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EUMDR Transitional Provisions – Deep Dive


Certain Medical Devices have the advantage of an extended transitional period!

EU MDR Timeline


Extension of EU MDR Transitional Timelines

MDCG 2020-16 Rev 2


Here are some key points that medical device manufacturers should keep in mind from MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under IVDR.

MDCG 2023-3 Guidance


Quick Summary to MDCG 2023 - 3 Guidance

Best Medical Regulatory & Quality Compliance Consultancy


Awards and recognitions motivate us to work more efficiently!

MedTech Regulatory Updates in EU


Find all the Regulatory Updates for Medical Devices, Diagnostics and Digital Health in EU!

Common Specifications for Borderline Medical Devices in EU


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


EU MDR is getting serious. Dead Serious!

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


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 issued a guidance for EU ARs under MDR and IVDR

Notified bodies survey on certifications and applications


Interesting facts and updates for MDR IVDR

MedTech Cyber Security in EU


Team NB publishes position paper

SEHTA 2022 International MedTech Expo & Conference


Meet Our Expert at SEHTA 2022 International MedTech Expo & Conference

MDCG 2022 15


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


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 position Paper – Transition to the MDR and IVDR

IVDR Update related to EUDAMED


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


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


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


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...

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