‘’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…
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…
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…
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…
MDR/IVDR Standardisation Request
As we can read in the recently published minutes from the 19th June meeting of the MDCG sub-group on Standards, CEN and CENELEC rejected the…