PRRC services for Medical Device Manufacturers

Ensure hassle-free PRRC compliance in Europe

For North American and European micro-small medical and IVD device manufacturers, GrowthImports provides outsourced PRRC services aimed to increase your quality standards and comply with Article 15 of the MDR/IVDR.

Guaranteeing compliance. Cost Effective. Tailored to your needs.

Outsource your PRRC to our Experts

With decades of expertise in regulatory and international market development services exclusively for worldwide medical device companies, you will gain a trusted PRRC partner in your organization.

PRRC Services (Article 15 MDR/IVDR)

Article 15 of the MDR/IVDR regulations mandates medical manufacturers exporting medical goods to the EU, to comply with Article 15 and designate an employee who is responsible for regulatory compliance.

If your company is located in North America or in Europe and have fewer than 50 full-time employees and less than € 10 mln in global sales, you do do not need to hire your own employee and can outsource your PRRC. 

We will integrate the PRRC within your company and will be permanently and continuously available to meet the regulation requirements and provide adequate support.

PRRC Roles and responsibilities

Given the responsibilities of the PRRC role, GrowthImports’ PRRC specialists will meet the specific qualifications and include the following responsibilities:

  • The conformity device meets regulatory standards.
  • Technical documentation is established and maintained.
  • Post-market surveillance activities are compliant with regulations.
  • Incidents are recorded and reported and that field safety corrective actions are implemented.
  • A statement has been issued in case of investigational devices. (MDR) or IVD devices.
  • intended for use in interventional clinical effectiveness studies (IVDR).
Cost effective and Flexible PRRC solutions

Our PRRC services are specifically designed for smaller sized medical and IVD device manufacturers. It offers a cost-effective and flexible solution while meeting the medical device regulations in the European Union.

Receive our PRRC proposal and comply with Article 15 MDR/IVDR

Our PRRC experts will schedule a free assesment to explore your possibilities