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October 7, 2021
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August 5, 2021
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Guidance document on the impact of genetic variants on SARS-COV-2

May 29, 2021

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November 12, 2021
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November 10, 2021
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Extended IVDR transition period for certain IVD medical devices

October 25, 2021
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Free intended use generator – an important tool under the MDR and IVDR

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

New European Commission guidance document on MDR medical device classification

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

EUDAMED UDI/Devices and NBs/Certificates modules now live

October 6, 2021

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January 17, 2021

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October 26, 2020

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September 17, 2020

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February 3, 2020

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October 29, 2019

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September 26, 2019

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August 19, 2019

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

February 28, 2019

News in Brief

The MDR is now fully applicable – but it means not the end of the world

November 15, 2021

New guidance on legacy devices published

November 12, 2021

IEC about to publish new standard on cybersecurity

November 10, 2021

News In Brief

MDR, News in Brief

New guidance on legacy devices published

The Medical Device Coordination Group (MDCG) has issued another guidance document, MDCG 2021-25. The document provides further guidance on certain open questions around how Regulation (EU) 2017/745 on medical devices… Read More

November 12, 2021
IVDR, MDR, News in Brief

IEC about to publish new standard on cybersecurity

The International Electrotechnical Commission (IEC) plans to issue the new cybersecurity standard IEC 81001-5-1 soon. It deals with how IT security must be considered in the software life cycle. As… Read More

November 10, 2021
Important Notice, IVDR

Extended IVDR transition period for certain IVD medical devices

The European Commission has given in and makes concessions to the industry. On October 14, 2021 the Commission issued the corresponding proposal for a partial delay of Regulation (EU) 2017/746… Read More

October 25, 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

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

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S. Mittal · Mediplus (India) Ltd.

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