread belief, no notified body intervenes systematically, whatever the class.
MDR Article 120: the transitional regime, what remains valid and until when
The extended regime renews no certificate automatically: it rewards manufacturers that filed their application before 26 May 2024 and signed an agreement with a notified body before 26 September 2024, subject to five cumulative conditions.
Article 10 MDR: what obligations for the medical device manufacturer?
Article 10 places on the manufacturer an obligation of system, not a list of formalities: QMS, technical documentation, PMS, vigilance and EUDAMED data kept consistent across the entire life cycle. Documentation is retained for at least 10 years, 15 for implantable devices.
MDR GSPR: what notified bodies really check in your technical documentation
Risk management, clinical evaluation, biocompatibility, cybersecurity, labelling: all the evidence in a technical documentation exists to demonstrate conformity with the GSPRs of Annex I. It is also the first thing notified bodies examine.
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