In January 2023, new EU rules on medical devices (set out in EU Regulation 2017/45, known as the Medical Devices Regulation) entered into force in Romania, following the issuing of Emergency Ordinances 46/2021 and 137/2022 and their related application norms.
The Medical Devices Regulation has been significantly updated, marking the first major change in more than 20 years to legislation in the field at EU level and represents a paradigm shift, which offers a golden opportunity to drive innovation and growth in the EU’s Life Science sector while ensuring patient safety remains at the heart of the regulatory approach. The Regulation brings a series of crucial improvements to the conformity assessment for medical devices:
- It will lead to an improvement in the quality, safety and reliability of medical devices placed on the European market;
- It will strengthen transparency of information related to medical devices for consumers and practitioners;
- It will enhance vigilance and market surveillance of devices in use.
The implementation of the EU Regulation in Romania has involved a number of steps. These comprised:
- The setting up of the Romanian National Agency for Medicines and Medical Devices (“ANMDMR”) as the relevant authority in the field of medical devices. It is also the market surveillance authority;
- The introduction of special provisions to ensure the transparency and traceability of medical devices focusing on improving health and safety, through the use of the Unique Identification System of a medical device;
- Clarifications on the language in which the information provided as part of a software system for a medical device must be drafted;
- The establishment of conditions under which the export of medical devices from Romania can be carried out;
- The setting of penalties applicable in the event of non-compliance with the provisions of the European Regulation on medical devices.
This new legislation is an important step forward in improving the quality of health care available to the Romanian population through the application of common European standards on medical devices.
