PRRC (EU MDR)
Why PRRC?
The European MDR (2017/745) and IVDR (2017/746) require that manufacturers, authorised representatives and other economic operators, if the obligations of the manufacturer apply to them, shall have a person that will be responsible for regulatory compliance (PRRC).
If your establishment is classified as a micro or a small enterprise, Meliora Compliance offers to serve as your external PRRC.
PRRC responsibilities:
- Conformity of devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- Technical documentation and EU declaration of conformity are drawn up and kept up-to-date;
- Post-market surveillance obligations are complied;
- Reporting obligations are fulfilled;
- In case of investigational devices, a signed statement that the device in question conforms to the general safety and performance requirements and that every precaution has been taken to protect the health and safety of a clinical study subject.
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