PRRC

Person Responsible for Regulatory Compliance

Maintaining compliance to the European regulations can be confusing, difficult and time consuming, especially since the release of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). With the new regulations, it is incumbent upon companies to always have a qualified regulatory expert at their disposal to ensure the company is meeting EU requirements.

According to Article 15(3) the person responsible for regulatory compliance shall at least be responsible for ensuring that:

  1. the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
  2. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
  3. the post-market surveillance obligations are complied with in accordance with Article 10(10);
  4. the reporting obligations referred to in Articles 87 to 91 are fulfilled;
  5. in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

For our clients that fall in to the micro or small enterprises category, our consultants have the qualifications to represent your organization as the named PRRC in order to meet the requirements of the MDR/IVDR.

 

CENIT Consulting can provide this service for companies that need to contract in a PRRC. For larger organizations looking to hire, we have the network and knowledge to assist in finding the right PRRC, see our recruitment services.

Contact us to find out more about our PRRC service