Posts tagged with "IVDR"

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

15. January 2019
The European Commission published new Templates for Manufacturers to report Serious Incidents under the MDR/IVDR and Incidents under the MDD/AIMDD/IVDDD. This does not only include an integration of the new legislation but it also strengthens the internal harmonized communication concerning incidents by also using the global harmonized categories published by the IMDRF. As a consequence the template now includes 12 pages.... The version 7.1 of the Template now also integrates the new aspects...

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