Author: Oliver Giesemann

News in Brief

Swissmedic confirms swissdamed registration fees

June 3, 2026
News in Brief

EU unlocks new funding for health AI projects

May 26, 2026
News in Brief

New EUDAMED version released

May 23, 2026
News in Brief

Provisional agreement on EU Digital Omnibus on AI

May 9, 2026
Important Notice

EUDAMED training 2026 – key opportunity for all medical device stakeholders

May 8, 2026
News in Brief

Switzerland–EU MRA: Momentum returns, but a long way to go

May 3, 2026
News in Brief

Update Alert from the European Commission – borderline products, EMDN codes, MIR status and clinical investigations/ performance studies

May 2, 2026
News in Brief

New CECP opinion published: Expert panel backs extended indication for cardiac pacing lead

April 10, 2026
News in Brief

Recording now available: Commission high level conference on MDR/IVDR revision

April 2, 2026
Important Notice

Updated MIR form v7.3.1: Mandatory from 1 May 2026

March 31, 2026
News in Brief

Action required: IVDR class C legacy device deadlines are approaching

March 15, 2026
News in Brief

European Commission hosts conference on medical devices in March

February 5, 2026
Important Notice

Draft implementing regulation — notified body practices

December 19, 2025
Important Notice

The EUDAMED first four modules will be mandatory to use as from 28 May 2026

December 17, 2025
News in Brief

News from the European Commission

December 9, 2025
News in Brief

Team-NB position paper — When companion-diagnostic changes require notified-body approval

November 21, 2025
News in Brief

Clinical evidence requirements under the IVDR — MedTech Europe eBook

October 8, 2025
News in Brief

EU4Health supports orphan devices and SMEs

September 17, 2025
News in Brief

New Revision: MDCG 2024-14 Rev. 1 on Master UDI-DI for Contact Lenses

September 14, 2025
News in Brief

The European Commission published MDCG 2025-7 on the use of a Master UDI-DI for certain optical devices

August 3, 2025
News in Brief

General-Purpose AI Code of Practice published

July 15, 2025
Important Notice

Electronic Instructions for Use (eIFU) for Professional Use Medical Devices

July 9, 2025
Important Notice

Guidance on EU MDR/ IVDR and AI Act interplay

July 8, 2025
Important Notice

New MIR Form 7.3.1 Now Accepted in Switzerland

June 2, 2025
News in Brief

European Medical Devices Nomenclature (EMDN) helpdesk is live!

May 31, 2025
Important Notice

European Commission publishes updated version of the Manufacturer Incident Report (MIR)

May 7, 2025
Important Notice

EUDAMED Workshop – Preparing for Compliance

April 8, 2025
Important Notice

Upcoming UDI labeling requirements for Medical Devices

April 7, 2025
Important Notice

Update to MDCG Guidelines for In Vitro Diagnostics

April 4, 2025
News in Brief

New and updated guidance for the MDR and IVDR

March 15, 2025
News in Brief

EU policymakers to retract the proposal on AI liability

March 8, 2025
Important Notice

EC REP to EU REP: A new symbol for European Authorized Representatives

February 14, 2025
Important Notice

Guidance on SARS-CoV-2 test classification and news on EMDN coding

February 6, 2025