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…
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 registration module and of the Single Registration Number (SRN). Following…
Highlights of the week
Please be informed that our Library of Documents is richer for the below documents, published in the past week: Update to the European Commission FAQ…
MDR: 16th NB Designation
Over the weekend, the NANDO database has been updated with a new name. The German Notified Body DQS is the 16th Notified Body accredited under…
New MDCG Guidance for Notified Bodies
The MDCG issued a new Guidance for notified bodies on the use of MDSAP (Medical Device Single Audit Program) audit reports in the context of…
MDR & EUDAMED: Which information will be available to the public?
The European Commission services recently issued a Fact sheet on MDR requirements for Transparency and Public Information. The document first emphasizes the importance of transparency…
Highlights of the week (CEAR)
Clinical evaluation assessment report template released by the MDCG Clinical evaluation assessment report (CEAR) will document the conclusions of the Notified Body assessment of the…