Person Responsible for Regulatory Compliance (PRRC) as a service
Ensure your compliance in an easy way
The EU MDR (2017/745) states that regardless of the device class, company size or location, when placing devices on EU market, manufacturer shall have available within their organization a Person Responsible for Regulatory Compliance who possesses the requisite expertise as defined in the regulation.
Person Responsible for Regulatory Compliance (PRRC) service
Fineltec's Medical Device Business Solutions (MDBS) offers EU MDR (2017/745) compliant PRRC service for medical device manufacturers.
MDBS will guide you through the process of naming PRRC. Once the service is up and running, MDBS will carry out the PRRC duties for you as required in EU MDR (2017/745) - allowing you to focus on your core.
PRRC role
EU MDR (2017/745) requires that manufacturers shall have available within their organization a person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. This person shall be responsible for ensuring that,
Key tasks
- Conformity of the device is adequately checked
- Technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
- Post market surveillance requirements are met
- Reporting obligations are met
- In case of investigational devices, the required statement according to Annex XV is issued
Conditions for different size organizations
EU MDR (2017/745) distinguishes micro and small enterprises from all other enterprises in regards of the PRRC requirements.
Micro and small enterprises
- Micro: Employees < 10, Turnover and Balance Sheet < 2 m€
- Small: Employees < 50, Turnover and Balance Sheet < 10m€
- PRRC is not required to be within organization, but
- PRRC shall be permanently and continuously at disposal
All other size enterprises
- PRRC is required to be part of your organization
- PRRC have to be added to your payroll
PRRC for micro and small enterprises
- Micro: Employees < 10, Turnover / Balance Sheet < 2million€ Small: Employees < 50, Turnover / Balance Sheet < 10million€
- Person Responsible for Regulatory Compliance
- Utilization of PRRC in EUDAMED registrations
- Competent Authority and Notified Body liaison
- Permanently and continuously at disposal
- 4 hours of PRRC work free of charge
PRRC for enterprises
- Companies not in accordance with definitions of 2003/361/EC. € 499 service fee + € 400 through payroll
- Person Responsible for Regulatory Compliance
- Utilization of PRRC in EUDAMED registrations
- Competent Authority and Notified Body liaison
- Part of your organization and payroll
- 4 hours of PRRC work free of charge
Get started
Our mission is to provide high quality services with a personal touch. We cooperate closely with our customers, helping them to grow together with a reliable partner. We understand our customers’ needs and assist them to be one step ahead on the fast-moving market.
- Established in 1993
- Nearly 100 employees
- Production facility of 4000 m2
- 17 million Euro turnover
- EU location
Our clients include
