Person Responsible for Regulatory Compliance
The EU Medical Device Regulations 745/2017 (MDR) and 746/2017 (IVDR) will soon progressively replace the current directives, which have functioned in the EU legislation unchanged since the 1990s. Thus, the European Commission and other legal organisations across the Member States need to make sure medical companies have a qualified regulatory expert within their organisation to ensure the company’s compliance with the EU requirements.
To be able to accurately and properly perform the regulatory and quality functions with respect to medical devices, a Person Responsible for Regulatory Compliance (“PRRC”) must have the requisite qualifications as expressly set out in the MDR. These include a diploma in a relevant scientific discipline and professional experience in regulatory affairs or in quality management systems relating to medical devices earned in line or compatible with the related EU requirements.
Micro and small enterprises must have such a person permanently and continuously at their disposal but are not required to have a PRRC employed within their organisation. This service may be subcontracted to a third party.
Importantly, where a company wishes to subcontract the responsibilities of a Person Responsible for Regulatory Compliance, the third-party PRRC must have the qualifications to assess compliance with the latest EU medical device regulations. As such this is a key service provider of a company and, thus, the company must seek and obtain protection in the form of a properly structured contract.
The key responsibilities of a PRRC
- Check conformity of medical devices with the MDR and Quality Management System requirements, including compliance with the company’s procedures;
- Make sure all technical documentation is drawn up and up to date;
- Contribute to the mandatory post-market surveillance; and
- Provide product registration.
An Authorised Representative, or a person appointed to act on behalf of the Manufacturer and as a point of contact for authorities and institutions of the Member States in matters of the regulatory obligations for medical devices must also remain permanently and continuously in contact with a person responsible for regulatory compliance. It is worth adding that a person responsible for regulatory compliance who works for a Manufacturer may not be the same person as the one for an Authorised Representative. There is a clear demarcation between those persons to provide an added level of control and oversight over the manufacturing process of medical devices and post-market surveillance.
Manufacturers and Authorised Representatives will be required to provide the name, address and contact details of their Person(s) Responsible for Regulatory Compliance upon registration of a medical device and notify any change to the PRRC details.
MDR Regulator experts have the requisite qualifications and experience to act in the role of a Person Responsible for Regulatory Compliance at your company. For more information do get in touch with us.