The French Notified Body GMED is newly listed on the NANDO website, and is the…
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…
Highlights of the week
We are happy to announce our collaboration with Team-PRRC, who recently joined Our Network. Our…
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…
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…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
COVID-19: MDCG on NB designation renewals + surveillance
Following the Commission Implementing Regulation published last week, the MDCG published a guidance this morning…
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…
Manufacturer Incident Report + MDR consolidated version
Please be aware that there were new/updated forms published on the Commission website with regard…
New NB under the MDR!
This morning, a Swedish notified body joined the NANDO database of certification bodies accredited under…