Transcript
The Medical Devices Regulation decides whether a device can carry the CE marking and be placed on the EU market at all.
It applies to manufacturers, authorised representatives, importers and distributors, and to everything from plasters and contact lenses to surgical instruments, implants and medical software, sorted into four risk classes.
It entered into force in 2017 and has been fully applicable since 26 May 2021, replacing the Medical Devices Directive; Regulation 2023/607 extended the transition periods for legacy devices.
You classify the device, engage a notified body above Class I, build technical documentation and a clinical evaluation, assign UDIs and register in EUDAMED, run post-market surveillance and vigilance, and draw up an EU declaration of conformity with CE marking.
Conphora matches your devices against MDR, flags gaps before they become market-access problems, organises the conformity evidence, and alerts you when rules or transition deadlines change.
The full guide is at conphora.com.
MDR Video
MDR: Explained in 60 seconds
MDR guide: the Medical Devices Regulation, what counts as a medical device, the risk classes and conformity routes, UDI and Eudamed, vigilance, the legacy-device transition to 2027 and 2028, and what manufacturers, importers and distributors must do.
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Key moments
- 0:01 The Medical Devices Regulation decides whether a device can carry the…
- 0:10 It applies to manufacturers, authorised representatives, importers and…
- 0:26 It entered into force in 2017 and has been fully applicable since 26…
- 0:44 You classify the device, engage a notified body above Class I, build…
- 1:03 Conphora matches your devices against MDR, flags gaps before they…
- 1:17 The full guide is at conphora.com
About this film
Rendered from the regulation guide's facts and narrated in English; captions and the transcript follow the page's language. Facts only — the guide carries the sources.