SGS FIMKO OY has joined the list of certification bodies notified under the Regulation (EU) 2017/745 on medical devices and displayed on the NANDO website…
MDR & IVDR: How many NBs we have?
The end of Brexit transition period (31/12/2020) has brought many important changes also for the medical device community. Today, we highlight the removal of UK-based…
Update: EC Implementing acts and MDCG Guidance in 2020 & 2021
With the release of the latest Implementation Rolling Plan, we present below future implementing acts/actions by the European Commission and respective dates of publication: Q1…
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…