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…
UK Proposal to improve medical devices access in Great Britain
On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced a proposal to improve access to medical devices for patients in…
IVDR: 18th Notified Body on NANDO!
On 17 July 2025, the NANDO database listed a new Notified Body under the IVDR. POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. from Poland is the…
MDCG on timelines to implement Master UDI-DI
On 10 July 2025, the Medical Device Coordination Group (MDCG) released a position paper to clarify the timelines of the implementation of the Master UDI-DI…
Updated EU Regulation on electronic IFUs of medical devices
On 26 June 2025, the Official Journal of the EU published Commission Implementing Regulation (EU) 2025/1234. The Regulation amends Commission Implementing Regulation (EU) 2021/2226 published…
AI medical devices: how the AI Act impacts the MDR and IVDR
In June 2025, the MDCG published its sixth new guidance of the year: MDCG 2025-26. This document provides answers on certain aspects of the interplay…
New guidance on MDSW apps on online platforms
The Medical Device Coordination Group (MDCG) just published a new guidance on medical device software (MDSW) available on app platforms. Overall, more than one legislative…
Call for participation: joint clinical assessments of medical devices and EURLs
Today, 28 May, the European Commission published two important calls for stakeholders of the medical devices’ sector. The first published initiative is a call for…
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…
Team-NB on IVDR certification process, MDR technical documentation, and AI
On 14 April 2025, Team-NB – the European Association of Medical Devices Notified Bodies – published three position papers addressing different crucial aspects of medical…