Tag: Notified Body

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
News in Brief

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

April 17, 2026
News in Brief

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

April 10, 2026
News in Brief

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

April 3, 2026
News in Brief

Action required: IVDR class C legacy device deadlines are approaching

March 15, 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
Important Notice

Draft implementing regulation — notified body practices

December 19, 2025
News in Brief

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

November 21, 2025
News in Brief

TEAM NB issued revision 2 of IVDR best practice document

September 10, 2025
News in Brief

New CECP Scientific Opinion Published

July 10, 2025
News in Brief

Notified bodies caution about obstacles hindering their AI designation

June 16, 2025
News in Brief

News from Team-NB

May 4, 2025
News in Brief

Team NB has been updated its Code of Conduct

November 1, 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
Important Notice

Draft manufacturer self-declaration and notified body confirmation letter for Regulation (EU) 2024/1860 available

August 9, 2024
News in Brief

EU guidelines for justifying phthalates in medical devices updated

July 26, 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

Update of MDCG 2022-4

June 10, 2024
News in Brief

Manufacturers must act now to satisfy IVDR

December 4, 2023
News in Brief

Team-NB position papers on MDR and IVDR technical documentation

June 7, 2023
News in Brief

News on useful publications: MDCG borderline manual and bsi white paper on performance evaluations

October 13, 2022
News in Brief

Criticism on the EU’s 19-Point Regulatory Action Plan

October 11, 2022
MDR, News in Brief

bsi white paper on clinical evaluations

December 15, 2021
IVDR, MDR, News in Brief

MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services

October 4, 2021
MDR, News in Brief

bsi article on clinical evaluation requirements under the MDR

August 8, 2021
IVDR, News in Brief

EU IVD medical devices sector destined for crisis?

November 6, 2020
News in Brief

Update on Notified Bodies

March 4, 2020
News in Brief

DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR

November 6, 2019
News in Brief

New Notified Bodies Designated under the MDR and IVDR

October 15, 2019