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.…
EU MDR and IVDR targeted revision consultation now open
The European Commission is collecting feedback on the proposed targeted MDR and IVDR revision. Stakeholders can submit their views from 7 January until 6 May…
MDR: 52nd notified body on NANDO
On 24 December 2025, Malta Conformity Assessment Ltd. was added to the NANDO database as a notified body for the Medical Devices Regulation (EU) 2017/745…
Commission publishes a Proposal for a Regulation to simplify MDR and IVDR
On 16 December 2025, the European Commission published a proposal for a Regulation to reduce and simplify rules on medical and in vitro diagnostic devices.…
EUDAMED timeline: actor and device registration
With the EUDAMED notice published on 27 November 2025, the European database becomes officially mandatory. While the database has six modules, the four following modules…