Actor Registration to EUDAMED shall be available from next Tuesday (1.12.2020), as communicated earlier on this Platform. The European Commission now released a very useful…
Building a European Health Union: medical device shortage addressed
The European Commission presented its new Communication Building a European Health Union: Stronger crisis preparedness and response for Europe and three Proposals for a Regulation…
Designation process of MDR/IVDR Notified Bodies – update
The EU Commission has recently released a graphic that numerically reflects how many Notified Bodies are currently undergoing the different enabling steps to eventually be…
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 EUDAMED, where it confirmed that the actor registration module will…
What is a Regulatory Strategy?
‘’Regulatory strategy’’ or ‘’strategy for regulatory compliance’’ is a new concept in the EU regulatory framework on medical devices introduced by the upcoming Regulation (EU)…
Upcoming MDCG WG meetings – October 2020
The MDCG Working Groups will be discussing interesting points in the upcoming October meetings: EMDN Overview of EMDN development [for more information on EMDN, have…
MDR/IVDR Implementing acts in Q4 2020
As per the Commission MDR/IVDR Implementation Rolling Plan, we can expect the following Implementing acts in the last quarter of 2020: Common specifications for products…
MDR:17th NB Designation
Since this morning, the NANDO database is richer for a new certification body. The Notified Body 3EC International a.s. is the 17th Notified Body notified…
Brexit & EU MDR/IVDR: Update from MHRA
The UK Competent Authority (MHRA) shared today some important insights with specific deadlines on how it shall regulate medical devices after 1 January 2021. The…
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 by national law. In fact, when reprocessed and used within…