Person responsible for Regulatory Compliance
Identification of at least one person responsible for regulatory compliance by manufactures and Authorised representatives is a requirement contained in the Regulations on medical devices and on in-vitro diagnostic medical devices, where the necessary qualifications are also defined.
What are the tasks of the person responsible for regulatory compliance?
The person responsible for regulatory compliance shall at least be responsible for ensuring that:
- 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;
- The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- The post-market surveillance obligations are complied;
- The reporting obligations are fulfilled;
- In the case of investigational devices, the statement of device safety and performance is issued.