UK – MHRA launches public consultation on future of medical device regulation
Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences...
USA – Switzerland eyes allowing FDA-approved medical devices onto its market
The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators,...
Europe – MDCG 2022-18 : Position Paper on the application of Article 97 MDR...
In accordance with Article 5 of Regulation (EU) 2017/745 on medical devices (MDR),
a device may be placed on the market only if it complies...
Europe – MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical...
This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on
clinical trials for medicinal products for human use (CTR) and Regulation...
Europe – MDCG 2021-4 Application of transitional provisions for certification of class D in...
According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic...
Europe – Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro...
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...
UK – MHRA launches public consultation on future of medical device regulation
Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences...
Europe – Publication of the Third Edition of the “Clinical Evidence Requirements under EU...
We are pleased to announce the publication of the Third Edition of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” Regulatory eBook.
The Questions and Answers eBook was developed by...
Europe – MDCG 2021-6 : Regulation (EU) 2017/745 – Questions & Answers regarding clinical...
Regulation (EU) 2017/745 (MDR) will progressively replace both Directives (93/42/EEC and
90/385/EEC) and their transpositions in national law.
The first difference is regarding the type of...
Europe – MDCG 2022-14 – Transition to the MDR and IVDR – Notified body...
The MDCG recognises that significant and urgent challenges remain in ensuring sufficient
capacity of notified bodies and readiness of manufacturers in order to allow medical...
