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Common Specifications for Borderline Medical Devices in EU

Common Specifications for Borderline Medical Devices in EU

5/12/2022

On December 01, 2022, the European Commission published Document C(2022)8626 - laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to R...
List of Common Specifications under Annex XVI – EU MDR

List of Common Specifications under Annex XVI – EU MDR

5/12/2022

EU MDR is getting serious. Dead Serious!
Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

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

MDCG 2022 16

2/11/2022

MDCG issued a guidance for EU ARs under MDR and IVDR
Notified bodies survey on certifications and applications

Notified bodies survey on certifications and applications

27/10/2022

Interesting facts and updates for MDR IVDR
MedTech Cyber Security in EU

MedTech Cyber Security in EU

11/10/2022

Team NB publishes position paper
SEHTA 2022 International MedTech Expo & Conference

SEHTA 2022 International MedTech Expo & Conference

10/10/2022

Meet Our Expert at SEHTA 2022 International MedTech Expo & Conference
MDCG 2022 15

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

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

MDCG 2022 14

26/8/2022

MDCG position Paper – Transition to the MDR and IVDR
IVDR Update related to EUDAMED

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

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

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

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

MDD Turns 3

1/7/2022

Happy Birthday to ME!!
Government Publishes Consultation Response on the Future Regulation of Medical Devices in the UK

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

MDCG 2022-11

13/6/2022

MDCG issues notice to Manufacturers.
Quality Management Workshop Codex4SMES

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

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

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...

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