On Friday 17 October, the European Commission adopted an implementing regulation laying down detailed rules for the joint clinical assessments of medical devices and in vitro diagnostic medical devices. This text stems from Regulation 2021/2282 on health technology assessment.
The new regulation sets out the procedure for joint assessments, specifying: - cooperation between the Member States’ coordination group, the Commission, the notified bodies and the expert panels; - interactions with health technology developers, patients, clinical experts and other stakeholders; - the procedures for selecting and consulting the organisations and individual experts involved in the process.
This text is the sixth and final implementing regulation needed to ensure the full application of Regulation 2021/2282.
According to the Commission, nine joint clinical assessments are already underway, focusing in particular on anti-cancer medicines and advanced therapy products.
Link to the text published in the Official Journal of the EU: https://aeur.eu/f/j1r (Original version in French by Lionel Changeur)