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…
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…
Update to the NB designation process
The European Commission released an updated overview of the Notified Body accreditation process under the EU MDR and IVDR. As of 13 of July 2020,…
New MDR NB designation
The French Notified Body GMED is newly listed on the NANDO website, and is the 15th Notified Body accredited under the Regulation (EU) 2017/745 on…
UDI for systems and procedure packs: Example added to MDCG Guidance
The MDCG updated its 2018-3 Guidance on UDI for systems and procedure packs, and added the below, highlighted example to the exemption under Section 3.2…