Posts tagged with "(EU)2017/746"



12. December 2019
In the MDCG 2019-13 the EU Commission publishes further details on the sampling of the technical documentation for review by the Notified Body during the conformity assessments of Medical devices and IVDs. The guidance explains how to identify product categories ( (for Class IIa and Class B) and generic product groups (for Class IIb and Class C) . Manufacturers will need to utilize two "coding" systems: The MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185, which is...

30. October 2019
As confirmed by a statement on the Commission's website the MDR portion of the EUDAMED Database will be operational at the same time as the IVDR portion.The statement concerning the state of play is following: The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro...

30. October 2019
According to the latest publication on the NANDO Website the BSI UK, was designated as the SECOND IVDR Notified Body but as the first with the full scope.

10. October 2019
Dekra Germany is designated as the first Notified Body under the IVDR. The official designation can be found here.

25. August 2019
Der erste Entwurf für den Nachfolger des Medizinprodukte Gesetz MPG ist veröffentlicht als Medizinprodukte Durchführungs Gesetz MDG

20. July 2018
The Factsheet for Manufacturers of Medical Devices was published by the EU Commission.

22. January 2018
After the Brexit manufacturers need to find a new Authorized representative and a new Notified Body if they use these service Providers in the UK.

18. January 2018
FAQ for the application and transition of the MDR (EU)2017/745

07. December 2017
The Borderline Working group chaired by the EU Commission published the updated Version 1.18 of the "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES". The document is intended to act as a guidance for the interpretation of the MDD and IVD. The new paragraphs introduced by the update are identified by the pictogram "New" and include the products: Products intended to reduce the effect of alcohol Radiation shields D-mannose for the prevention of...

26. November 2017
Switzerland paves the road for the implementation of the MDR requirements into national legislation.

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