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...
USA – FDA proposes framework for human factors information in device submissions
The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included...
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...
USA – FDA aims to clarify device malfunction summary reporting requirements
In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction...
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,...
International – Medical devices 2030 : Making a power play to avoid the commodity...
The days of simply manufacturing a device, and selling it to healthcare providers via distributors, have long vanished. Value is the new byword for...
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...
France – Études en vie réelle – Recensement des sources de données mobilisables pour...
Les données en vie réelle ont pris une place majeure dans l’évaluation des produits de santé contribuant aux avis de la HAS tout au...
