Author: Michael Sander

Important Notice

Commission expands “well-established technologies” list with two delegated acts

July 2, 2026
Important Notice

New harmonised standards published under MDR and IVDR — five-year grace period for the EC REP symbol

June 28, 2026
News in Brief

AI Act: Commission consults on transparency and high-risk classification guidelines

May 22, 2026
Important Notice

New EU Regulation on notified body conformity assessments published

May 12, 2026
News in Brief

New Team-NB position paper: Clinical evaluation under MDR article 61(10)

May 10, 2026
Important Notice

MDCG 2021-24 Rev.1, updated classification guidance published

April 29, 2026
News in Brief

EU AI Act: Parliament votes to delay high-risk rules

April 17, 2026
News in Brief

New harmonised standards for sterilizers and hearing aids listed under the MDR

April 12, 2026
News in Brief

Navigating supply interruptions: European Commission publishes revised Q&A on article 10a obligations

April 3, 2026
Important Notice

European Commission adopts two MDR amendments easing conformity assessment obligations

March 23, 2026
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
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