MHRA publishes new PSUR format
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,…
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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…
Guidance on UDI carrier obligation: requirements, implementation, exceptions
The Unique Device Identification (UDI) system under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) provides for enhanced traceability,…
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!
Since the 1st of May 2025, the NANDO database has a new Notified Body under the IVDR! DNV Product Assurance from Norway is the 17th EU…
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…
IVDR: 15th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. is the 15th EU Notified Body…
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