MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK to strengthen regulation of medical devices to protect patients

MHRA to reform medical devices regulation to improve patient health and encourage innovation The UK is seizing the opportunities provided by leaving the...

Europe – Questions and Answers on Certificates of Free Sale and Article 60 of...

This Questions and Answers document was developed by competent authorities, with the aim of providing guidance in the area of Certificates of Free Sale. It...

Europe – CAMD Statement – 50th CAMD Plenary meeting

In the context of the French Presidency of the EU Council, during its 50th plenary meeting, CAMD adopted a statement, following discussions about transition to...

USA – FDA takes a step forward for machine learning with quantitative imaging guidance

The US Food and Drug Administration finalized guidance on what to consider when using quantitative imaging algorithms in radiological device submissions. While most imaging...
MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates

UK – MHRA joins international partnerships to set global standards for medicines and medical...

The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the...

Europe – MDCG 2022-11 MDCG Position Paper Notice to manufacturers to ensure timely compliance...

With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has changed...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

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...
Vers une plus grande coopération des pharmacopées mondiales

Europe – Exercer la fonction de PCVRR : où en sommes-nous aujourd’hui ?

Le règlement européen (UE) 2017/745 (RDM) est applicable depuis le 26 mai 2021, et tous les fabricants qui mettent sur le marché des dispositifs...
Double peine pour la medtech suisse

Europe – New Swiss IVD regulations come into force as EU mutual recognition agreement...

A mutual recognition agreement (MRA) aligning in vitro diagnostic (IVD) regulations between the European Union and Switzerland has officially expired following the In Vitro...

Europe – Artificial intelligence in healthcare

In recent years, the use of artificial intelligence (AI) in medicine and healthcare has been praised for the great promise it offers, but has...

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