Your Guide to Evaluating and Budgeting for an EU MDR PRRC Post-2026

Your Guide to Evaluating and Budgeting for an EU MDR PRRC Post-2026 Under the EU Medical Device Regulation (MDR), the role of the Person Responsible for Regulatory Compliance (PRRC) is a mandatory and critical function for all manufacturers. For many organizations—particularly non-EU based companies, startups, and small-to-medium enterprises (SMEs)—outsourcing this role to a qualified "PRRC as a Service" provider is the most practical and efficient solution. As organizations plan their regulatory budgets for 2026 and beyond, understanding how to evaluate and budget for this service is essential. The cost of an outsourced PRRC is not a fixed, one-size-fits-all fee. Instead, it is a strategic investment that varies based on a range of factors, including the manufacturer's size, the complexity of its device portfolio, and the specific scope of services required. A thoughtful evaluation process involves looking beyond the price tag to assess the provider's expertise, the depth of their proposed engagement, and how they will integrate with the manufacturer's quality management system (QMS) to ensure sustained compliance. ## Key Points * **Mandatory and Strategic Role:** The PRRC is a non-negotiable requirement under Article 15 of the EU MDR. This person is legally responsible for overseeing critical compliance activities, making the selection a strategic decision. * **Cost is Highly Variable:** Budgeting for a PRRC service depends directly on factors like device risk class (e.g., Class I vs. Class III), portfolio size and complexity, and the manufacturer's internal regulatory maturity. * **Scope of Service Defines the Investment:** A basic "named PRRC" service to meet the legal requirement is fundamentally different—and less expensive—than a comprehensive partnership that includes hands-on review of technical documentation, post-market surveillance plans, and QMS integration. * **Qualifications Are Non-Negotiable:** Providers must meet the specific qualification criteria outlined in Article 15. Manufacturers must verify a provider's credentials and, critically, their experience with similar device types. * **Integration is Crucial for Success:** An effective outsourced PRRC must be properly integrated into the manufacturer's QMS. The processes for document review, change control, and vigilance reporting must be clearly defined in a Service Level Agreement (SLA). * **View it as a Long-Term Partnership:** The PRRC function is an ongoing responsibility. The most successful engagements are structured as long-term partnerships where the provider acts as a trusted advisor, not just a name on a registration form. ## Understanding the Core Responsibilities of the PRRC To budget effectively, manufacturers must first understand the scope of work the PRRC is legally required to perform. Article 15 of the EU MDR outlines five key areas of responsibility. The complexity of these tasks for your specific device portfolio will be the primary driver of the service provider's workload and, therefore, the cost. 1. **Conformity of Devices:** Ensuring that the conformity of the devices is appropriately checked in accordance with the QMS under which the devices are manufactured before a device is released. 2. **Technical Documentation and Declaration of Conformity:** Confirming that the Technical Documentation and the EU Declaration of Conformity are drawn up and kept up-to-date. 3. **Post-Market Surveillance (PMS) Obligations:** Ensuring that the PMS obligations are complied with in accordance with the manufacturer's PMS system. 4. **Reporting Obligations:** Ensuring that vigilance reporting obligations (e.g., for serious incidents and field safety corrective actions) are fulfilled. 5. **Investigational Devices:** For investigational devices, ensuring that a statement is issued confirming the device conforms to the General Safety and Performance Requirements (GSPRs), apart from the aspects covered by the clinical investigation. ## Key Factors Influencing PRRC Service Costs A robust budget for PRRC services accounts for the specific needs of the organization. The following factors are the most significant drivers of cost. #### ### 1. Device Risk Class and Portfolio Complexity The risk associated with a device is the single most important factor. * **Low-Risk Devices (e.g., Class I, Class IIa):** A portfolio of Class I reusable instruments or simple software applications involves a lower liability and a more straightforward technical file. The PRRC's oversight may be less intensive, leading to a lower cost. * **High-Risk Devices (e.g., Class IIb, Class III):** An active implantable device, a novel AI-powered diagnostic tool, or a device using animal-derived tissues requires a much higher level of scrutiny. The PRRC must have deep expertise to review complex clinical data, risk management files, and post-market clinical follow-up (PMCF) plans. This specialized knowledge and higher liability command a significantly higher fee. * **Portfolio Size:** A manufacturer with dozens of device families will require more PRRC time for batch record reviews, PMS report updates, and change management than a company with a single product. #### ### 2. Scope of Services and Engagement Model Providers typically offer a range of engagement models. It is critical to select a model that aligns with your internal resources and compliance needs. * **Named PRRC (Basic Compliance):** This is the most basic model, where the provider agrees to be named as the PRRC for legal purposes. Active involvement is minimal and usually limited to being available in case of an audit. This is the least expensive option but offers little practical support. * **Retainer Model (Advisory Support):** A common model where the manufacturer pays a fixed monthly or quarterly fee for a set number of consulting hours. This is suitable for companies that have an internal team to handle day-to-day tasks but need an expert for review, sign-off, and strategic advice. * **Project-Based Model (Targeted Support):** This model is used for specific, time-bound tasks, such as remediating a Technical Documentation file for a Notified Body audit or developing a new PSUR template. * **Fully Integrated Model (Comprehensive Partnership):** The provider becomes a deeply integrated part of the manufacturer's regulatory and quality functions. They may regularly participate in management reviews, sign off on all major changes, and actively manage the PMS and vigilance systems. This is the most comprehensive and expensive model, typically reserved for high-risk devices or companies with limited internal expertise. #### ### 3. Manufacturer Size and Regulatory Maturity The existing capabilities of the manufacturer play a large role. * **Startups and Micro-Enterprises:** A new company may lack a mature QMS or an experienced regulatory team. The PRRC service provider may need to provide more foundational support, effectively acting as a part-time Head of RA/QA. * **Established SMEs:** A company with a mature QMS and an internal regulatory team may only need the PRRC for final oversight and to fulfill the legal requirement. The workload is lower, reducing the cost. ## Scenario-Based Budgeting Examples To illustrate how these factors come together, consider two common scenarios. #### ### Scenario 1: A Non-EU Startup with a Single Class IIa SaMD Product * **Profile:** A small, non-EU based software company has developed a Class IIa Software as a Medical Device (SaMD) for patient monitoring. They have a strong technical team but limited in-house regulatory expertise. * **Needs:** They primarily need to fulfill the legal requirement of having an EU-based PRRC. They also require expert guidance on creating MDR-compliant Technical Documentation and a lean PMS plan. * **Likely Service Model:** A **Retainer Model**. The startup would likely budget for a provider to act as the named PRRC and include a block of 5-10 advisory hours per month. This allows them to get expert review on key documents and strategic advice without the cost of a fully integrated service. * **Budgeting Focus:** The budget should prioritize a provider with proven SaMD and cybersecurity experience. The cost will be moderate, reflecting the lower device risk but higher need for initial guidance. #### ### Scenario 2: A Medium-Sized Manufacturer with Class III Cardiovascular Implants * **Profile:** An established manufacturer with a portfolio of Class III drug-eluting stents and related delivery systems. They have an internal regulatory affairs team that manages submissions. * **Needs:** This company requires a PRRC with profound expertise in high-risk cardiovascular devices. The PRRC's role is not just advisory but involves critical sign-off on clinical evaluation reports (CERs), PMS activities, and vigilance reports for devices with high liability. * **Likely Service Model:** A **Fully Integrated Model** or a substantial retainer. The PRRC would need to be deeply involved in the QMS, reviewing and approving critical documents and changes. Their availability for unannounced Notified Body audits is crucial. * **Budgeting Focus:** The budget must reflect a top-tier expert. The cost will be significant, as the provider is taking on substantial responsibility for a high-risk portfolio. The focus is on expertise and reliability over price. ## Strategic Considerations for Selecting a PRRC Provider * **Define the Service Level Agreement (SLA):** Your contract with the provider should be highly detailed. It should specify response times for questions, turnaround times for document reviews, availability for audits (both scheduled and unannounced), and the precise scope of responsibilities. * **Plan for QMS Integration:** How will the outsourced PRRC access your document control system? What is the defined workflow for them to review and approve a change order or a new SOP? These practical details must be worked out before signing a contract. * **Verify Qualifications and Experience:** Do not rely solely on a CV. Ask for references and specific examples of their experience with devices similar to yours. For a novel device, their experience with the underlying technology is more important than experience with an identical product. * **Assess Liability and Insurance:** Understand the provider's professional liability insurance. The PRRC role carries significant legal responsibility, and you must ensure the provider is adequately covered. ## Finding and Comparing PRRC as a Service (EU MDR) Providers When evaluating potential PRRC service providers, it is essential to conduct a structured comparison. Instead of focusing only on the quoted price, create a checklist to compare proposals on an apples-to-apples basis. Your evaluation should cover: * **Verifiable Qualifications:** Do they clearly meet the requirements of Article 15 of the EU MDR? * **Relevant Device Experience:** Have they worked with devices of a similar risk class and technology? * **Proposed Service Model:** Does the scope of work described in the proposal match your actual needs? * **Integration Plan:** Do they have a clear process for integrating with your QMS? * **References:** Can they provide references from satisfied clients of a similar size and profile? By carefully defining your needs and systematically comparing providers, you can find a partner who provides both compliance and strategic value. 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 with potential providers, it is helpful to be familiar with the core regulatory sources. * **EU Medical Device Regulation (EU) 2017/745:** Article 15, "Person responsible for regulatory compliance," is the primary source defining the role, responsibilities, and qualification requirements. * **MDCG 2019-7:** This guidance document from the Medical Device Coordination Group provides detailed interpretation and practical advice on implementing the requirements of Article 15 for both the MDR and IVDR. * **Guidance on Post-Market Surveillance (PMS) and Technical Documentation:** As the PRRC is responsible for overseeing these areas, familiarity with relevant MDCG guidance on PMS, PMCF, PSURs, and Summary of Safety and Clinical Performance (SSCP) is also beneficial. --- 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.*