Medical Safety Regulation
This Regulation aims to achieve a high level of protection of health for patients and users while ensuring the smooth functioning of the internal market as regards medicinal products, medical devices and in vitro diagnostic medical devices. At the same time, this Regulation establishes a framework to support Member State cooperation and the measures needed for clinical assessment of health technologies. Both objectives are being pursued simultaneously. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation sets out the procedures and the rules for carrying out joint work and establishing a framework at Union level.
This Regulation establishes:
- A support framework and procedures for cooperation of Member States on health technologies at Union level;
- A mechanism which lays down that any information, data, analyses and other evidence required for the joint clinical assessment of health technologies is to be submitted by the health technology developer only once at Union level;
- Common rules and methodologies for the join clinical assessment of health technologies
However, this Regulation does not affect Member States’ competence to draw conclusions on the relative effectiveness of health technologies or to take decisions on the use of a health technology in their specific national health context. It does not interfere with the exclusive national competence of Member States, including those for national pricing and reimbursement decisions, or affect any other competences which concern Member States’ management and delivery of health services or medical care or the allocation of resources assigned to them.