--- title: "PRRC Definition & Meaning | MedTech Terms" description: "Named individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer. Plain-English Regulatory definition for MedTech team" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/prrc#term", "name": "Person Responsible for Regulatory Compliance", "alternateName": "PRRC", "description": "PRRCs must possess defined qualifications and experience and are personally responsible for conformity checks, technical documentation maintenance, post-market surveillance, vigilance, and clinical investigation reporting.", "url": "https://medtechterms.com/terms/prrc", "termCode": "prrc", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/prrc#article", "headline": "PRRC, Person Responsible for Regulatory Compliance", "description": "Named individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer.", "url": "https://medtechterms.com/terms/prrc", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/prrc" }, "about": { "@id": "https://medtechterms.com/terms/prrc#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Person Responsible for Regulatory Compliance, PRRC, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "MDCG 2019-7 PRRC", "url": "https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en", "publisher": { "@type": "Organization", "name": "MDCG" } }, { "@type": "CreativeWork", "name": "RAPS Regulatory Focus", "url": "https://www.raps.org/news-and-articles/news-articles", "publisher": { "@type": "Organization", "name": "RAPS" } }, { "@type": "CreativeWork", "name": "FDA - Medical Devices", "url": "https://www.fda.gov/medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ec-rep#term", "name": "Authorized Representative (EU)", "alternateName": "EC REP", "url": "https://medtechterms.com/terms/ec-rep" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr#term", "name": "EU Medical Device Regulation", "alternateName": "MDR", "url": "https://medtechterms.com/terms/mdr" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "Person Responsible for Regulatory Compliance", "item": "https://medtechterms.com/terms/prrc" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/prrc#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary role of a PRRC under EU MDR?", "acceptedAnswer": { "@type": "Answer", "text": "The primary role of a PRRC is to ensure that medical devices consistently meet the requirements of the EU MDR, covering areas such as conformity assessment, technical documentation, and post-market obligations." } }, { "@type": "Question", "name": "Can a PRRC be a shared role?", "acceptedAnswer": { "@type": "Answer", "text": "No, Article 15(1) of the EU MDR states that manufacturers shall have at least one PRRC. For small and micro enterprises, the PRRC may be external, but the ultimate responsibility rests with the manufacturer." } }, { "@type": "Question", "name": "What qualifications must a PRRC possess?", "acceptedAnswer": { "@type": "Answer", "text": "A PRRC must possess either a diploma, certificate, or other evidence of formal qualification in a relevant scientific or technical discipline, plus at least one year of professional experience in regulatory affairs or quality management systems relating to medical devices, or four years of professional experience in regulatory affairs or quality management systems relating to medical devices without a formal qualification." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Person Responsible for Regulatory Compliance [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)PRRC # Person Responsible for Regulatory Compliance Named individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition PRRCs must possess defined qualifications and experience and are personally responsible for conformity checks, technical documentation maintenance, [post-market surveillance](/terms/post-market-surveillance), vigilance, and clinical investigation reporting. What the regulation says The [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting)) 2017/745, specifically Article 15, mandates the appointment of a Person Responsible for Regulatory Compliance (PRRC) for manufacturers and authorized representatives. This individual ensures compliance with the regulation, overseeing aspects like conformity assessment procedures, technical documentation, and [post-market surveillance](/terms/post-market-surveillance). Similarly, the [EU In Vitro Diagnostic Regulation](/terms/ivdr) (IVDR) 2017/746 also includes provisions for a PRRC, mirroring the MDR requirements. ## What this means in practice Small manufacturers can engage an external PRRC; importers and authorized representatives also have PRRC obligations under specific conditions. ## Examples - A medical device manufacturer appoints an internal employee with a master’s degree in biomedical engineering and two years of experience in quality assurance as their PRRC, documenting their qualifications and responsibilities in the quality management system. - A small start-up company developing an innovative diagnostic software engages an external consulting firm to provide PRRC services, ensuring that the consultant meets the experience and qualification criteria outlined in EU MDR Article 15. - During an audit, an notified body reviews the PRRC’s job description, curriculum vitae, and evidence of continuous professional development to verify compliance with regulatory requirements. Common pitfalls - • A common pitfall is misunderstanding that the PRRC’s personal liability extends to criminal charges in certain jurisdictions for non-compliance. - • Companies often fail to adequately define the PRRC’s direct access to management and resources, hindering their effectiveness. - • Organizations may mistakenly believe that appointing an external PRRC absolves them of their own regulatory compliance responsibilities. - • Inadequate documentation of the PRRC’s qualifications and experience can lead to non-conformities during audits. - • Manufacturers sometimes neglect to update the PRRC’s responsibilities and training as regulations evolve or product portfolios change, leading to compliance gaps. ## Frequently asked questions What is the primary role of a PRRC under EU MDR? The primary role of a PRRC is to ensure that medical devices consistently meet the requirements of the EU [MDR](/terms/mdr-reporting), covering areas such as conformity assessment, technical documentation, and post-market obligations. Can a PRRC be a shared role? What qualifications must a PRRC possess? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Authorized Representative (EU)(EC REP) Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes. ](/terms/ec-rep)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 MDCG· 1 RAPS· 1 FDA· 1 1. [1 MDCG 2019-7 PRRC Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) 2. [2 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym PRRC Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=prrc) Learn in 60 seconds Card Lesson Quiz Named individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer. - · Small manufacturers can engage an external PRRC; importers and authorized representatives also have PRRC obligations under specific conditions. Remember this Watch out: A common pitfall is misunderstanding that the PRRC’s personal liability extends to criminal charges in certain jurisdictions for non-compliance. Related terms - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) - [EU Medical Device Regulation(MDR) ](/terms/mdr) You may also need Auto-suggested from Regulatory and shared keywords. - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [UK Responsible Person(UKRP) ](/terms/ukrp) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [Common Specifications(CS) ](/terms/common-specifications) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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