The European Commission is seeking views on the proposed delegated regulation on derogations for the removability and replaceability of portable batteries. The list covers in…
EU guidance documents updated in April 2026
In April 2026, the European Commission issued new versions of several guidance documents for compliance of medical devices and IVDs with the EU MDR and…
Swiss authority announces inspections of PMS documentation
On 23 April, Swissmedic announced that they will be conducting a focus campaign of the requirements for post-market surveillance (PMS) of higher-risk medical devices. The…
New submission requirements for medical devices in Canada from April 2026
As of April 2026, Health Canada has implemented the Regulatory Enrolment Process (REP) as the mandatory submission pathway for medical device licence applications and related…
EU pilot programme to support breakthrough medical devices and in vitro diagnostics
The European Medicines Agency (EMA) will launch a pilot programme to support breakthrough medical devices and diagnostics with a significant positive clinical impact. This initiative…
EU harmonised standards for sterilizers for medical purposes and hearing aids
The Official Journal of the EU published new harmonised standards for sterilizers for medical purposes and hearing aids. With Commission Implementing Decision (EU) 2026/760 published…
US FDA Quality Management System Regulation: alignment with ISO 13485:2016
In January 2024, the US Food and Drug Administration (FDA) published a final rule amending the Quality Systems (QS) regulation for medical devices. The rule entered into force on 2 February…
EU Battery Regulation for medical devices and IVDs: manufacturers and producers
The EU Battery Regulation 2023/1542 is the legislative framework for all types of batteries in the European Union, whether sold separately, built-in, or supplied with…
Guidance on European Medical Device Nomenclature (EMDN)
The European Medical Device Nomenclature (EMDN) is the official and internationally recognised nomenclature for medical devices, as established under Regulation (EU) 2017/745 on medical devices…
Industry position on the proposed MDR and IVDR changes
In the last months, several EU organisations expressed their position on the proposed simplification of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics…