Update on the process CAMD Roadmap actions on the MDR Implementation 51 actions: work in progress and will be published soon 49 actions: leader has…
MDR: New NB designation
The European Commission announced the 11th Notified Body designated under the Regulation (EU) 2017/745: National Standards Authority of Ireland (NSAI) 1 Swift Square, Northwood, Santry…
We have the 10th NB under the MDR!
This morning, the European Commission updated the NANDO website and announced the designation of another Notified Body (NB) under the MDR – (EU) 2017/745: DNV…
Risk Management
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…