Information on the Medical Devices Regulation

Recommendation

2/3 May 2024

Process Validation - Live Online Training

After long affirmations that the EUDAMED database would be available until 26 May 2020, the EU Commission finally announced at the end of October that this would not be the case. The postponement is scheduled for 2022. However, since the EUDAMED database is intended for various registrations and also for vigilance considerations, it will be interesting to see how the Commission will proceed.

With the entry into force of ISO 13485:2016, medical device manufacturers have been faced with changes. For many manufacturers of medical devices, this standard serves as the basis for their management system. The document presents differences to the requirements of the still valid medical device guidelines (e.g. 93/42/EEC) via matrices in annexes (ZA, etc.). The new Medical Devices Regulation also goes beyond ISO 13485:2016 in some aspects. The document CEN/TR 17223:2018 "Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation" provides some assistance in this regard. It shows where ISO 13485 meets the MDR (and IVDR) and where gaps exist. The standard can be purchased from the Beuth-Verlag publishing house for example.

As a result of the MDR, the Notified Bodies will also be re-evaluated. Anyone who has successfully completed the evaluation procedure will be announced on the NANDO website of the EU, which is constantly updated.