PRRC
for Medical Devices

Person responsible for compliance with regulations

Person Responsible
for compliance with regulations

Micro and small businesses will not be required to have a PRRC within their organization, but 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 enterprises is provided below:
  • micro enterprises: fewer than 10 employees and annual turnover/total annual balance sheet
  • small enterprises: fewer than 50 employees and annual turnover/total annual balance sheet

The PRRC for medical devices must ensure that:

  • the conformity of the device is adequately checked in accordance with 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 obligations are complied with;
  • reporting obligations are complied with;
  • in the case of devices under investigation, the declaration referred to in Section 4.1 of Annex XV (MDR) and 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 shall provide the name, address, and contact details of the person or persons responsible for regulatory compliance when registering in EUDAMED or when marking devices.
Altrion can provide this service.
Contact us

Book a PRRC

Altrion’s services as a PRRC for medical devices are

Custom-made

The annual amount is determined based on the size of the company and the number of product families marketed. Each activity is then defined in a detailed quotation.

Performance

Post-market analysis and reporting. The importance of performance monitoring is widely recognized.

We know where to find the information.

Compliance

We handle product evaluation and documentation in the initial phase; device compliance will be adequately verified according to MDR requirements and those of the competent authorities.

Are you looking for a prrc
for medical devices?

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