Regulatory Compliance Person Responsible (FERP / PRRC) Regulation (EU) 2017/745 requires in Article 15 (at least) one person who is responsible for compliance with the regulatory provisions. This person or persons are responsible for ensuring that
- the conformity of the products is appropriately checked in accordance with the quality management system under which the products are manufactured before a product is released,
- the technical documentation and the EU declaration of conformity are created and kept up to date,
- the post-market surveillance obligations under Article 10 (10) are met;
- the reporting obligations under Articles 87 to 91 are met,
- in the case of test products, the declaration in accordance with Annex XV, Chapter II, Section 4.1 is made.
For small and very small companies, however, there is the option of outsourcing this responsibility. This is where MEDAGENT comes in. – We would be happy to take over this service for you if required. Take advantage of our many years of professional experience in regulatory issues or quality management systems in connection with medical devices.