The Role of PRRC under MDR & IVDR: What You Need to Know
As a medical device manufacturer or Authorized Representative (AR) under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), you are required to have a person responsible for regulatory compliance (PRRC) in your company. This role is mandated in Article 15 of both the MDR and IVDR and is a critical part of ensuring that your devices meet the regulatory requirements and are safe for patients.
Responsibilities of a PRRC
The PRRC role is a crucial part of regulatory compliance and is responsible for five major tasks under the MDR and IVDR.
1. The PRRC is responsible for checking the conformity of devices in accordance with the quality management system (QMS) the company uses before the device is released. This is to ensure that the device meets the required standards and is safe for patients.
2. The PRRC ensures that technical documentation and the EU documentation of conformity are generated and up-to-date. This documentation includes technical files, declarations of conformity, and any other necessary documents required by the regulations.
3. The PRRC makes sure that the company complies with post-market surveillance obligations listed in Article 10(10) of MDR and Article 10(9) of IVDR. This includes monitoring the performance of the device in the market, identifying any issues, and taking appropriate actions to address them.
4. The PRRC is responsible for ensuring that the company fulfills its reporting obligations, found in Articles 87-91 of MDR and Articles 82-86 of IVDR. This includes reporting any adverse events, incidents, or field safety corrective actions to the relevant authorities.
5. The PRRC ensures that the statement from Section 4.1 of Chapter II of Annex XV of the MDR is issued if the company is building an investigational device. For the IVDR, this statement is located in Section 4.1 of Annex XIV.
If a company uses more than one PRRC, the distribution of responsibilities between them needs to be put down in writing.
Qualifications of a PRRC
The PRRC role is a significant responsibility and requires a person with specific qualifications. Article 15(1) of both MDR and IVDR call for the PRRC to have either:
- A diploma (or other formal qualification from a university or equivalent course of study) in law, medicine, pharmacy, engineering, or another relevant scientific subject, AND at least one year of professional regulatory or quality management experience in the medical device or in vitro diagnostic device fields.
- Four years of professional regulatory or quality management experience in the medical device field or in vitro diagnostic device fields.
Additionally, the professional experience in regulatory affairs or quality management “should be related to the EU requirements in the field.” This means that the PRRC should have experience working with the EU regulatory requirements for medical devices and in vitro diagnostic devices.
Outsourcing the PRRC role
While the PRRC is typically an employee of the device company, outsourcing this role is possible under certain conditions. According to the MDR and IVDR regulations, device companies with fewer than 50 full-time employees and less than €10 million in global sales (micro or small enterprises) are eligible to outsource the PRRC role to a third-party firm.
However, it is important to note that the regulations still stipulate that this person must be “permanently and continuously” at the company’s disposal. This means that the third-party firm must be available to the device company whenever needed, and the PRRC must be integrated into the company in such a way that allows them to perform their duties as if they were an employee.
The company is ultimately responsible for ensuring that the PRRC is adequately trained, has access to all necessary information, and is able to carry out their responsibilities effectively. Failure to comply with these requirements can result in penalties and other legal consequences.
Therefore, it’s crucial to choose a reliable and experienced third-party firm to outsource the PRRC role and ensure continued compliance with the MDR and IVDR regulations.
Need a PRRC?
For companies that fall in to the micro or small enterprises category, CENIT Consulting can represent your organization as the named PRRC in order to meet the requirements of the MDR/IVDR.