Author: Oliver Giesemann

News in Brief

MDCG published guidance on EMDN code updates and clinical investigation plans

March 13, 2024
News in Brief

Potential applicability of Regulation (EU) 2023/1115

March 12, 2024
Important Notice

Extension of IVDR transition periods and early launch of Eudamed in the pipeline

February 7, 2024
News in Brief

Update to MDCG 2021-27 on importer and distributor roles

January 12, 2024
News in Brief

AI significant in October regulatory discussions

December 1, 2023
News in Brief

EU rules for device software working with hardware

November 29, 2023
Important Notice

EU medical device industry faces further delays related to EUDAMED

November 7, 2023
News in Brief

Harmonization of MDR and IVDR standards still slow

August 14, 2023
COVID-19, News in Brief

COVID-19 tests and their risk classification

August 2, 2023
Important Notice

EU AI Act approved by Parliament

July 3, 2023
News in Brief

Spain brings in additional national requirements

May 27, 2023
Important Notice

Registering a legacy device in Eudamed is a good step

May 12, 2023
News in Brief

UDI helpdesk website published

April 13, 2023
News in Brief

News on guidance documents

March 3, 2023
News in Brief

EU notified bodies on harmonised standards regarding cybersecurity

January 6, 2023
News in Brief

Cybersecurity in the EU

November 8, 2022
Important Notice

Different options for IVD medical devices until Eudamed becomes fully operational

September 2, 2022
Important Notice, IVDR, MDR

Updated Blue Guide and MDR and IVDR harmonized standards

July 14, 2022
MDR, News in Brief

CAMD working group publishes Q&A document regarding FSCs

July 11, 2022
Important Notice, IVDR, MDR

EUDAMED update on timelines

April 10, 2022
News in Brief

New cybersecurity standard

April 2, 2022
Important Notice, IVDR

IVD medical devices after the IVDR date of application

March 12, 2022
IVDR, News in Brief

New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices

March 4, 2022
COVID-19, News in Brief

New guidance for third-country manufacturers of COVID-19 IVD tests

February 6, 2022
Important Notice, IVDR, MDR

European Commission EUDAMED website expanded

December 6, 2021
IVDR, MDR, News in Brief

IEC about to publish new standard on cybersecurity

November 10, 2021
COVID-19

SARS-CoV-2 IVD tests and the IVDR

October 7, 2021
Important Notice, IVDR, MDR

EUDAMED UDI/Devices and NBs/Certificates modules now live

October 6, 2021
IVDR, MDR, News in Brief

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

October 4, 2021
COVID-19, News in Brief

The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD

August 5, 2021
IVDR, MDR, News in Brief

New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR

July 4, 2021
IVDR, MDR, News in Brief

Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN

June 15, 2021
IVDR, MDR, News in Brief

EU UDI helpdesk available

June 10, 2021