EUDAMED Actor Registration: European Commission Q&A
Actor Registration to EUDAMED shall be available from next Tuesday (1.12.2020), as communicated earlier on…
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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…
MDR:17th NB Designation
Since this morning, the NANDO database is richer for a new certification body. The Notified…
Brexit & EU MDR/IVDR: Update from MHRA
The UK Competent Authority (MHRA) shared today some important insights with specific deadlines on how…
Common specifications for reprocessing of single-use devices published
The MDR (Regulation (EU) 2017/745) allows reprocessing of single-use devices only where it is permitted…
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…
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