EUDAMED

EUDAMED Release notes 2026

EUDAMED

Release notes

Production 2.27.0
2026

Eudamed Released Notes 2026

EUDAMED user guide

UDI Devices

Production v 2.27.0
2026

EU Regulatory Documents

MedTech Europe has released “An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?” — a supplement to its position on the revision of the MDR and IVDR.
EXPERT OPINION on Proposed Article 50 MDR of the Commission’s Proposal Amending the MDR and IVDR

EXPERT OPINION

on Proposed Article 50 MDR of the Commission’s Proposal Amending the MDR and IVDR
The Information obligarion
The information obligation in case of interruption or dicontinuation of supply of certain medical devices and In Vitro diagnostic medical devices
MD/IVD targeted revision of EU rules “Have your say”

MD/IVD targeted revision of EU rules “Have your say”

Adoption date: 07/04/2026

Swiss Regulatory Documents

Technical document

swissdamed Business Rules

02.05.2026

Guidance document CH Guide Manufacturer Incident Report (MIR)

Guidance document

CH Guide Manufacturer Incident Report (MIR)

01.05.2026

Information sheet Medical Device Software

Information sheet

Medical Device Software

21.04.2026

Information sheet 3D printers medical devices

Information sheet

3D printers medical devices

26.03.2026

UK Regulatory Documents

Australian Regulatory Documents