Tag: Notified Body

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
News in Brief

News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices

September 4, 2019
News in Brief

LRQA to Withdraw Notified Body Services

June 13, 2019
News in Brief

Quality Assurance Agreements (QAA)

June 11, 2019
News in Brief

Spain’s Only Notified Body Not Accepting Applications for Certification of New Products

June 3, 2019
News in Brief

EU Authorities Might Review Products in Case of Notified Body (NB) Shortage

May 20, 2019
CE Consulting, IVDR, MDR

Notified Body Selection and Change

December 15, 2018