On 26 May 2021, EU Regulation 2017/745 on medical devices entered into force. This new Regulation addresses the needs for innovation, security and traceability.
This regulation amends the legislation (Directive 93/42/EEC among others) to take account of increasing innovation in the sector and to ensure the availability of products guaranteeing patient safety on European territory.
This new legislation aims to reinforce pre-market product control and intensify post-market surveillance. The traceability of devices is not left out either, as the Regulation provides for the introduction of a unique identification system for devices which will facilitate the recall of defective products and combat counterfeiting.
EU Regulation 2017/746 on in vitro diagnostic medical devices will enter into force on 26 May 2022.