Europe – Questions and Answers: Commission proposes an extension of the transitional periods for...
The EU rules on the safety and performance of medical devices were created in the 1990s. In April 2017, the European Parliament and the...
Europe – MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy...
Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU)
2017/746 on in vitro diagnostic medical devices (IVDR), in particular its Article 110(3),
in terms of...
Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems
On September 28, 2022, the European Commission published its long-promised proposal for an AI Liability Directive. The draft Directive is intended to complement the...
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...
Europe – MedTech Europe’s vision for a resilient medical technology ecosystem
The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring...
Europe – EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation
The Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), now fully applicable since 26 May 2022, introduces substantial changes to the diagnostic sector. EFPIA fully supports...
UK – E-cigarettes: regulations for consumer products
The MHRA is the competent authority for a notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland and is responsible...
Europe – Lancement d’un groupe de travail européen sur l’évaluation des DM numériques (ANS)
PARIS (TICpharma) - Un groupe de travail européen sur l'évaluation des dispositifs médicaux (DM) numériques a débuté ses travaux en vue de "parvenir à...
Europe – Nouvel Organisme Notifié au titre du règlement (UE)2017/746
Nouvel Organisme Notifié au titre du règlement (UE)2017/746 :
National Standards Authority of Ireland (NSAI)...
Europe – Machine Learning-enabled Medical Devices: Key Terms and Definitions
Artificial Intelligence (AI) is a branch of computer science, statistics, and engineering
that uses algorithms or models to perform tasks and exhibit behaviors such as...
