The MHRA, the UK Medicines and Healthcare products Regulatory Agency, released a new standardised format for the periodic safety update report (PSUR). Dated June 2025,…
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 MDCG Guidance on performance studies of IVDs
In June 2025, the Medical Device Coordination Group (MDCG) published a new guidance document on performance studies of in vitro diagnostic medical devices under Regulation…
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…
MHRA guidance on new UK PMS Regulations
The Medical Devices Post-market Surveillance Requirements Regulations 2024 amends the UK Medical Devices Regulations (MDR) 2002 and includes a new section on post-market surveillance (PMS)…
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…
IVDR: 17th Notified Body on NANDO!
On 1 May 2025, the NANDO database listed a new Notified Body under the IVDR. DNV Product Assurance from Norway is the 17th EU Notified…
IVDR: 16th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! SGS Belgium is the 16th EU Notified Body notified under the Regulation (EU) 2017/746…