‘’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…
Highlights of the week
Please be informed that our Library of Documents is richer for the below documents, published…
MDR: 16th NB Designation
Over the weekend, the NANDO database has been updated with a new name. The German…
New MDCG Guidance for Notified Bodies
The MDCG issued a new Guidance for notified bodies on the use of MDSAP (Medical…