Medicine
MedTech – New more stringent European MDR regulations and changes in MedTech
PUBLISHED IN News in Review: APRIL 2024
The European Parliament’s Regulation (EU) 2017/745 on medical devices (MDR)[1] is a new set of regulations that governs the production and distribution of medical devices within the European Union (EU). Medical device companies that want to sell their products in Europe must comply with the regulation, which replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The MDR aims to enhance the safety and effectiveness of medical devices while ensuring a consistent and high level of health protection for patients.
The MDR has a broader scope than the previous directives that it replaces. It includes a wider range of products, including certain aesthetic devices and products without a medical intended purpose. There are also increased requirements for clinical data and evidence, especially for high-risk devices. Manufacturers are expected to provide more robust clinical data demonstrating the safety and performance of their products.
In March 2023 the European Parliament extended the MDR transition periods for certain medical devices and in vitro diagnostic medical devices.
[1] https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
