Europe – MDCG 2022-4 Rev.1 Guidance on appropriate surveillance regarding the transitional provisions under...
Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that
devices which are covered by valid certificates issued by a notified...
Europe – MDCG 2022-21 Guidance on periodic safety update report (PSUR) according to regulation...
The Periodic Safety Update Report (PSUR) has been introduced in Article 86 of the Medical
Device Regulation (MDR) 2017/745. The introduction of the PSUR requirement...
Europe – MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
The sponsor of a performance study is required to submit an application/notification1 to the Member State(s) in which a performance study is to be...
Europe – EU issues implementing regs for devices without an intended medical purpose
Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices...
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 – European Council members support proposal to delay MDR deadlines
European Council members expressed support for a proposal by the European Commission to delay the transitional deadlines for medical devices under the Medical Devices...
Europe – MDCG 2022-17 – MDCG position paper on ‘hybrid audits’
This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745...
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 – Artificial Intelligence Act : un nouveau règlement européen à suivre de près
L’AIA est une proposition de règlement du parlement et du conseil européens dévoilée le 21 avril 2021, dont l'entrée en vigueur est programmée dans...
UK – Borderline products: how to tell if your product is a medical device...
Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal...
