The four accredited UDI issuing entities (which were designated by the Commission Implementing Decision of 7 June 2019) released further specifications on Basic UDI-DI and…
MDR Corrigendum: Derogation for certain up-classified devices
The rumors on the revised transitional provision [Article 120(3) of the MDR] are confirmed, as a new version of the Corrigendum was published. However, the…
6th and 7th MDR Notified Body designated
The European Commission announced two more Notified Body designations under the Medical Device Regulation in the last two days: DARE!! Services B.V. Vijzelmolenlaan 7 NL-3447…
EUDAMED delayed!
The European Commission officially announced the delay of the EUDAMED database to May 2022: ” The Commission concluded that it will only be possible to…
Timeline for future MDCG documents published!
Albeit half of the deadlines for the endorsement of MDCG Guidance is not yet defined (TBD), however here below we present the documents that shall…
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 Agency (EMA). Notified bodies should seek authorisation to the EMA…
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’ requirements under MDR and IVDR. It widens the scope of…
SOFTWARE: Qualification and classification
On the 11th of October 2019, the MDCG issued a Guidance on the qualification and classification of software under the MDR and IVDR. The MDCG…
NB designation process – Final Assessment Form
You can have a look at the final assessment form for the designation of a Notified Body under MDR and IVDR, used by the Designating…
MDCG: MDR Transitional regime
The MDCG published on Friday a guidance document, where it further clarified Article 120 (2), (3) of the MDR – Transitional provisions. These provisions allow…