How to structure a PRRC contract for effective compliance
If you’re involved in the world of medical devices, you know that having a Person Responsible for Regulatory Compliance (PRRC) is essential for meeting EU regulations. The Medical Device Regulation (MDR) and In Vitro Diganostic Regulation (IVDR) both have specific requirements for this role laid out in Article 15 of both regulations, and a contract with your PRRC is important for staying compliant. But while it’s essential to meet these regulatory requirements, the contract with the PRRC can also be customized to fit your company’s unique needs. Here’s how to balance compliance with flexibility.
Following Article 15 MDR or IVDR
The requirements for a PRRC are nearly identical in both the MDR and IVDR, outlined in Article 15 of each regulation. For simplicity, we'll refer to these requirements collectively as Article 15, covering the responsibilities and qualifications necessary for compliance in both medical device and in vitro diagnostic sectors.
Article 15 requires that each medical device manufacturer has a PRRC on board. This person must have the necessary expertise in the medical device field.
When drafting a contract for a PRRC, it’s important to clearly outline their qualifications. These qualifications should, at a minimum, meet the baseline requirements specified in Article 15.
That said, the qualifications for a PRRC can indeed go beyond the minimum requirements outlined in Article 15. When drafting the contract, it’s wise to specify qualifications that best suit your company's specific needs and regulatory strategy.
For example, consider whether you need them to perform just the essential PRRC functions or if you could benefit from a broader range of compliance consulting services. Many PRRCs bring extensive experience in regulatory affairs and quality management, which can provide valuable insights beyond basic compliance duties.
The PRRC’s key responsibilities
The MDR and IVDR spell out specific responsibilities for the PRRC, which should be clearly detailed in the contract:
- Ensuring that devices align with quality management system standards before being released.
- Ensuring that technical documentation and the EU declaration of conformity are up to date.
- Making sure that ongoing monitoring and follow-up are handled according to MDR requirements.
- Verifying that the vigilance reporting meets requirements as outlined in MDR or IVDR.
- When necessary, providing documentation for devices in the investigation stage.
Additionally, you can outline any extra responsibilities for the PRRC in your contract, based on your mutual agreement. This flexibility allows you to tailor the PRRC role to fit your company’s specific needs, whether that means expanding their duties beyond the regulatory minimums or incorporating additional compliance-related tasks. Which takes us to the next section of this article.
Adding flexibility with customized terms
While meeting Article 15 is non-negotiable, there’s room to tailor the PRRC contract to suit your company’s specific needs. Here are some ways to personalize it:
- Availability - define the specific times or situations when the PRRC must be available.
- Reporting channels - outline the reporting structure, including who the PRRC reports to within the organization.
- Audit involvement - include responsibilities for internal audits or compliance checks.
- Extra focus areas - add any specific areas where you’d like the PRRC to concentrate, like product development or clinical trials.
These additional terms let you adapt the PRRC role to your company’s workflow and structure, making it easier to align with your operational needs. Just make sure they complement the core duties required by the regulations and don’t create any conflicts.
The PRRC can also play a role in various other critical areas, including post-market surveillance, clinical (performance) evaluation, post-market clinical (performance) follow-up, risk management, and essentially any documentation or compliance-related activities where additional support is beneficial.
Why a solid PRRC contract matters
A well-designed PRRC contract isn’t just about meeting MDR or IVDR requirements. It provides a framework that helps both you and your PRRC understand their role clearly, balancing compliance with the day-to-day realities of your business. By combining the essentials from Article 15 with flexible terms, you can ensure that your PRRC is fully equipped to keep your company compliant, without adding unnecessary complexity. This approach ultimately supports your business and your products in the highly regulated EU medical device market.
