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Person Responsible for Regulatory Compliance

Med-di-dia can act as your PRRC.

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What is Person Responsible for Regulatory Compliance [PRRC]?

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. 

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.

Under the Medical Device Regulation and In-Vitro Diagnostic Regulation, the Person Responsible for Regulatory Compliance will include the following responsibilities:

  • 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;
  • To ensure reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting;
  • The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices.

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Outsourcing - Person Responsible for Regulatory Compliance [PRRC]

According to MDR, micro and small enterprises can outsource the PRRC role to have an appropriately qualified person permanently and continuously at their disposal. Companies can take advantage of this provision and reduce the cost of hiring dedicated resources within the organisation. The outsourced PRRC must then be listed as a critical supplier on the manufacturers quality system, and an agreement must be in place between both parties.

Med-Di-Dia can support all companies with a Qualified and Dedicated expert who is Permanently and Continuously at your company's disposal.

Benefits of using Med-Di-Dia as your PRRC?

  • Use of Med-Di-Dia’s name and address for CE Mark labelling
  • Support for creating and updating technical documentation as per the MDR/IVDR
  • Registration of your device(s) with the Irish HPRA and EUDAMED when available
  • Provide support with Competent Authority questions related to the client’s device(s)
  • Presentation of the client’s technical documentation to Competent Authorities upon request
  • Contact the manufacturer to inform them of any reported complaints related to their devices
  • Access to a monthly regulatory intelligence newsletter outlining updates in the EU regulatory landscape
  • Access to ad-hoc regulatory support when required

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LATEST INSIGHTS

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Risk Management Analysis (ISO 14971:2019)

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A ‘Label’ is the identity of the product.

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It allows the identification of specific devices on the market and facilitates their traceability.

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