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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
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Person Responsible for Regulatory Compliance (PRRC) for medical device and IVD companies


According to the European Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation, it is a mandatory requirement for every medical device manufacturer with products on the EU market to appoint a Person Responsible for Regulatory Compliance (PRRC).



Are you in search of a PRRC in the EU? We have the expertise you need.

Whether you are a medical device manufacturer or an EU Authorised Representative seeking PRRC services, we are here to support you.

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PRRC ensurs compliance by overseeing:

  • Technical Documentation
  • Quality System
  • System for Collecting and Updating Clinical Data
  • Post-Registration Surveillance System

PRRC basic facts

Does the PRRC have to be an employee of the company?

The designation of the responsible person can be done from within the company's employees. Nevertheless, smaller medical device companies have the option to enlist a third-party service to fulfill the PRRC functions.

Qualifications of PRRC

PRRC must possess appropriate qualifications, such as education in fields like medicine or biotechnology and a diploma recognised in Europe + experience in European regulatory affairs for medical devices.

What are the functions of PRRC

The Person Responsible for Regulatory Compliance (PRRC) plays a crucial role in ensuring compliance with MDR or IVDR by overseeing the following aspects:

It is essential that all PRRC activities are well-documented, and evidence of these activities must be provided to Competent Authorities upon request. In case of any deviations or inconsistencies, the PRRC takes prompt action to develop and initiate measures aimed at ensuring or restoring compliance.

Does the PRRC have to be an employee of the company?

The designation of the responsible person can be done from within the company's employees. Nevertheless, smaller medical device companies have the option to enlist a third-party service to fulfill the PRRC functions.

Qualifications of PRRC

The role of PRRC is not open to everyone. The Person Responsible for Regulatory Compliance must possess appropriate qualifications, such as education in fields like medicine, biotechnology, etc., and a diploma recognised in Europe. Additionally, experience in European regulatory affairs and/or quality management for medical devices is essential for fulfilling this role.

By choosing us for your PRRC needs, you get a reliable partner who knows European regulations well.

Send us an email:
info@mdrc-services.com

Or use the contact form below