European medical device regulations
Information
Type
Miscellaneous
Regulated products
IVDMD, Medical Devices
Topics
Medical Device Industry
Last updated
December 12, 2023
Description
Medical device sector is of great importance in healthcare in Europe, contributing to the improvement of the level of health protection through the development of innovative solutions for diagnosis, prevention, treatment and rehabilitation. Since the early 2020s, due to the SARS-CoV-2 pandemic, the medical device and in vitro diagnostic medical device sector has been particularly involved, both in terms of the sudden increase in need and because of the need for innovative interventions to counter the spread of the pandemic. Regulation (EU) 2017/745 and Regulation (EU) 2017/746 amended the rules governing the system of medical devices and in vitro diagnostic medical devices, taking into account the developments in the sector over the past two decades, with the aim of ensuring a robust, sustainable regulatory framework with transparent procedures and suitable for maintaining a high level of safety , while encouraging 'innovation . The regulations were published in the Official Journal of the European Union on May 5, 2017, and both entered into force 20 days after their publication. The need to amend the sector regulations stems from the need to ensure, including through increasing harmonization, the proper functioning of the internal market within the European Union, while raising product quality and safety standards in the context of a state-of-the-art, innovation-friendly legislative framework that places the EU as the guarantor of public health and patient health and safety with reference to the medical device sector. The regulations represent a significant step forward from the past and a strengthening of the existing regulatory system for medical devices in Europe. They will, through a gradual process requiring national transitional solutions that are not incompatible with European provisions, gradually replace Directives 93/42/EEC, 90/385/EC and 98/79/EC that have been in force for more than 20 years. The Consolidated text of Regulation (EU) 2017/745 and the Consolidated text of Regulation 2017/746 are available on the EUR-Lex website.
Tags
Organization
Country / Region
Italy
License
Creative Commons Attribution 3.0