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…
Highlights of the week
We are happy to announce our collaboration with Team-PRRC, who recently joined Our Network. Our Library of documents was updated with: Guidance on regulatory requirements…
How many MDR/IVDR Notified Bodies we have by June 2020?
Approaching second half of 2020, NANDO database currently lists 14 Notified Bodies accredited under the MDR with updates to listing of BSI Group The Netherlands…
MDCG: Consultation under MDR Article 52(9) for (AI)MDD certified devices
The MDCG issued a Guidance on the conformity assessment procedure for special category of devices as per the Article 52 of the MDR: ‘‘for devices…