Cooley’s Productwise Bitesize brings you a short overview of the EU Medical Devices Regulation. What is it called? The Medical Devices Regulation (MDR Regulation (EU) 2017/745) governs the placing on the market in the European Economic Area (EEA) of medical devices and its accessories as well as clinical investigations taking […]
CE marking refers to the obligation on manufacturers to affix the letters “CE” to certain products traded in the European Economic Area (EEA). It serves as a declaration that the product is in conformity with applicable rules and meets certain health, safety and environmental requirements.
The EU adopted its new “circular economy” package on 30 March, 2022. The legislative package will have a big impact on many businesses and other product stakeholders.
Cooley’s Productwise Bitesize brings you a short introduction to the amended transitional provisions of the new In Vitro Diagnostic Medical Devices Regulation
Cooley’s Productwise Bitesize brings you an update on the upcoming regulation of groups of products without an intended medical purpose listed in Anne XVI to the MDR.