Public consultation launched: EU Commission seeks feedback on reform of MDR and IVDR
The EC launched a public consultation on the reform of the MDR and IVDR. Comments can be submitted by 4 March 2026.
MDCG publishes new guideline on post-market surveillance
MDCG publishes MDCG 2025-10 guideline on post-market surveillance for medical devices and in vitro diagnostic medical devices.
MDCG releases guidance on breakthrough devices
MDCG releases guidance on breakthrough devices aims to support the development, conformity assessment, and market access of breakthrough medical devices (BtMD) and in vitro diagnostic devices (BtIVD), thereby ensuring high safety and clinical evidence standards.
EUDAMED: First four modules confirmed operational
On 27 November 2025, the EC published Decision (EU) 2025/2371, confirming the functionality of specific electronic systems within the European Database for Medical Devices (EUDAMED).
New ISO 10993-1:2025 Standard for Medical Device Biological Evaluation Released
New MD biocompatibility standard, ISO 10993-1:2025, helps manufacturers identify, assess, and manage biological risks associated with materials, design choices, and tissue contact during a device’s intended use.
Let’s meet at MEDICA-COMPAMED 2025
Let’s meet at MEDICA-COMPAMED 2025 in Dusseldorf from 17-20 November
Updated Manual on Borderline and Classification for Medical Devices Released
The fourth version of the ‘Manual on Borderline and Classification for Medical Devices under Regulations (EU) 2017/745 and (EU) 2017/746’ was published on 12 September 2025.
Future restrictions on PFAS and current regulatory activities from FDA and EU REACH
PFAS in medical devices, typically large-molecule materials known as fluoropolymers, garnered significant public attention due to concerns about their potential impact on human health and/or the environment.
MDCG and AIB release guidance on interplay between EU MDR/IVDR and AI Act
MDCG 2025-6 and AIB 2025-1, released on June 19, 2025, and setting out the interplay between EU MDR/IVDR and AI Act.
European Commission releases updated MDCG 2019-11 guidance on software qualification and classification under MDR and IVDR
EU updates MDCG 2019-11 guidance on qualification and classification of medical device software
