PRRC

PRRC
Person Responsible for Medical Devices

Person responsible for compliance

Person responsible for compliance

Micro and small businesses will not be required to have a PRRC within their organization, however they must have this resource available to them on an ongoing basis. 
In accordance with Commission Recommendation 2003/361 / EC, the definition of micro and small businesses is provided below : 
  • micro: Employees < 10, Annual Turnover and Annual Balance Sheet Total < EUR 2 million;
  • small: Employees < 50 and Annual Turnover and Annual Balance Sheet Total < EUR 10 million.
The PRRC shall ensure that:
  • the conformity of the device is adequately checked according to the manufacturer's quality management system, prior to release; 
  • the technical documentation and the EU declaration of conformity are drawn up and kept up to date. 
  • Post market surveillance requirements are met 
  • Reporting requirements are met 
  • In the case of devices under investigation, the declaration referred to in section 4.1 of Annex XV (MDR) and Annex XIV (IVDR) is issued. 
Multiple PRRCs may be appointed, which may further delegate control to other PRRCs until all activities are completed. 

Manufacturers and authorized representatives will be required to provide the name, address and contact details of the person(s) responsible for compliance at the time of registration in EUDAMED or when marking devices.
MDQ Services Ltd can provide this service.

MDQ Services Ltd can provide for you this service.
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MDQ's services as PRRC are set up:

 Custom made

The role of PRRC needs an annual fee for the responsabilities of the role. The fee is set up on the company dimension and product families. 
Every activity is then explained in an accurate price quotation.

Performance

Post market analysis and reporting. The importance of monitoring perfomance is recognised, we know where to find the information.

 Compliant

One of our qualified Engineer will take care of the conformity of your products. Devices conformity will adequately check in accordance with the quality management system, prior to release.

Small package

Designed specifically for micro entrprises: it contains the annual fee and the basic activities designed for small business

Medium package

Designed specifically for small companies: it contains the annual fee and the basic activities designed for medium business

Large package

Designed specifically for large companies: it contains the annual fee and the basic activities designed for big companies

Looking for a PRRC for Medical Devices?
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We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help. 
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