A new requirement within the MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostic Regulation) both require companies to appoint a PRRC (Person Responsible for Regulatory Compliance).
All manufacturers, whether inside or outside the EU, must have a PRRC. Companies acting as an EU Authorized Representative must also have a PRRC.
Many manufacturers, classed as micro or small companies, do not have such a person available within the company. International Associates Limited can offer a service to cover this role.
So just what is this new role:-
It is a requirement that the PRRC has a close link with the manufacturing processes.
- The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device, is released;
- The technical documentation and the EU declaration of conformity are drawn up.
and kept up-to-date;
- The post-market surveillance obligations are complied with in accordance with Article 10(10) [Article 10(9) of the IVDR];
- The reporting obligations referred to in Articles 87 to 91 [Article 82 and 86 of the IVDR] are fulfilled;
- In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV [Section 4.1 of Annex XIV of the IVDR] is issued.
What Qualifications / Experience is required?
The PRRC must have a diploma in
- Or other Scientific Discipline
And one year in Regulatory Affairs or Quality Management System on Medical Devices.
Alternatively, you can also become a PRRC if you have four years of experience in Regulatory Affairs or Quality Management System for Medical Devices.
You can have more than one person who is responsible.
What if you do not have this type of person within your company?
If you cannot look to appoint someone within the company or take on a qualified person to fulfill the role, then you can nominate International Associates Limited to take on the tasks required.
However, the regulations and guidance allow that an external person can be the PRRC if the company is micro or small (i.e., less than 50 staff or less than €10m TO). but they must be “Permanently” and “Continuously” at the disposal of the company.
Can my Responsible Person be my PRRC?
The simple answer is No! The person responsible for regulatory compliance, for an authorized representative, and for an ‘outside EU’ manufacturer cannot be the same person. There is a clear desire within the Regulations for the authorized representative to be adding an additional level of scrutiny and ensure that the supervision and control of the manufacture of devices, and the relevant post-market surveillance and vigilance activities are adequately affected. If the same person conducted the two roles, the additional level of scrutiny would be undermined.
Hence, if you already have an EU Authorized Representative who is within the EU, then you need to appoint a separate PRRC which could be International Associates Limited.
What procedures/documents must be in place?
You must officially appoint the person or external person in writing; it’s also a good idea to also show them on the organization chart, job description, contract, etc.
Are Distributors required to have a PRRC?
Distributors do have to have an appointed PRRC if they carry out activities such as changing a product.
As part of the EUDMED registration process, you will see there is also a requirement to register the details of the person who is acting as the PRRC. (Annex VI, Part A 1.4) including the name and address.
You can find out more information in the EU guide. Here. https://ec.europa.eu/docsroom/documents/36166