The Medical Devices Regulation (EU) 2017/745 has introduced some major innovations to the European regulatory legislative framework. Among the various areas disciplined by the Regulation, MDR has brought about some innovation in respect to the players of the regulatory field, namely on the figure of the Authorised Representative (AR) and it clearly outlined the role of the Person Responsible for Regulatory Compliance.
According to the MDR, the Authorized Representative plays a pivotal role in ensuring the compliance of the devices and in serving as extra-EU manufacturers’ contact person established in the Union.
The AR is jointly responsible for defective products and must terminate the contract with the manufacturer in case the manufacturer has not complied or in case it acts in a way that conflicts with the obligations laid down in Article 10. Consequently, the AR is liable for defective products when the manufacturer has not complied with its obligations.
Differently from what laid down by the Medical Devices Directive 93/42/EEC, the MDR clearly states that the AR is mandatory for non-EU manufacturers only; and solely on the basis of a received and accepted mandate to act on behalf of the manufacturer.
MDR furthermore clearly outlines the core of the role of the AR and its obligations and the minimum qualifications that this figure must hold. The minimum role of the AR encompasses a series of obligations, such as:
- To verify that the technical file and other essential documents have been drawn-up, and that the manufacturer has complied with his registration obligations;
- To provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device;
- To forward to the manufacturer any request by its competent authority for device sample;
- To cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices;
- To immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
As per the minimum qualifications, the Authorized representatives shall have permanently and continuously at their disposal at least one Person Responsible for Regulatory Compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following 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, OR
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
MDR has outlined the figure of the Person Responsible for Regulatory Compliance (PRRC) and cleared out its role in relation to the AR and to the manufacturer. Each Authorized Representative has to have its own PRRC, whose role is to ensure that the:
- “Minimum mandate” between the manufacturer and the AR fulfils all the requirements of the regulations and it is signed by both parties;
- AR correctly performs the tasks as defined in the regulations’ articles 11.,
- Responsibilities as laid down in article 15.3 and in the mandate are fulfilled by the AR.
Each Authorized Representative has to have at least one PRRC, that should be located in the EU. Manufacturers of medical devices must have a PRRC as well, provided that the PRRC’s roles for the AR and for the Manufacturer cannot overlap for the sake of keeping an additional level of scrutiny entrusted to the AR as envisaged by the Regulations.