Under the EU MDR and IVDR, the MDCG (Medical Device Coordination Group) provides advice and assists the European Commission and the Member States in ensuring…
State-of-play of NB designations
The European Commission (EC) published a document on the state-of-play of designation process of Notified Bodies under the MDR and IVDR: 44 applications received for…
European Medical Device Nomenclature
The European Commission Unit dealing with medical devices – newly under the Directorate for Health and Food Safety (move from DG GROW to DG SANTE)…
Croatian Presidency of the EU
Croatia has started presiding the Council of the European Union on the 1st of January 2020, and will remain in this role until the 30th…
MDCG Guidance on cybersecurity for MD
The European Commission published today a new MDCG Guidance, which is 16th in line, and has the purpose to help medical device manufacturers and other…
MEDCERT designated under the MDR (9th NB)
With the below German Notified Body, designated for the assessment of devices under the MDR – (EU) 2017/745, we reached the number of 9, despite…
MDCG Guidance timeline updated
Today, an updated version of the MDCG work progress was released, listing past and ongoing development of guidance documents within MDCG Subgroups. We shall still…
MDCG Guidance for Class I manufacturers!
The MDCG published today well awaited Guidance for Class I manufacturers! The MDCG enlists tasks to be carried out by a Class I manufacturer to…
8th NB designated under MDR
NANDO database is richer for another Notified Body accreditation under the Medical Device Regulation – (EU) 2017/745. Dutch Notified Body DEKRA is the 8th NB…
MDCG Guidance on MDR/IVDR device sampling + MDR Codes
The MDCG published two important guidance documents this afternoon. Firstly, an Explanatory note on MDR Codes, i.e. MDA/MDN, MDS, MDT was published. These Codes are…