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...
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...
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...
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...
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...
Switzerland – Switzerland joins EU in bringing in new IVD requirements to improve patient...
The new ordinance on In vitro Diagnostic Medical Devices (IvDO) has come into force in Switzerland, bringing in stricter requirements for conformity assessment and...
Europe – New guidance from European MDCG ahead of date of application
European regulators have issued several new guidance documents relevant to medical device and in vitro diagnostic (IVD) manufacturers days before the In Vitro Diagnostic...
Europe – Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials
Now that the IVDR 2017/746 has taken effect, new guidance for in vitro diagnostic (IVD) manufacturers with assays used in clinical trials has been published. Assays...
