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...
UK – Register medical devices to place on the market
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in...
Europe – Accord avec le Royaume-Uni relatif à la reconnaissance mutuelle en matière d’évaluation...
Depuis le retrait du Royaume-Uni de l’UE, l’accord entre la Suisse et l’UE relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité...
Europe – Lancement d’un groupe de travail européen sur l’évaluation des DM numériques (ANS)
PARIS (TICpharma) - Un groupe de travail européen sur l'évaluation des dispositifs médicaux (DM) numériques a débuté ses travaux en vue de "parvenir à...
Europe – European Notified Body survey: MDR, IVDR certification numbers remain low
A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification...
