Medical Device Regulation MDR (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation IVDR (EU) 2017/746 state that every medical device manufacturer whose products are on the EU market is required to have at its disposal a Person Responsible for the Regulatory Compliance (PRRC).
Having a PRRC is a must. If you do not have one, no European Notified Body will ever certify you. But even if the certification is not needed, meaning that your products are non-sterile class I medical devices that are not reusable surgical instruments and are not intended for measuring, you must have the PRRC.
In addition, it is the responsibility of the EU Authorized Representative (if you need one) to ensure that you have the PRRC. The name of the PRRC is communicated to the European Union authorities by means of the EUDAMED registration. If Competent Authorities need to contact a medical device manufacturer, they will foremost turn to PRRC.
The responsible person may be appointed from among the employees of the company. However, small medical device companies may also engage a third party to provide the PRRC functions.
To ensure compliance with MDR or IVDR the Person Responsible for Regulatory Compliance must control the following aspects:
PRRC activities should be properly documented. Upon request, evidence of this activity shall be provided to the Competent Authorities.
When deviations and inconsistencies are identified, PRRC develops and initiates measures aimed at ensuring / restoring compliance.
Not everyone could be your PRRC. The Person Responsible for Regulatory Compliance must have a suitable education (e.g. medicine, biotechnology, etc.) and a diploma recognized in Europe, as well as experience in the field of European regulatory affairs and/or quality management for medical devices.
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