Q: Should an EU Authorised Representative have a Person Responsible for Regulatory Compliance?

The Authorised Representative , i.e. the person appointed to act on behalf of the manufacturer, and to whom the authorities and institutions of the Member States may turn with regard to obligations defined by legal requirements concerning medical devices, should also be in constant contact with the Person Responsible for Regulatory Compliance. It is also worth to add that the PRRC working for the manufacturer cannot be the same person as the person responsible for the Authorised Representative. There is a clear distinction these individuals to ensure an additional level of control and oversight over the manufacture of medical devices and post-market surveillance .

Question 1

Qualifications of the Person Responsible for Regulatory Compliance

Accepted Answer

The Person Responsible for Regulatory Compliance, in order to be able to perform regulatory and medical device quality duties in a reliable and appropriate manner, should have the appropriate qualifications, which are clearly defined in the MDR. These include a degree in a relevant scientific discipline and experience in regulatory and Quality Management Systems for medical devices obtained or compatible with EU requirements in this respect. Also micro and small enterprises should have permanent and continuous access to the services of such a person, however, the responsible person does not have to be employed within the organisation. This service can be outsourced. It is worth to mention that if a company would like to outsource the service of a PRRC, this person must be qualified to assess compliance with the latest EU medical device regulations. This is a key service provider for the company and should therefore be secured through a properly structured contract. When registering a medical device, manufacturers and authorised representatives will be required to provide the name, address and contact details of the person or persons responsible for regulatory compliance, as well as informing of any change in the details of such person.

Question 2

What are the responsibilities of the person responsible for regulatory compliance?

Accepted Answer

verifying the compliance of medical devices with the requirements of the MDR and the Quality Management System, including compliance with company procedures,

drawing up and updating the technical documentation,

participation in the obligatory post-market surveillance of the product,

product registration.

Question 3

Who should employ a Person Responsible for Regulatory Compliance?

Accepted Answer

Micro and small companies should have permanent and continuous access to the services of such a person. The service can be outsourced. Larger companies should have such a person within their organisation.

Question 4

Should an EU Authorised Representative have a Person Responsible for Regulatory Compliance?

Accepted Answer

The Authorised Representative, i.e. the person appointed to act on behalf of the manufacturer, and to whom the authorities and institutions of the Member States may turn with regard to obligations defined by legal requirements concerning medical devices, should also be in constant contact with the Person Responsible for Regulatory Compliance. It is also worth to add that the PRRC working for the manufacturer cannot be the same person as the person responsible for the Authorised Representative. There is a clear distinction these individuals to ensure an additional level of control and oversight over the manufacture of medical devices and post-market surveillance.