Author: Michael Sander

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
Important Notice

When is a medical device impacted by the AI Act?

August 6, 2024
News in Brief

EU guidelines for justifying phthalates in medical devices updated

July 26, 2024
Important Notice

AI Act published in OJEU

July 12, 2024
News in Brief

BSI first notified body to officially publish lead times under EU Medical Devices Regulations

June 14, 2024
Important Notice

European Parliament initiative for MDR improvement

June 12, 2024
News in Brief

Free scientific advice for high-risk devices

April 29, 2024
Brexit, News in Brief

UK-approved body capacity increases but not for IVDs

April 28, 2024
News in Brief

Could the AI Act result in the limited availability of medical technologies?

April 21, 2024
News in Brief

Request for scientific opinion on brain stimulators without a medical purpose

April 16, 2024
News in Brief

EU Artificial Intelligence Act final text agreed to by Parliament Committees

April 14, 2024
News in Brief

Availability swissdamed and new negotiations between the EU and Switzerland

April 5, 2024
Important Notice

European harmonised standards to be without charge

March 17, 2024
News in Brief

EU Data Act causes difficulties for medical device manufacturers

March 14, 2024