In view of the recently published ISO 14791:2019, our experts updated the already published MDlaw guidance document/template to assist you drawing a detailed Risk…
Annex XVI MDCG sub-group: Become an observer
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…
IVDR: 3rd NB accredited
Today, the European Commission updated the NANDO database by adding another Notified Body accredited for the assessment of devices under the In Vitro Diagnostic Medical…
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…