The new Regulations have introduced the role of the Person Responsible for Regulatory Compliance (PRRC). Manufacturers that want to rely on CE marking, manufacturers of custom made devices and authorized representatives must appoint a PRRC.
For smaller companies and authorized representatives this can be outsourced. Boumans Regulatory Consulting can execute the role of the PRRC or act as a back-up PRRC. For larger organizations and/or companies based outside the EU there is another arrangement possible.
Boumans Regulatory Consulting will use their role as PRRC to provide training to staff and be a guide for management. But this will also imply having a PRRC with whom you will have in-depth discussions you don’t want to have with your notified body or competent authority. This service can also be used in a growth model, where a future PRRC or team of PRRC’s, is trained and coached. Note that only a handful of these long lasting commitments can be taken up. As a PRRC I will help you to stay compliant and to look compliant.
With eleven years of working as a senior inspector for the Dutch competent authority, you may expect sufficient experience for the role of PRRC in any organization.
Your outsourced PRRC
Boumans Regulatory Consulting can offer three types of PRRC service:
- Standard outsourced PRRC; this service consists of review of procedures, work instructions and forms, relevant training for staff and management and a review of the process of manufacturing, from product design to PMS/PMCF. At least once a year the PRRC will report to upper management on compliance. This role can also be used to train and coach a future PRRC, of team of PRRC’s, in their role as formal PRRC.
- Proxy PRRC; this service consists of the same elements as the standard outsourced PRRC, except that this is done in a role where the official PRRC is assisted. The role of proxi PRRC is typically recommended for companies that too large to outsource a PRRC, while medical devices make up only a small part of their port folio. This is typically seen in the pharmaceutical and cosmetic industry. This may also be a service supplied to a company outside the EU. This service can also be used to train and coach future internal PRRC’s.
- Deputy PRRC; this service consists of a backup for the official PRRC, where the backup PRRC only jumps in if there is an urgent situation while the formal PRRC is not available. This role is also important to bridge a gap in the availability of a PRRC that left the company, until a new PRRC is appointed. In small companies, where a manager has taken the role of the PRRC, there is a risk of missing points when they are checking their own work. A deputy PRRC may provide an extra control to ensure the official PRRC stays on track. This service can also be used to train and coach the company’s PRRC.
- PRRC consultation service; this service consists of a budget for the PRRC that they can use to have a discussion with an outside expert. This can be about anything, ranging from a basic review of the annual planning cycle to high end discussions about a problem running out of control. This is quite comparable with a standard ad hoc service, but this budget is controlled by the PRRC and exclusively theirs.