European Union Laws for Regulation of Medicines and Medical Devices
The European Union (EU) has several laws and regulations in place for the regulation of medicines. The main legislation governing the authorization, supervision, and safety of medicinal products in the EU is the "Regulation on medicinal products for human use" and "Regulation on veterinary medicinal products".
The European Medicines Agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicinal products in the EU. Companies seeking to market a medicine in the EU must go through a centralized authorization procedure with the EMA. After a positive evaluation, the medicine will be granted a marketing authorization valid in all EU member states.
For the regulation of medical devices, the main legislation governing the authorization, supervision, and safety in the EU is the "Regulation on Medical Devices" (MDR) and "Regulation on In-Vitro Diagnostic Medical Devices" (IVDR).
The main objective of these regulations is to ensure that all medical devices authorized for sale in the EU meet high standards of quality, safety, and performance. They lay down the rules for the authorization, supervision, and post-market surveillance of medical devices and establish the European Medicines Agency (EMA) and European Medical Devices Coordination Group (MDCG) as the central point for the scientific evaluation of medical devices in the EU.
The MDR and IVDR have replaced the previous EU Medical Device Directive and In-Vitro Diagnostic Directive and came into effect on May 26, 2021. The new regulations set out stricter rules for the safety and performance of medical devices and increase the responsibilities of manufacturers and authorized representatives.
Manufacturers must demonstrate the safety and performance of their devices through clinical evaluation and performance testing. They must also appoint an authorized representative in the EU and keep detailed technical documentation on their devices.
