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…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts/actions to take with different…
COVID-19: MDCG on NB designation renewals + surveillance
Following the Commission Implementing Regulation published last week, the MDCG published a guidance this morning to layout common criteria for the renewal of Notified Body…
Commission Implementing Regulation on NB designations + Commission Communication on Union-wide derogations
Our Library of Documents is richer for two more documents addressing the COVID-19 pandemic: Commission Implementing Regulation: renewal of designations and the surveillance and monitoring…