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…
UK launches consultation on the indefinite recognition of CE-marked devices in Great Britain
The UK Government is running a targeted consultation on the possible indefinite recognition of CE‑marked medical devices on the Great Britain market. This initiative is…
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…