Author: Michael Sander

News in Brief

AI Act provisions for general-purpose AI apply

August 14, 2025
News in Brief

European Commission publishes template for summary of training data

August 7, 2025
News in Brief

EU pilot for all-in-one regulatory pathway for drug and diagnostic trials

July 23, 2025
News in Brief

Implementing Decision (EU) 2025/1324 on Expert Panels for Orphan Devices

July 11, 2025
News in Brief

New CECP Scientific Opinion Published

July 10, 2025
Important Notice

MDCG published guidance 2025-6

July 8, 2025
News in Brief

MDCG 2019-11 rev. 1 published by the European Commission

July 1, 2025
News in Brief

New Q&A Guidance: MDCG 2025-5 on IVDR Performance Studies

June 25, 2025
News in Brief

New MDCG Guidance Alert

June 25, 2025
News in Brief

Notified bodies caution about obstacles hindering their AI designation

June 16, 2025
News in Brief

Unlocking AI Literacy: What You Need to Know

June 7, 2025
Important Notice

More standards under MDR and IVDR harmonized

May 5, 2025
News in Brief

News from Team-NB

May 4, 2025
News in Brief

Sponsors are now invited to apply for the EU’s pilot programme aimed at expediting clinical investigations and performance studies

March 22, 2025
News in Brief

Non-EU medical technology companies could encounter lawsuits due to revised product liability directive

March 6, 2025
News in Brief

Industry and policymakers push for medical technology regulatory reforms in the EU

February 12, 2025
News in Brief

Medtech companies facing risk of non-compliance as EU AI deadlines approach

February 3, 2025
News in Brief

Swissmedic launches a initiative on post-market surveillance

February 1, 2025
News in Brief

Switzerland moves closer to regulatory progress in medical technology

February 1, 2025
Important Notice

mdi Europa expands services

January 22, 2025
Important Notice

Meet mdi Europa at Arab Health 2025

January 15, 2025
News in Brief

Medical technology industry calls for urgent EU action

December 18, 2024
Important Notice

MDCG Q&A document on vigilance updated

December 2, 2024
News in Brief

TEAM NB published questionnaire on AI in medical devices

December 1, 2024
News in Brief

Council of the European Union proposes key elements for MDR/ IVDR reform

November 29, 2024
News in Brief

Team NB has been updated its Code of Conduct

November 1, 2024
News in Brief

Practical PMCF strategies and plans

October 28, 2024
News in Brief

EU on proposed regulations for seven high-risk IVD test categories

October 2, 2024
News in Brief

TEAM-NB position paper on IVDR transfer agreement for surveillance

September 26, 2024
Important Notice

MDR extended transition period and notified body agreement

September 26, 2024
News in Brief

EU launches call for regulatory medical technology innovation sandbox

September 12, 2024
Important Notice

The medical technology sector faces significant changes due to the EU’s upcoming PFAS restriction

September 9, 2024
News in Brief

The EU’s standardisation guidance MDCG 2021-5 has been updated

August 14, 2024