The MDCG updated its Interpretation document on Article 54 (2)b of the MDR that exempts certain already marketed class III and class II devices from…
EC Proposal to delay MDR: which provisions are affected?
The European Commission proposal for the MDR delay is now officially published and accessible through: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589 Proposal for a Regulation of the European Parliament and…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6 months. Next meeting of the MDCG is only planned for…
MDR delayed for 12 months due to COVID-19?
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…