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

August 5, 2021
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May 29, 2021
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Free intended use generator – an important tool under the MDR

September 16, 2021
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bsi article on clinical evaluation requirements under the MDR

August 8, 2021
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Team-NB publishes position paper on the applicability of MDR implant card requirements

August 1, 2021
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New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR

July 4, 2021
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Insufficient sterilization of medical devices by Steril Milano S.r.l

June 28, 2021
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
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Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN

June 15, 2021

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January 17, 2021

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October 26, 2020

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September 17, 2020

Brexit and the regulatory situation for the medtech industry

February 3, 2020

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October 29, 2019

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September 26, 2019

United Kingdom (UK) to Request ‘UK Responsible Person’

August 19, 2019

Details about the Regulation of Medical Devices in Case of No-Deal Brexit

February 28, 2019

News in Brief

bsi article on clinical evaluation requirements under the MDR

August 8, 2021

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

August 5, 2021

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

August 1, 2021

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mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
MDR, Network

Free intended use generator – an important tool under the MDR

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

September 16, 2021
CE Marking, Download Section Service, Guidance Documents, IVDR Service, Legislation Documents, Library, MDR Service

Complete Download Section mdi Europa

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

August 16, 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
Important Notice, News in Brief

Insufficient sterilization of medical devices by Steril Milano S.r.l

The Federal Institute for Dugs and Medical Devices (BfArM) in Germany has issued a notice where it informs manufacturers and users about the inadequate sterilization of medical devices by Steril… Read More

June 28, 2021
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
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

The Medical Device Coordination Group (MDCG) has issued new guidance documents under Regulation (EU) 2017/745 on medical devices (MDR): MDCG 2021-08 lays out application mechanisms including application forms for clinical… Read More

June 15, 2021
IVDR, MDR, News in Brief

EU UDI helpdesk available

Just recently, the European Commission launched a new helpdesk website for EU UDI related questions under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices… Read More

June 10, 2021

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