Which regulation governs medical devices in Europe?

The Medical Device Regulation (MDR) 2017/745 is the current framework that governs medical devices within Europe. This regulation, which came into full effect in May 2021, replaced the previous directives, including the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The MDR is comprehensive, providing strict guidelines concerning the safety, efficacy, and overall performance of medical devices.

This regulation emphasizes a risk-based classification system, increased post-market surveillance, and the necessity of clinical evaluations to ensure that devices not only meet safety standards but are also suitable for their intended purposes. Furthermore, the MDR mandates a more thorough involvement of notified bodies in the assessment of devices before they can be marketed, ensuring enhanced oversight throughout the lifecycle of medical devices.

In contrast, the options referring to the Medical Device Safety Directive, the European Healthcare Regulation, and the Medical Product Compliance Standards do not accurately reflect the current regulatory landscape for medical devices in Europe. These alternatives either refer to outdated frameworks or are entirely fictitious, thus highlighting the significance of the MDR in contemporary European medical device regulation.