Essentials of European Medical Device Regulatory Affairs

Person responsible for regulatory compliance

Key features • Manufacturers shall have available within their organization at least one person responsible for regulatory compliance • Micro and small enterprises are not required to have the person responsible for regulatory compliance within their organization but shall have such a person permanently and continuously at their disposal • The person shall suffer no disadvantage within the manufacturer's organization in relation to the proper fulfilment of his duties, regardless of whether or not he is an employee of the organization Qualifications • A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices • Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices

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Person responsible for regulatory compliance

Tasks •

Ensure the conformity of the devices is appropriately checked in accordance with the quality management system under which these devices are manufactured before a product is released • Ensure the technical documentation and the declaration of conformity are drawn up and kept up-to-date • Ensure compliance with post-market surveillance obligations • Ensure reporting obligations are fulfilled • In the case of investigational devices, to ensure that the statement referred to in point 4.1 of Chapter II of Annex XV is issued (MDR) • In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued

The Organisationfor Professionals inRegulatory Affairs