The person responsible for regulatory compliance (PRRC) is not intended to take the place of a European Authorized Representative (EC Rep). The two positions, however, are mutually beneficial. As you may be aware, your EC Rep must be based in Europe and possess the credentials outlined in the MDR/IVDR. On the labelling, the EC Rep’s name and address must appear.
The EC Rep, on the other hand, does not have nearly as many obligations as the PRRC under Section 3, Chapter 1, Article 15 of the EU MDR.
Here’s a quick rundown of PRRC responsibilities:
- Ensure that all Technical Documentation and Declarations of Conformity are up to date
- Ensure that all postmarket surveillance and reporting
- Maintain conformity of the device inline with QMS protocol
Qualification Criteria for Person Responsible for Regulatory Compliance (PRRC)
The PRRC, according to the PRRC guideline paper, must have:
1. Medical device knowledge is required
2. A university degree, diploma, or other formal credentials is required, and
3. At least one year of experience in European regulatory affairs or quality systems management linked to medical devices is required.
OR…they must have four years of professional experience in European regulatory affairs or quality systems management linked to medical devices if they do not have a university degree, diploma, or other qualification.
Experience with European regulatory issues and QMS regulations is vital. It won’t have ten years of FDA experience but little or no European RA/QA experience.
No outsourcing! the permanent staff as your PRRC
If your firm does not satisfy the criteria of a micro/small business, you must choose a competent person to function as your Person Responsible for Regulatory Compliance. Fortunately, the EU MDR enables you to appoint “at least” one person inside your firm to be in charge of regulatory compliance. Still, they must live in Europe, according to paragraph 6 of the PRRC guideline.
There is no restriction on the number of PRRCs you can have. Larger companies may have many people in this position, each with specific responsibilities based on product lines or compliance requirements (e.g., technical documentation, postmarket surveillance, or new product development). All you have to do now is describe who these people are, explain how skilled and competent they are, and outline their separate responsibilities. Remember that each PRRC must be situated in the EU, and each legitimate manufacturer must have its PRRC under the parent business!
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