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…
EU pilot programme to support breakthrough medical devices and in vitro diagnostics
The European Medicines Agency (EMA) launched a pilot programme to support breakthrough medical devices and diagnostics with a significant positive clinical impact. This initiative aims…
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…
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…
New harmonised standards under the MDR and IVDR
On 30 January 2026, the Official Journal of the European Union published two new Implementing Decisions. Commission Implementing Decision (EU) 2026/193 and Commission Implementing Decision…
Q&A on Proposal to simplify the EU Medical Devices Regulations
The EU’s Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) Regulations were introduced to strengthen public health protection and patient safety. However, a recent…
New MDCG guidance on post-market surveillance
In December 2025, the Medical Device Coordination Group (MDCG) released a new guidance on post-market surveillance of medical devices and IVDs on the Union market.…