The European Commission is proposing to delay the MDR for 12 months to fight the current COVID-19 outbreak! Watch a short video following today’s European…
We have the 12th NB under the MDR!
Over the weekend, the European Commission updated the NANDO website and announced the designation of another Notified Body (NB) under the MDR – (EU) 2017/745:…
Notified Body designations: Updated State of play
The European Commission released the updated State of play on the designation process of the Notified Bodies under the MDR and IVDR. As it is…
More MDCG guidance released!
The MDCG endorsed two new documents, which brings us to three MDCG guidance’s in the past day! 2020-01 Guidance on Clinical Evaluation (MDR) / Performance…
Guidance on significant change for legacy devices (MDR)
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…