The rumors on the revised transitional provision [Article 120(3) of the MDR] are confirmed, as…
6th and 7th MDR Notified Body designated
The European Commission announced two more Notified Body designations under the Medical Device Regulation in…
EUDAMED delayed!
The European Commission officially announced the delay of the EUDAMED database to May 2022: ”…
Timeline for future MDCG documents published!
Albeit half of the deadlines for the endorsement of MDCG Guidance is not yet defined…
EMA Q&A Document on implementation of MDR and IVDR update released.
Questions and Answers document updated version has been released on 21.10.2019 by the European Medicines…
Updated version of MDCG Q&A Document released in June 2019
The MDCG has updated the useful Questions & Answers document focusing on the Notified Bodies’…
SOFTWARE: Qualification and classification
On the 11th of October 2019, the MDCG issued a Guidance on the qualification and…
NB designation process – Final Assessment Form
You can have a look at the final assessment form for the designation of a…
MDCG: MDR Transitional regime
The MDCG published on Friday a guidance document, where it further clarified Article 120 (2),…
Summary of safety and clinical performance: Content, Template by MDCG
The MDCG published a guidance document, specifically targeted at manufacturers and Notified Bodies, on the…