Europe – Votre avis sur l’extension de la période de transition des RDM et...

La Commission européenne va soumettre au Parlement européen et au Conseil une proposition d'amendement modifiant les règlements (UE) 2017/745 (RDM) et (UE) 2017/746 (RDMDIV) en ce...

Europe – MDCG 2023-2 List of standard fees

Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish...

Europe – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of...

Medical devices can be manufactured and used within EU health institutions (in-house devices), on a non-industrial scale, to address the specific needs of target patient...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – MDR transition delay needs clarification, industry engagement to succeed

Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the...

UK – Artificial pancreas technology set to change lives

Individuals who are typically unable to manage their type 1 diabetes will be offered new technology to help them control their condition. Furthermore, the...

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...
Advice for Management of Clinical trials in relation to Coronavirus

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 – The designation of notified bodies under the upcoming Artificial Intelligence Act

Artificial Intelligence (AI) algorithms, in its various forms, machine learning, deep learning, etc., implemented as embedded software (SW) or standalone SW, are gaining in...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medical devices: UK approved bodies

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
COVID-19 outbreak: the presidency steps up EU response by triggering full activation mode of IPCR

Europe – European Commission Proposes Extending MDR, IVDR Transition Periods

At the EPSCO Health Council on 14 June 2022, Health Ministers expressed their concerns that severe challenges related to the implementation of Regulation (EU)...

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