UK – Exceptional use of non-UKCA marked medical devices
A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is...
Europe – UPDATE – MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the...
Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with...
UK – New device launched for diagnosing prostate cancer
CamPROBE may save vital time and money while reducing the risk of infection
November will witness the launch of a new device that is set...
Europe – Update – MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations.
This...
Europe – MDCG 2022-14 – Transition to the MDR and IVDR – Notified body...
The MDCG recognises that significant and urgent challenges remain in ensuring sufficient
capacity of notified bodies and readiness of manufacturers in order to allow medical...
Europe – MDCG 2022-18 : Position Paper on the application of Article 97 MDR...
In accordance with Article 5 of Regulation (EU) 2017/745 on medical devices (MDR),
a device may be placed on the market only if it complies...
Europe – Le règlement (UE) 2023/607
Le règlement (UE) 2023/607, publié au JOUE, modifie les dispositions transitoires relatives à certains dispositifs médicaux et à certains dispositifs médicaux de diagnostic in...
Europe – Data generated from ‘Off-Label’ Use of a device under the EU Medical...
‘Off label use’ is mentioned within the Medical Device Regulation (MDR) in Annex XIV Part B, in the context that manufacturers should proactively identify...
Europe – Santé publique: plus de temps pour certifier les dispositifs médicaux afin de...
La Commission a adopté aujourd'hui une proposition visant à accorder plus de temps certifier les dispositifs médicaux afin de limiter le risque de pénuries. La...