7 april 2017

Regulations for medical devices and in vitro diagnostics adopted by European Parliament

On April 5, 2017 the European Parliament adopted a regulation for medical devices and a regulation for in vitro diagnostics. The new legislation will become effective in 2020 and 2022 respectively. These regulations will cause changes in the system of registration, research and post-marketing surveillance in the field of medical devices and in vitro diagnostics.

After implementation of the regulations, the effectiveness of medical devices must be better substantiated, which should lead to a better warrant of the safety and the encouragement of innovation. In addition, medical devices must meet more stringent requirements, including a larger amount of clinical evidence, to be eligible for marketing authorization.

The regulations will affect the way clinical trials with medical devices are registered and reviewed. The CCMO is expected to play a key coordinating role in that process. The Ministry of Health, Welfare and Sport, the Health Care Inspectorate, the RIVM and the CCMO are working on an implementation plan for the Netherlands.

See also the press release of the European Parliament.