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October 11, 2021
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MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services

October 4, 2021
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Team-NB publishes position paper on the applicability of MDR implant card requirements

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February 28, 2019

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Free intended use generator – an important tool under the MDR and IVDR

October 15, 2021

New European Commission guidance document on MDR medical device classification

October 11, 2021

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The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find more than 50 important… Read More

October 19, 2021
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
IVDR, MDR, Network, News in Brief

Free intended use generator – an important tool under the MDR and IVDR

The intended use statement of medical devices is a central aspect in the European regulatory environment. The intended use drives the requirements a device must fulfill. This has already been… Read More

October 15, 2021
Important Notice, MDR, News in Brief

New European Commission guidance document on MDR medical device classification

The European Commission has put another item on its already long list of guidance documents for medical device manufacturers. MDCG 2021-24, Guidance on classification of medical devices, will probably be… Read More

October 11, 2021
Important Notice, IVDR, MDR, News in Brief

EUDAMED UDI/Devices and NBs/Certificates modules now live

The European Commission has announced recently that the EUDAMED UDI/Devices and NBs and Certificates modules are now ready. Specifically, the UDI/Devices module is probably of interest for many manufacturers as… Read More

October 6, 2021
IVDR, MDR, News in Brief

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

Back in 2019, the Medical Device Coordination Group (MDCG) published guidance MDCG 2019-6, a Q&A document related to requirements around notified bodies. The Commission has now issued revision 3 of… Read More

October 4, 2021
MDR, News in Brief

bsi article on clinical evaluation requirements under the MDR

Notified body bsi has published an article in February in the Journal of Medical Device Regulation. In this article, bsi is sharing insights on its perspective on how manufacturers should… Read More

August 8, 2021
MDR, News in Brief

Team-NB publishes position paper on the applicability of MDR implant card requirements

Team-NB, the European Medical Devices Notified Body Association, published a position paper on the applicability of implant cards as required under Regulation (EU) 2017/745 on medical devices (MDR). Readers should… Read More

August 1, 2021
IVDR, MDR, News in Brief

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

The Medical Device Coordination Group (MDCG) has issued another guidance document. MDCG 2021-10 references certain principles and terminology used in appendices E – I of the IMDRF N48 guidance document… Read More

July 4, 2021

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