News

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

7/11/2022

This Joint Implementation Plan is the result of review by the MDCG including the relevant sub-groups, with input from stakeholders. It has been endorsed in principle in the MDCG meeting of 28 May 20...

MDCG 2022 16

2/11/2022

MDCG issued a guidance for EU ARs under MDR and IVDR

Notified bodies survey on certifications and applications

27/10/2022

Interesting facts and updates for MDR IVDR

MedTech Cyber Security in EU

11/10/2022

Team NB publishes position paper

SEHTA 2022 International MedTech Expo & Conference

10/10/2022

Meet Our Expert at SEHTA 2022 International MedTech Expo & Conference

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.

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