Author: Michael Sander

News in Brief

Team-NB sets out expectations for combinatorial IVD medical device claims

March 11, 2026
News in Brief

EU regulatory overhaul sparks debate

March 8, 2026
News in Brief

New set of harmonized standards published

January 30, 2026
Important Notice

MDCG 2025-10 — Guidance on post-market surveillance – manufacturers should review PMS documents

January 2, 2026
News in Brief

MDCG 2025-9 — Guidance on breakthrough devices (BtX)

December 23, 2025
Important Notice

EU MDR & IVDR reform: what manufacturers need to know

December 16, 2025
News in Brief

Draft standard on clinical evaluation published

December 3, 2025
News in Brief

ISO 10993-1:2025 published

December 1, 2025
Important Notice

MDCG Q&A — trend reporting

October 6, 2025
News in Brief

Manual on Borderline and Classification under the MDR and IVDR updated

October 1, 2025
News in Brief

EN IEC 61326-2-6 was updated

September 28, 2025
News in Brief

TEAM NB issued revision 2 of IVDR best practice document

September 10, 2025
News in Brief

EU launches consultation to develop guidelines and Code of Practice on transparent AI

September 5, 2025
Important Notice

Targeted revision: MDR & IVDR — Have your say

September 5, 2025
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
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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