According to European Regulations on Medical Devices and in vitro diagnostic medical devices, manufacturers shall have available at least one person responsible for regulatory compliance who possess demonstrated expertise in the field of medical devices.
The Person Responsible for Regulatory Compliance (PRRC) shall be at least responsible for ensuring that:
a)Conformity of devices are appropriated with the relevant Quality Management System (QMS)
b)The technical documentation and EU DoC are up-to date
c)Post market surveillance obligations are properly performed
d)Reporting obligation on serious incidents and field safety corrective actions are met
Manufacturers would be wise to hire this position with qualified professionals to:
1.Be compliant with the EU regulatory requirements
2.Ensure the safety and compliance of the marketed devices
3.Avoid any financial penalties or reputational harm
If you need a PRRC, Contact us to know what Osmunda can do for you!