Medical devices manufacturers and pharma companies alike should review their compliance strategies as the EU Medical Device Regulation Date of Application approaches. Now that there are less than four ...

Why fewer unannounced audits endanger patient safety and why something must happen before action is taken, explains Mark ...

The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...

The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”). The ...

More than half of medical device companies in the EU have reduced their product portfolios to cope with the complexities of the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation ...

On 16 December 2025, the European Commission (EC) published a proposal that, if adopted, will harmonise artificial intelligence (AI) Act requirements for medical devices placed on the European market ...

Due to the grave shortage of notified body capacity and the sheer amount of medical devices and in-vitro medical devices (IVD), which need to be recertified under the new legislative framework, most ...

The European Commission’s (EC’s) Directorate-General for Health and Food Safety recently published a survey of notified bodies. This was conducted between April and May 2023, eliciting responses from ...

The Medical Device Coordination Group (MDCG), a medtech group that advises the European Commission, recently published a guidance on the ethylene oxide’s (EtO) regulatory status under the Medical ...