Outsourcing Your PRRC: A Guide for Small Businesses Under EU MDR

For small and micro-enterprises navigating the European Union’s Medical Device Regulation (EU MDR), the requirement to appoint a Person Responsible for Regulatory Compliance (PRRC) presents a significant challenge. This role, defined in Article 15 of the regulation, demands extensive expertise in medical device regulations and quality management systems. While outsourcing this function is a practical solution, understanding the associated costs and service models is critical for effective budgeting and partnership. The total cost of an external PRRC service is not a single flat fee but is influenced by a combination of pricing models and specific company-related factors. Providers typically use retainers for core availability and bill for additional, intensive activities on an hourly basis. The device's risk class, the size of the product portfolio, and the maturity of the manufacturer's Quality Management System (QMS) are the primary drivers that determine the final cost. A clear service agreement that explicitly defines in-scope and out-of-scope activities is essential to prevent unexpected expenses and ensure regulatory obligations are fully met. ### Key Points * **Hybrid Pricing is Standard:** Most PRRC service providers use a hybrid model, combining a fixed monthly or annual retainer for basic responsibilities with an hourly rate for intensive, out-of-scope tasks like audit support or incident management. * **Risk Class is a Major Cost Driver:** The cost increases significantly with the risk classification of the devices. A portfolio of Class IIb or Class III devices will command a much higher fee than one consisting of Class I sterile or measuring devices due to the increased liability and complexity. * **Scope Definition is Crucial:** The service agreement must clearly delineate which tasks are covered by the retainer (e.g., high-level oversight, document verification) and which are billable (e.g., hands-on remediation, audit participation, vigilance reporting). * **Liability and Insurance Matter:** Companies must verify that the outsourced PRRC provider carries adequate professional liability insurance. The level of coverage should be appropriate for the potential risks associated with the medical devices. * **Internal Liaison is Necessary:** Outsourcing the PRRC role does not remove all internal responsibility. The manufacturer must have a knowledgeable internal contact who can effectively collaborate with the external PRRC, provide necessary documentation, and implement required actions. ## Understanding PRRC Service Pricing Models The cost of outsourcing the PRRC role is rarely a one-size-fits-all price. Service providers use several models to structure their fees, often combining them to align cost with the actual workload. Understanding these models is the first step for a small business to accurately budget for this essential function. ### Common Pricing Structures 1. **Annual or Monthly Retainer:** This is the most common foundation for a PRRC service agreement. The retainer secures the availability of a named, qualified PRRC and typically covers the core, ongoing oversight responsibilities mandated by Article 15. The fee is fixed and paid regularly (e.g., monthly or annually). 2. **Hourly Rate for Services:** For tasks that fall outside the retainer's scope, providers charge an hourly rate. This model is used for unpredictable, time-intensive activities where the workload is difficult to forecast. Rates will vary based on the provider's experience and location. 3. **Hybrid Model (Retainer + Hourly):** The vast majority of "PRRC as a Service" offerings are based on a hybrid model. The retainer covers the baseline duties and ensures the provider's name can be formally associated with the manufacturer's QMS. All additional work is then billed hourly, providing a balance of cost predictability and flexibility. 4. **Project-Based Fees:** Less common for ongoing PRRC services, this model might be used for a one-time, large-scale task, such as a complete overhaul and review of a Technical File prior to a Notified Body submission. ### Key Variables That Influence Cost The final price of a retainer and the provider's hourly rates are determined by several key factors related to the manufacturer's specific situation. * **Device Risk Classification:** This is arguably the single most significant cost driver. * **Class I (non-sterile/measuring):** Lowest cost, as the PRRC's involvement is less intensive. * **Class I (sterile/measuring), Class IIa, Class IIb:** Moderate to high cost. The complexity of the technical documentation, clinical evidence, and post-market surveillance requirements increases substantially. * **Class III and Implantable Devices:** Highest cost. The level of scrutiny, liability, and required expertise is maximal, commanding premium fees. * **Portfolio Size and Complexity:** The number of device families and the technical complexity of the products directly impact the workload. A company with ten distinct device families will require more oversight than a company with a single product. * **Maturity of the Quality Management System (QMS):** A manufacturer with a well-established, well-documented, and compliant QMS will require less hands-on support from the PRRC. Conversely, a company with a new or deficient QMS will likely incur higher costs as the PRRC service provider may need to bill for additional hours to help address foundational gaps. * **Company Size and Structure:** The size of the organization can influence coordination complexity. Larger teams may require more structured communication, which can translate to more time from the PRRC. ## Defining the Scope of Services: In-Scope vs. Out-of-Scope A common source of friction between manufacturers and service providers is a misunderstanding of what is included in a standard retainer fee. A robust service agreement will clearly define these boundaries. ### What is Typically Included in a Retainer? The retainer fee generally covers the PRRC's core oversight responsibilities as outlined in Article 15(3) of the EU MDR. These are often supervisory and verification activities, not hands-on content creation. * **Verification of QMS Conformity:** High-level review to ensure the QMS is established and implemented in accordance with the MDR. * **Verification of Technical Documentation:** Ensuring the technical documentation and EU declaration of conformity are properly drawn up and kept up-to-date. This is a check for completeness and process conformity, not a full re-authoring of the documentation. * **Oversight of Post-Market Surveillance (PMS):** Verifying that the company's PMS obligations are being met according to their established plan. * **Oversight of Vigilance Reporting:** Ensuring that serious incidents and field safety corrective actions are reported to the relevant competent authorities in a timely manner. * **Named Availability:** Serving as the officially designated PRRC for the organization in regulatory documentation. ### What is Typically Out-of-Scope (Billable Activity)? Out-of-scope activities are typically tasks that are time-intensive, unpredictable, or fall into the category of "doing" rather than "overseeing." * **Active Audit Participation:** Time spent preparing for, attending, and responding to findings from Notified Body or Competent Authority audits. This is almost always billed hourly. * **Vigilance Incident Management:** While oversight is included, the hands-on management of a serious incident—including investigation, root cause analysis, and drafting the vigilance report—is a significant undertaking and will be billed as extra work. * **Technical Documentation Creation or Remediation:** If the PRRC identifies major gaps in the technical documentation, the work required to fix those gaps is the manufacturer's responsibility. If the service provider is asked to perform this remediation, it will be a separate, billable project. * **Managing a Field Safety Corrective Action (FSCA):** Leading the strategy and execution of a product recall or other FSCA is a major, unpredictable event that falls well outside a standard retainer. ## Scrutinizing the Service Agreement: A Checklist for Small Businesses Before signing a contract, small businesses should carefully review the service agreement for more than just the price. The non-financial terms are critical for establishing a successful long-term partnership and avoiding hidden risks. **Key Contractual Elements to Review:** 1. **Clear Definition of Scope:** Does the agreement contain a detailed list of activities included in the retainer and a clear statement that all other activities will be billed at a specified hourly rate? 2. **Liability and Indemnity Insurance:** Does the provider hold professional liability insurance? Ask for proof of coverage and ensure the amount is sufficient for the risk level of your devices. 3. **Availability and Service Level Agreement (SLA):** How is availability defined? The contract should specify response times for both routine inquiries and urgent regulatory matters, such as a serious incident. 4. **Confidentiality:** A robust non-disclosure clause is essential to protect your intellectual property. 5. **Termination Clause:** Understand the conditions under which either party can terminate the agreement. What is the notice period? What are the provider’s obligations to ensure a smooth transition to a new PRRC? 6. **Succession Plan:** What happens if the individual assigned as your PRRC leaves the service provider? The agreement should outline the process for assigning a new, equally qualified individual. 7. **Audit Support Costs:** The agreement should explicitly state the costs for both remote and on-site support during audits, including travel and expenses. ### A Note on Global Regulatory Roles: PRRC vs. U.S. Agent It is important for companies operating in multiple markets to understand the differences between regional regulatory roles. The EU MDR PRRC is an operational role with deep responsibilities for the QMS and technical documentation. This differs significantly from the U.S. FDA's requirement for a U.S. Agent for foreign establishments. The U.S. Agent role, defined under regulations like **21 CFR** Part 807, is primarily a communications link between the FDA and the foreign manufacturer. While critical, it does not carry the same level of direct responsibility for compliance verification as the PRRC. Companies should consult **FDA guidance documents** for a full understanding of U.S. requirements. ## Finding and Comparing PRRC as a Service (EU MDR) Providers Choosing the right PRRC service provider is a critical decision. It is not just about finding the lowest price, but about finding a partner with the right expertise, availability, and cultural fit for your organization. When evaluating potential providers, manufacturers should look for a combination of deep EU MDR expertise, experience with similar device types and risk classes, and transparent business practices. It is essential to conduct thorough due diligence by interviewing multiple candidates, asking for references, and carefully comparing their service agreements. Using a specialized directory can streamline this process by connecting you with pre-vetted experts. > To find qualified vetted providers [click here](https://cruxi.ai/regulatory-directories/prrc_service) and request quotes for free. ## Key EU MDR References When discussing PRRC requirements, sponsors should always refer to the official regulatory texts and guidance documents. Key references include: * **Regulation (EU) 2017/745 (the EU MDR):** Article 15 explicitly defines the role, responsibilities, and qualifications of the Person Responsible for Regulatory Compliance. * **MDCG 2019-7:** This guidance document from the Medical Device Coordination Group provides detailed interpretation and clarification on the PRRC role as described in Article 15 of the MDR and IVDR. --- *This article is for general educational purposes only and is not legal, medical, or regulatory advice. For device-specific questions, sponsors should consult qualified experts and consider engaging FDA via the Q-Submission program.* --- *This answer was AI-assisted and reviewed for accuracy by Lo H. Khamis.*