The role of EU PRRC
The European regulations have evolved into being ever more complex. The New EU Medical Device Regulation (2017/745) (MDR) and In Vitro Diagnostic Regulation (2017/746) (IVDR) have added to the complexity.
In order to continue with compliance and regulatory checks, the European regulators have introduced a new role!
Medical device manufacturers must now appoint a Person Responsible for Regulatory Compliance (PRRC). Article 15 of the European MDR and IVDR mandate the appointment of the Person Responsible for Regulatory Compliance (PRRC). The June 2019 EU PRRC guidance document provides clarity on the requirements.
Difference between EU Authorised Representative and PRRC
The PRRC does not replace the European Authorised Representative (EC Rep). In fact, both of the roles are interdependent. The EC Rep/ EU AR must be located in Europe and meet requisite qualifications and labelling requirements but the PRRC doesn’t have such extensive requirements.
Section 3, Chapter 1, Article 15 of the EU MDR cites the following as
the responsibilities of PRRC:
- Check the 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
What are the qualifications required to be a Person Responsible for Regulatory Compliance (PRRC)?
According to the PRRC guidance document, the PRRC must have:
- Requisite expertise in the field of medical devices, and
- University degree, diploma, or some other formal qualifications, and
- At least one year of experience in European regulatory affairs or quality systems management related to medical devices,
OR…if no university degree, diploma, or other qualification, they must have four years of professional experience in European regulatory affairs or quality systems management related to medical devices. An essential point to note is that the experience should be in European regulatory affairs and QMS requirements. Having 10 years of FDA experience but little or no European RA/QA experience won’t cut it.
Interestingly, this role might improve the regulatory scene and ensure complete compliance with the new regulations but it does seem to increase restraints on manufacturers. Our experts will be happy to discuss any queries you may have and discuss potential solutions. Contact our Experts for a free consultation.
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