Person Responsible for Regulatory Compliance (PRRC) for medical device and IVD companies

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).

Clinical evaluation

Are you looking for a PRRC in the EU?

Contact us:

+49 176 67510274

info@mdrc-consulting.com

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.

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

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.

Clinical evaluation

We will be happy to act as your PRRC in the EU. Depending on your country we can provide PRRC services outside the European Union as well.

Contact us to discuss your PRRC needs:

What are the functions of PRRC

To ensure compliance with MDR or IVDR the Person Responsible for Regulatory Compliance must control the following aspects:

  • technical documentation;
  • quality system;
  • system for collecting and updating clinical data;
  • post-registration surveillance system;

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.

Qualifications of PRRC

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.

Russia and EAEU authorized representative

If you need a PRRC, contact us:

+49 176 67510274

info@mdrc-consulting.com

Or use the contact form:

Person Responsible for Regulatory Compliance (PRRC) for medical device and IVD companies

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.

Clinical evaluation

Are you looking for a PRRC in the EU?

+49 176 67510274

info@mdrc-consulting.com

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

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.

Clinical evaluation

We will be happy to act as your PRRC in the EU. Depending on your country we can provide PRRC services outside the European Union as well.

+49 176 67510274

info@mdrc-consulting.com

What are the functions of PRRC

To ensure compliance with MDR or IVDR the Person Responsible for Regulatory Compliance must control the following aspects:

  • technical documentation;
  • quality system;
  • system for collecting and updating clinical data;
  • post-registration surveillance system;

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.

Qualifications of PRRC

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.

Russia and EAEU authorized representative

If you need a PRRC contact us:

+49 176 67510274

info@mdrc-consulting.com

Or use the contact form below

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