Within the EU regulations – MDR: (EU) 2017/75; and IVDR: (EU) 2017/746 - companies are obliged to have a qualified regulatory expert on staff or at their disposal to ensure the company is meeting EU requirements.
This (new) role of ‘Person Responsible for Regulatory Compliance’ [PRRC] is defined in the EU MDR and IVDR (Article 15).
The PRRC is different than an EU Authorized Representative
The PRRC does not replace the European Authorized Representative (EU AR). The EU AR must be located in the EU and meet requisite qualifications that are well defined in the MDR and IVDR. The EU AR’s name and address must appear on labeling. However, the EU AR does not have nearly as many responsibilities as those assigned to the PRRC in Section 3, Chapter 1, Article 15 of the EU MDR and EU IVDR.
An abbreviated list of PRRC responsibilities:
- Check conformity of devices with QMS procedures before they are released;
- Make sure all Technical Documentation and Declarations of Conformity are up to date;
- Ensure all post-market surveillance and reporting obligations are met.
Qualifications of the Person Responsible for Regulatory Compliance
The EU MDR and IVDR stipulate that the PRRC must have:
- Requisite expertise in the field of medical devices, +
- A university degree, diploma, or some other formal qualifications, +
- At least one year of experience in regulatory affairs or quality systems management related to medical devices, or
- If no university degree, diploma, or other qualification, must have four years of professional experience in regulatory affairs or quality systems management related to medical devices
Medical device companies don’t need a PRRC on staff if…
What happens if a company outsource all of regulatory compliance?
Article 15 offers some relief to “micro and small” enterprises exempt from having a PRRC on staff. Basically, you are exempt from having a PRRC on staff if, at the close of your most recent accounting period, you had:
- Fewer than 50 FTE global employees, and
- Under €10 million in sales/turnover (global revenue, not just EU)
You’ll notice that there is no exemption for manufacturers that are only marketing low-risk devices in Europe. All companies need a PRRC. European Commission Recommendation 2003/361/EC spells out the definition of “micro and small” companies as mentioned above.
Can the PRRC be outsourced? Can it be more than one person?
If your organization do meet the definition of a micro/small company, you can outsource this role as long as the person to whom you’re outsourcing the role is qualified and “permanently and continuously” at your disposal.
If your organization is located outside the EU, your Authorized Representative (EU AR) could fulfill the PRRC role for you. It must be justified and evidenced that your PRRC is permanently and continuously at your disposal if your facility is located outside the EU. It should also be noted that a PRRC is also required for the Authorized Representatives according to Article 15(6). If you have appointed an importer or distributor as your Authorized Representative, you need to justify and to evidence the PRRC qualifications and responsibilities!
If a micro/small company does not have someone with the regulatory expertise on staff. This means you may need to contract an registered and recognized regulatory service provider as us to act as your PRRC. Remember, your outsourced PRRC needs to be qualified to handle European medical device regulatory compliance. After all, your PRRC will be considered a critical supplier and you should have appropriate agreements in place. As part of your supplier qualification process, this also includes contractors or consultants supporting your compliance efforts. If you outsource your PRRC, remember the stipulations above that this individual will be responsible for compliance with procedures, Technical Documentation, and postmarket surveillance obligations. This outsourced PRRC must be permanently available and integrated into the organization in a manner that allows you to fulfill the requirements of the EU MDR/IVDR.