Responsible for Regulatory Compliance

Manufacturers or their representatives must have on their staff a person responsible for regulatory compliance, as required by (EU) regulations 2017/745 and 2017/746.

Micro and small companies can subcontract this function, thus avoiding unbearable and unjustified costs.

We can be the “Person Responsible for Regulatory Compliance” (PRRC) for your company, ensuring that:

  1. a) 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. b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
  3. c) the post-market surveillance obligations are complied with in accordance with Article 10;
  4. d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
  5. e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.