The MDCG issued a Questions & Answers (Q&A) document aimed at assisting sponsors by clarifying certain aspects of clinical investigation of medical devices within the…
MDCG guidance on standardisation for medical devices
The MDCG document pursues to provide guidance on several features related to standards in the medical devices industry supporting the requirements set down in the…
Standardisation request for the EU MDR & IVDR
The European Commission has notified today CEN and Cenelec of the Standardisation request in the Implementing Decision C(2021) 2406, which will serve as the basis…
IVDR Certification of Class D devices, Implementation Plan and MDR NB
The MDCG released an important Q&A for manufacturers of Class D devices and their certification during the transition period – until 26 May 2022 or…
Switzerland: precautionary measure ahead of 26 May 2021
In the light of the upcoming renewal of the Mutual Recognition Agreement (MRA) between Switzerland and the European Union, the Swiss Federal Office of Public…
MDCG Guidance on MDR custom-made devices
The MDCG issued a dedicated Questions & Answers on the most pertinent matters concerning custom-made devices, adaptable medical devices and patient-matched medical devices as regulated…
EUDAMED: State-of-play
Despite projections that it will be possible to perform device and Certificate registration directly to EUDAMED from May 2021 – aligning with the MDR date…
Overview of published documents – February 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the previous month that have been collected in our Library of…
MDCG Guidance on practices and solutions until EUDAMED is fully functional
MDCG issued its first 2021 guidance that clarifies to Member States and other parties on the application of certain MDR provisions during the absence of EUDAMED.…
MDR: 19th Notified Body on NANDO!
The NANDO database newly lists 19 Notified Bodies under the MDR! ISTITUTO SUPERIORE DI SANITA has been notified under the Regulation (EU) 2017/745 on medical…