REGULATION 745/2017 ON MEDICAL DEVICES
Regulation 745/2017 came into force in 2021. This new regulation amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and repeals Council Directives 90/385/EEC and 93/42/EEC.
The medical devices sector is constantly evolving, with new advances in this field. The aim is to establish a regulatory framework that guarantees the supply of effective and safe medical devices.
This regulation provides a legal framework for medical devices that ensures a high level of quality, safety and health protection.
Requirements of Regulation 745/2017
Some of the new features introduced by this regulation are:
- The creation of a database (EUDAMED) to ensure transparency and to enable authorities, industry, healthcare professionals and the general public to access information on medical devices available on the European market.
- Improved traceability of medical devices through the implementation of a unique device identifier (UDI).
- Strengthening of the process for the designation and supervision of notified bodies.
- Stricter requirements regarding the pre-clinical and clinical data that medical devices must have before obtaining the CE mark.
- The creation of expert panels to provide the necessary technical support in the evaluation of innovative products.
- New obligations for economic operators involved with medical devices. With our medical device consultancy.
- Possibility of regulating the reprocessing of single-use devices at national level.
- Strengthening of market surveillance and control requirements.
- Greater coordination between the competent authorities for medical devices.
- Inclusion of certain non-medical devices listed in Annex XVI of the Regulation.