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…
New harmonised standards for medical devices and IVDs
On 9 and 10 April 2025, the Official Journal of the EU published references to standards for medical devices. The standards address conformity of medical…