Who is a PRRC?
PRRC stands for Person Responsible for Regulatory Compliance. With the new EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), the EU regulators want to ensure that companies have a qualified regulatory expert- a PRRC at their disposal to ensure that the company complies with the regulatory requirements.
What are the requirements for PRRC?
The medical device and IVD manufacturers shall have within their organisation, a Person Responsible for Regulatory Compliance (PRRC) whereas the small and micro manufacturers may not have a PRRC within the organisation but must have one such person permanently and continuously at their disposal. For the Authorized Representatives (AR), they shall have one PRRC permanently and continuously at their disposal. The PRRC should have proper expertise and qualification in the field of medical devices or IVDs, whichever is applicable.
What should be the qualification of PRRC?
The Article 15 of MDR and IVDR clearly mentions the required qualifications and professional experience that a Person Responsible for Regulatory Compliance (PRRC) should possess which are:
- a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant science, and a minimum of one year of professional experience in regulatory affairs or in quality management systems concerning medical devices
- any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognised by an EU Member State as equivalent to the EU corresponding qualification.
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices and EU requirements in the field.
Who should appoint a PRRC?
- Manufacturers: The manufacturers shall have at least one PRRC within their organization with accurate expertise in the field of medical devices in the EU. This is valid when the organization has at least 50 employees in the company. The PRRC appointed by the large manufacturers should be the employee of the company.
- Distributors and Importers: The distributors and importers who modifies an existing device, changes the intended purpose of existing device or makes available a device on the European market is considered as a manufacturer and should appoint a PRRC.
- Other persons acting as manufacturer: Any legal or natural person who modifies an existing device, changes the intended purpose of existing device or makes available a device on the European market is considered as a manufacturer and should appoint a PRRC. This is because the person assumes the obligations that the manufacturer is responsible for.
- Assembler of Systems and procedure packs: The companies who assembles devices into a system or procedure pack using the devices which do not bear the CE marking, or the sterilization is not performed as per the protocols or the combination of devices is not compatible, then such system or packs are considered as medical device and hence such organization has to appoint a PRRC.
- Authorized Representatives: They should have permanently and continuously at their disposal a PRRC who has required expertise.
Where can the PRRC be located?
It is very important to have a close linkage between the manufacturer and the PRRC. Considering this fact, it is assumed that for a manufacturer based outside EU the PRRC will also be located outside EU and for a manufacturer based inside EU the PRRC will be located inside EU. Whereas in case of the micro and small manufacturers located inside the EU the PRRC should be permanently and continuously available at their disposal and hence the PRRC should be located inside EU. Considering that the authorized representative is located inside EU, it is assumed that the PRRC should be permanently at its disposal and hence should be located inside EU.
What are the roles and responsibilities of PRRC?
- Conformity of the devices should be checked and should be in accordance with the QMS
- The technical documentation and the declaration of conformity should always be up to date.
- The post marketing surveillance obligations should be complied
- The reporting obligations should be fulfilled by the PRRC.
Can a company have more than one PRRC?
Yes, more than one PRRC can be appointed by the companies and the responsibilities can be divided, as long as the qualification requirements are met and the division of responsibilities is documented in writing.
How many PRRC should an organization with more than one legal manufacturer have?
If a parent company has more than one legal manufacturer, then it is necessary to ensure that each legal manufacturer has a PRRC appointed.
Can one individual be the PRRC for a manufacturer and its authorised representative?
The PRRC for an authorized representative and for a manufacturer based outside EU cannot be same. In the regulations for authorized representative, it is clearly mentioned that PRRC will be an additional level of scrutiny. Therefore, if the same person acts as PRRC for both, the additional level of scrutiny would be compromised.
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