Actor Registration to EUDAMED shall be available from next Tuesday (1.12.2020), as communicated earlier on…
IVDR: MDCG Guidance on Classification Rules for in vitro diagnostic medical devices released!
The MDCG published a very important document for all IVD manufacturers, as well as for…
Building a European Health Union: medical device shortage addressed
The European Commission presented its new Communication Building a European Health Union: Stronger crisis preparedness…
Designation process of MDR/IVDR Notified Bodies – update
The EU Commission has recently released a graphic that numerically reflects how many Notified Bodies…
EUDAMED – Actor registration: new Commission webpage with important guides & templates
The European Commission has launched a new webpage dedicated to the Actor registration module of…
What is a Regulatory Strategy?
‘’Regulatory strategy’’ or ‘’strategy for regulatory compliance’’ is a new concept in the EU regulatory…
Upcoming MDCG WG meetings – October 2020
The MDCG Working Groups will be discussing interesting points in the upcoming October meetings: EMDN…
MDR/IVDR Implementing acts in Q4 2020
As per the Commission MDR/IVDR Implementation Rolling Plan, we can expect the following Implementing acts…
Brexit & EU MDR/IVDR: Update from MHRA
The UK Competent Authority (MHRA) shared today some important insights with specific deadlines on how…
New MDCG Position Paper on EUDAMED actor registration module and SRN released
On 18.08.2020, the MDCG published a Position Paper on the use of the EUDAMED actor…