To improve MDlaw experience and to keep you informed of all the relevant publications of the first four months of 2021, we present the below…
Update to MDCG UDI Guidance & Minutes from the recent MDCG meetings released!
Guidance on BASIC UDI-DI and changes to UDI-DI The new revision of the MDCG guidance on the Unique Device Identification (UDI) system for medical devices…
Clinical investigations under MDR: MDCG Q&A
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…
State of the art of COVID-19 rapid antibody tests and state of the art & IVDR
The IVDD requires from the manufacturers to design and manufacture devices in such a way that they are suitable for the intended purpose, taking into…
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…