The NANDO database newly lists 18 Notified Bodies under the MDR! UDEM Adriatic is the 18th Notified Body (17th within the Union) notified under the…
COVID-19 & NB audits: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document concerning the previously issued Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19…
Actor registration to EUDAMED is now possible!
Actor module of EUDAMED is active as of December 1, 2020! It is now possible to register yourself as an economic operator and obtain the…
IVDR: 5th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! TÜV Rheinland LGA Products GmbH is the 5th Notified Body (4th within…
EUDAMED Actor Registration: European Commission Q&A
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…
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 notified bodies and health institutions, which shall provide guidance on…
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)…