--- title: The Person Responsible for Regulatory Compliance (PRRC) Under MDR Article 15 description: MDR Article 15 requires every manufacturer to designate a Person Responsible for Regulatory Compliance (PRRC) with specific qualifications — here is what startups need to know. authors: Tibor Zechmeister, Felix Lenhard category: MDR Fundamentals & Regulatory Strategy primary_keyword: canonical_url: https://zechmeister-solutions.com/en/blog/prrc-mdr-article-15 source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # The Person Responsible for Regulatory Compliance (PRRC) Under MDR Article 15 *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* Article 15 of the MDR requires every manufacturer and every authorized representative to have available within their organization at least one person responsible for regulatory compliance who possesses specific qualifications. This is the Person Responsible for Regulatory Compliance — the PRRC. It is one of the most concrete staffing requirements in the regulation, and it catches many startups by surprise. Here is what Article 15 requires, who qualifies, and how a startup with limited resources can meet this obligation. ## What Does Article 15 Require? Article 15(1) states that manufacturers must have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices . The PRRC must possess one of the following qualifications : **Option A:** A diploma, certificate, or other evidence of formal qualification awarded on completion of a university degree or of a course of study recognized as equivalent by the member state concerned, in law, medicine, pharmacy, engineering, or another relevant scientific discipline, AND at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. **Option B:** Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. The qualification requirements are cumulative for Option A (degree plus experience) and standalone for Option B (experience alone). ## What Are the PRRC's Responsibilities? Article 15(3) defines the minimum responsibilities of the PRRC : - Ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released - Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date - Ensuring that the post-market surveillance obligations are complied with - Ensuring that the reporting obligations for vigilance are fulfilled - In the case of investigational devices, ensuring that the statement referred to in Section 4.1 of Annex XV is issued The PRRC is not responsible for doing all of this work personally. They are responsible for ensuring it happens. The PRRC oversees the regulatory compliance system — they do not have to be the sole person executing every regulatory task. ## Does the PRRC Need to Be a Full-Time Employee? Article 15(2) addresses this directly for micro and small enterprises: micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC are not required to have the person responsible for regulatory compliance within their organisation but must have such a person permanently and continuously at their disposal . This is critical for startups. A micro enterprise is defined as an enterprise with fewer than 10 employees and an annual turnover or balance sheet total not exceeding EUR 2 million. A small enterprise has fewer than 50 employees and an annual turnover or balance sheet total not exceeding EUR 10 million . If your startup qualifies as a micro or small enterprise, you can use an external PRRC — someone who is not your employee but is "permanently and continuously at your disposal." This means: - They must be available to fulfill the PRRC responsibilities on an ongoing basis - They must have a contractual arrangement with your company - "Permanently and continuously at your disposal" implies regular availability, not occasional consulting — they must be reachable and responsive when needed, not just available for quarterly reviews ## How Do Startups Typically Fulfill the PRRC Requirement? ### Option 1: Internal PRRC If you have a team member with the requisite qualifications — a regulatory affairs professional, a quality manager with device experience, or a co-founder with the relevant background — they can serve as the PRRC. Advantages: - Full integration into your organization - Deep understanding of your product and processes - Available immediately when needed - No ongoing external fees Requirements: - They must meet the qualification requirements (degree + 1 year experience, or 4 years experience) - Their PRRC role must be formally documented - They must have sufficient time to fulfill PRRC responsibilities alongside their other duties ### Option 2: External PRRC (for micro/small enterprises) If you do not have a qualified internal candidate, you can engage an external PRRC. This is common for early-stage startups with small teams. Advantages: - Access to experienced regulatory professionals without a full-time hire - Lower cost than a full-time regulatory affairs hire - Immediate availability if you find the right person Requirements: - Must meet the Article 15 qualification requirements - Must be "permanently and continuously at your disposal" - Must have a formal contractual arrangement - Must understand your specific devices and processes well enough to fulfill the PRRC responsibilities Risks: - An external PRRC who is not deeply familiar with your operations may not catch compliance gaps that an internal person would see - "Permanently and continuously at your disposal" can be challenging to maintain with an external provider who serves multiple clients - The arrangement must be genuine — a PRRC in name only who never actually reviews your compliance status is a regulatory risk ### Option 3: Shared PRRC (Within a Group) If your startup is part of a corporate group, a single PRRC can serve multiple entities within the group, provided they have sufficient capacity and knowledge of each entity's devices and processes. ## What Do Auditors Check Regarding the PRRC? Notified Body auditors will verify: 1. **That a PRRC has been designated.** They will ask who your PRRC is and review the documentation of their appointment. 2. **That the PRRC meets the qualification requirements.** They will review the PRRC's CV, diplomas, and evidence of professional experience. 3. **That the PRRC actually fulfills their responsibilities.** They will ask the PRRC about their activities, review records of their oversight, and check whether the PRRC can demonstrate active involvement in compliance activities. 4. **That the PRRC has sufficient authority.** The PRRC must have the organizational standing to influence compliance decisions. A PRRC without the authority to stop a non-compliant device from being released is a PRRC in name only. The most common audit findings related to Article 15: - No PRRC designated (surprisingly common in startups) - PRRC does not meet qualification requirements - PRRC has no evidence of active oversight activities - External PRRC for a company that does not qualify as micro/small ## The Broader Significance of Article 15 Article 15 is more than a staffing checkbox. It reflects a fundamental principle of the MDR: the manufacturer must have competent people overseeing regulatory compliance. The regulation does not trust processes alone — it requires a named, qualified individual who takes responsibility. For a startup founder, this means regulatory compliance cannot be purely outsourced to consultants or purely delegated to junior staff. There must be someone with genuine expertise who is accountable for the compliance of your devices. Tibor's perspective on this is direct: "The PRRC requirement exists because the old system had companies where nobody actually understood the regulations their devices were supposed to comply with. Having a qualified person whose explicit job is to ensure compliance is not bureaucracy — it is basic responsibility." If you are building a startup in the medical device space, identifying your PRRC should be one of your first organizational decisions. If you have the qualifications yourself, you can be the PRRC. If you need to hire or contract someone, do it early — before you need them, not after. Next: [Do You Need a Full-Time PRRC? Options for Startups with Limited Resources](/blog/024-prrc-options-startups). --- *This post is part of the [MDR Fundamentals & Regulatory Strategy](https://zechmeister-solutions.com/en/blog/category/mdr-fundamentals) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*