Person Responsible for Regulatory Compliance PRRC

Who is the Person Responsible for Regulatory Compliance (PRRC) for regulatory compliance?

The European Commission’s new MDR and IVDR regulations, which will soon replace the current directives, introduce a new position within the structures of medical companies: the Person Responsible for Regulatory Compliance (PRRC).

Who should employ the Person Responsible for Regulatory Compliance (PRRC)?

Micro and small enterprises should have permanent and continuous access to the services of such a person. The service may be outsourced. Larger companies should have such a person within the organisation.

What qualifications should the Person Responsible for Regulatory Compliance (PRRC) have?

This person should meet the qualifications specified unambiguously in the MDR and IVDR Regulations, i.e. qualifications to assess compliance with the latest EU regulations on medical devices.

How can we help?

Our Specialists are qualified and experienced to act Person Responsible for Regulatory Compliance in medical companies.

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