As of 7 October 2025, the NANDO database includes NOTICE as a notified body, which brings the total number of notified bodies under Regulation (EU)…
Master UDI-DI for spectacle frames and lenses
On 23 September 2025, the Official Journal of the EU published Commission Delegated Regulation (EU) 2025/1920. This Regulation amends Part C of Annex VI of…
MedTech Europe on simplification of EU digital legislation and State of the Union Address
MedTech Europe recently published two position papers on the latest development on strength, resilience, and competitiveness policies in the medical technology sector. With the first…
Call for evidence on the targeted revision of EU MDR & IVDR
On 8 September 2025, the European Commission launched a Call for Evidence on the targeted revision of the EU rules for medical devices (MDR) and…
EUDAMED: timeline as of August 2025
This summer, the European Commission was expected to announce the functionality of five EUDAMED modules. With this announcement, Actor, UDI/Devices, notified body/certificates as well as…
MedTech Europe calls for aligned implementation of AI Act with MDR & IVDR
In its press release, published on 1 August 2025, marking one year since the entry into force of the Artificial Intelligence (AI) Act, MedTech Europe…
New Manufacturer Incident Report (MIR) form in EU
On 5 May 2025, the European Commission released an updated version of the Manufacturer Incident Report (MIR) form (version 7.3.1). This version will become mandatory…
2025 deadlines for medtech in the EU, UK, and Switzerland
2025 brings crucial regulatory deadlines for the medtech sector across the EU, UK, and Switzerland. Some of the key dates and requirements that a manufacturer…
Initiatives to reform MDR and IVDR
Since the Medical Devices Regulation (MDR) and the In-vitro Medical Device Regulation (IVDR) came into full force, several individuals and associations have raised concerns regarding…
New Product Liability Directive (PLD): What is changing?
On 18 November 2024, Directive (EU) 2024/2853 on liability for defective products (new PLD) was published in the Official Journal of the EU. The new…