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…
Clinical investigations under the MDR: MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) has published a guidance document on Safety reporting in…
Planning of MDCG guidance documents updated
You will find below the updated document on the ongoing work of the MDCG and…
New MDR NB designation + MDCG addressing COVID-19 outbreak
NANDO is richer for a new MDR accredited Notified Body, which brings us to 13…
MDCG: PMCF Templates, Equivalence, Clinical evidence for legacy devices
The European Commission also released this morning 4 important MDCG documents covering PMCF, namely template…
MDR delay is official – new Regulation published in the Official Journal!
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020…
MDR delay approved also by the Council!
The Council of the EU agreed to the position of the European Parliament in a…
