Appointment of the Person Responsible for Regulatory Compliance (PRRC)
The designation of a Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement for all manufacturers and importers of medical devices and in vitro diagnostic devices under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
The PRRC is the individual appointed to ensure that all medical devices placed on the European Union market comply with the applicable legal and regulatory requirements, including conformity assessment, post-market surveillance, and product safety.
We offer a comprehensive PRRC service, assuming this critical role on behalf of your company. We ensure that all MDR/IVDR obligations are met efficiently and in full compliance with European legislation, allowing you to focus on your core business operations while we manage your regulatory responsibilities.
Our services include
Acting as the PRRC
Acting as the PRRC, taking full responsibility for ensuring that your company complies with all legal and regulatory requirements under MDR/IVDR
Overseeing the conformity assessment process
Overseeing the conformity assessment process for your medical devices from development through to market placement
Managing post-market surveillance
Managing post-market surveillance, including continuous monitoring of device safety and risk management
Drafting and maintaining the required documentation
Drafting and maintaining the required documentation, such as vigilance plans, risk management files, and compliance reports
Providing ongoing training and regulatory updates
Providing ongoing training and regulatory updates to ensure your company remains compliant with the latest requirements
This service is essential for:
External PRRC
Micro and small companies can hire an external PRRC to ensure compliance with the European Medical Device Regulation (MDR). This option is advantageous because it eliminates the need to maintain an internal PRRC, thus reducing operational costs
With our support, you can
PRRC obligation
Fulfil the legal obligation to appoint a PRRC
MDR/IVDR requirements
Ensure full compliance with all MDR/IVDR requirements throughout the entire device lifecycle
Minimise the risk of non-compliance
Minimise the risk of non-compliance and safeguard both your company’s reputation and user safety
