All manufacturers making use of the grace period as per the Article 120 (3) of the MDR – with a CE Certificate issued under the…
MDCG Joint Implementation/preparedness plan on MDR
The MDCG just publicly announced that the Actor registration will be available in EUDAMED by May 2020! This means that manufacturers will be for ex.…
MDR: Consolidated text
We are happy to share with you that the consolidated version of the MDR – Regulation (EU) 2017/745 was published on EUR-lex. The new text…
MDR implementation update and timeline
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)…