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MDCG 2022 15

23/9/2022

Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

Manual on Borderline

13/9/2022

Borderline cases are those for which it is not clear from the outset whether a given product is a medical device, or an in vitro diagnostic medical device (IVD), or not.

MDCG 2022 14

26/8/2022

MDCG position Paper – Transition to the MDR and IVDR

IVDR Update related to EUDAMED

14/7/2022

MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

Funding competition Fast Start Innovation

12/7/2022

UK registered small and micro businesses can apply for a share of up to £30 million for affordable, adoptable and investable innovations in net zero and Healthcare.

EUDAMED Timeline

7/7/2022

Quite Recently, The European Commission published the timeline of when will this system be in place, functional and enforced for mandatory use.

laying down common specifications for certain class D in vitro diagnostic medical devices

4/7/2022

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 o...

MDD Turns 3

1/7/2022

Happy Birthday to ME!!

Government Publishes Consultation Response on the Future Regulation of Medical Devices in the UK

27/6/2022

Government Publishes Consultation Response on the Future Regulation of Medical Devices in the UK.

MDCG 2022-11

13/6/2022

MDCG issues notice to Manufacturers.

Quality Management Workshop Codex4SMES

30/5/2022

There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requ...

Economic Operators Workshop Codex4SMES

30/5/2022

There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requ...

Workshop for SMEs

30/5/2022

The Codex4SMEs project provides diagnostics SMEs from North-West Europe with various workshops free of charge, conducted by experts from the network. Med-Di-Dia provides a choice of two different work...

Welcoming IVDR

26/5/2022

Med-Di-Dia Welcomes In-Vitro Diagnostic Regulations #IVDR #IVDRReady

Summary of safety and performance Template – MDCG 2022-9

25/5/2022

MCDG Published a template for summarising the safety and performance requirements.

Questions and Answers on the Unique Device Identification system

23/5/2022

MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG Guidance 2022-8

20/5/2022

MDCG Publishes Guidance on Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Direc...

MDCG Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.

4/5/2022

In order to benefit from the transition periods provided in Article 110(3) IVDR, devices may not undergo any significant change in the design or intended purpose after the date of application of the I...

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

26/4/2022

This report highlights the updates from the implementation of Medical Device Regulations – MDR and upcoming In-Vitro Diagnostic Regulations – IVDR.

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