{"id":1348,"date":"2022-06-28T15:50:44","date_gmt":"2022-06-28T14:50:44","guid":{"rendered":"https:\/\/mybraintech.com\/?p=1348"},"modified":"2023-05-26T01:34:04","modified_gmt":"2023-05-25T23:34:04","slug":"mybrain-technologiess-eye-on-medical-device-regulation","status":"publish","type":"post","link":"https:\/\/emmanuel-guerin.fr\/dev-mybraintech\/2022\/06\/28\/mybrain-technologiess-eye-on-medical-device-regulation\/","title":{"rendered":"myBrain Technologies’s eye on Medical Device Regulation."},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\r\n

With Sophie Colliot,<\/mark>
Chief Quality Officer at myBrain Technologies.<\/mark><\/p>\r\n\r\n\r\n

\r\n
\"\"<\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n\r\n

Nowadays, everyone is aware of the importance of new technologies in all sectors of society, and particularly AI systems. If there is one sector in which AI systems are creating a major upheaval, it is the health and Medical Devices (MD) sector.<\/em><\/p>\r\n\r\n\r\n\r\n

Although AI-based systems are growing considerably, they are still relatively new and their functioning is still not well known by users, hence a certain scepticism about the performance and safety of these devices.<\/em><\/p>\r\n\r\n\r\n\r\n

The role of regulations, which have recently evolved, is to ensure the safety of users in order to reassure them and thus facilitate the adoption of these technologies. The difficulties faced by manufacturers to bring their Medical Devices to market, while complying with the new regulatory requirements, can legitimately worry these players. However, there are strategies that can help them acquire the necessary certification to bring their products to market.<\/em><\/p>\r\n\r\n\r\n\r\n

Indeed, with the aim of reinforcing health safety and harmonizing the application of the rules within the European Union, an in-depth revision of the regulations led to the publication in the Official Journal of the European Union, on May 5, 2017, of a new regulation specific to medical devices (MDR 2017\/745). This regulation has been in application since May 26, 2021, the date having been postponed by one year by decision of the European Parliament in the context of the COVID-19 health crisis.<\/em><\/p>\r\n\r\n\r\n\r\n

The implementation of MDR 2017\/745 results in the invalidity of certificates issued under the Directives as of May 27, 2024 and the end of placing in service or making available of MD placed on the market under these directives.<\/em><\/p>\r\n\r\n\r\n\r\n

To understand the difficulties of its application by manufacturers and to find solutions, we interviewed Sophie Colliot, Chief Quality Officer at myBrain Technologies.<\/em><\/p>\r\n\r\n\r\n

\r\n\r\n\r\n

Interviewer (I):<\/em> To begin, can you tell us who is affected by the arrival of AI systems in the Medical Devices sector?\u00a0<\/strong><\/p>\r\n\r\n\r\n\r\n

Sophie Colliot (SC): <\/em>Hello. Three categories of users are affected by this upheaval.<\/p>\r\n\r\n\r\n\r\n