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Person Responsible for Regulatory Compliance (PRRC) Services
Ensuring regulatory compliance for medical devices and in-vitro diagnostic products is essential for market access, patient safety, and legal adherence. Simplimedica provides Person Responsible for Regulatory Compliance (PRRC) services, helping manufacturers navigate the complexities of EU MDR (Regulation (EU) 2017/745) and EU IVDR (Regulation (EU) 2017/746).
Our PRRC services offer manufacturers, particularly small and medium-sized enterprises (SMEs), access to highly qualified regulatory professionals who act as their designated PRRC. This ensures continuous compliance, proper oversight of technical documentation, and alignment with all regulatory requirements.
With Simplimedica’s PRRC Services, you gain peace of mind knowing that your regulatory obligations are fully met without the need to maintain permanent internal staff.
Why You Need PRRC Services
Simplimedica provides Person Responsible for Regulatory Compliance (PRRC) services fully aligned with the requirements of the EU MDR (Regulation (EU) 2017/745) and EU IVDR (Regulation (EU) 2017/746). Under these regulations, every manufacturer placing a medical device or in-vitro diagnostic device on the EU market must formally appoint at least one PRRC to oversee and ensure continuous regulatory compliance.
For small and medium-sized enterprises (SMEs) that may not have the internal resources, expertise, or capacity to employ a full-time regulatory specialist, Simplimedica offers a professional outsourced PRRC solution. This service provides manufacturers with access to highly experienced regulatory professionals who act as their designated PRRC, guaranteeing complete alignment with EU MDR/IVDR requirements.
Simplimedica PRRC Services — What We Offer
We help you meet compliance requirements and gain approvals across global markets with expert regulatory guidance.
Qualified EU PRRC designation
Simplimedica provides named individuals who meet EU MDR/IVDR qualification criteria, formally appointed as your external PRRC. Our consultants possess the necessary academic background and professional experience to manage regulatory oversight efficiently.
Continuous oversight
We monitor your technical documentation, post-market surveillance activities, and conformity assessments to ensure ongoing compliance. Simplimedica’s Person Responsible for Regulatory Compliance (PRRC) Services guarantee that all regulatory responsibilities are proactively managed.
Review and sign-off
Our PRRC professionals oversee product release, declarations of conformity, and technical file updates in accordance with MDR/IVDR requirements. This ensures that every product entering the market meets strict regulatory standards.
Change control and vigilance
We review all changes affecting product conformity, coordinate vigilance processes, and manage adverse event escalation. With Simplimedica’s PRRC Services, your compliance systems remain up-to-date and responsive to regulatory changes.
Quality system interface
Our PRRC integrates with your Quality Management System (QMS) to verify continued compliance with MDR/IVDR and ISO 13485 standards. This alignment ensures that operational processes remain consistent with regulatory expectations.
Authority liaison
Simplimedica acts as your PRRC in communication with Competent Authorities. We coordinate responses, manage inquiries, and support interactions to maintain transparency and compliance.
Back-up coverage
Structured continuity ensures a qualified PRRC is always available to fulfill the role during absences. Our Person Responsible for Regulatory Compliance (PRRC) Services provide reliability and peace of mind for your compliance management.
Turn Complex Regulations into Clear Next Steps
From global registrations to remediation work and authorised representation, Simplimedica delivers full-spectrum regulatory support tailored to your goals. Get expert guidance every step of the way.
Who Needs PRRC Services?
Simplimedica’s Person Responsible for Regulatory Compliance (PRRC) Services are essential for:
- All manufacturers placing medical devices or IVDs on the EU market
- SMEs that may subcontract PRRC duties due to limited internal resources
- Companies seeking expert oversight without hiring full-time regulatory staff
The PRRC must possess the required qualifications, including a university degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline, plus at least one year of regulatory experience in medical devices. Alternatively, four years of professional experience in regulatory affairs or quality management systems are acceptable.
Engagement Process for Person Responsible for Regulatory Compliance (PRRC) Services
Simplimedica follows a structured approach to ensure smooth onboarding and compliance management:
Initial consultation
We review your organization structure, device classification, and QMS maturity to assess the regulatory landscape and identify needs.
Qualification verification
Our team verifies regulatory scope, technical documentation readiness, and ensures that the appointed PRRC meets all EU MDR/IVDR requirements.
Formal appointment
A service agreement is signed, appointing qualified individual(s) as your PRRC and defining their responsibilities within your organization.
Implementation
The PRRC is integrated with your QMS, and compliance oversight is established. Our team ensures technical documentation, vigilance processes, and regulatory reporting are fully managed.
Ongoing support
We provide regular reviews, vigilance coordination, and communication with authorities to maintain continuous compliance. Simplimedica’s Person Responsible for Regulatory Compliance (PRRC) Services ensure that your organization is always inspection-ready.
Pricing and Service Options
- Flat Annual Retainer: Designation and ongoing compliance oversight.
- Portfolio-Based Pricing: For multiple device families under the same QMS.
- On-Demand Advisory: Regulatory updates, CAPA reviews, and authority correspondence.
Our PRRC solutions are scalable, cost-effective, and tailored to the complexity of your product portfolio.
Frequently Asked Questions
Ready to appoint a PRRC? Contact our team at info@simplimedica.com to request a proposal and onboarding checklist.
Do we need both a PRRC and an Authorised Representative?
Yes. The PRRC ensures internal regulatory compliance, overseeing documentation, audits, and conformity. The Authorised Representative handles EU market representation and regulatory communication. Simplimedica can act as PRRC while coordinating with your authorised representative.
Where is Simplimedica’s PRRC based?
Simplimedica’s PRRC experts are based in Leeds, providing local and EU-wide regulatory support. This ensures timely guidance, fast compliance responses, and robust oversight of quality systems, technical documentation, and regulatory requirements across all operations.
How is the PRRC service documented
All PRRC activities are fully documented, including review processes, oversight actions, and compliance verifications. Documentation ensures audit readiness, transparency, and accountability, demonstrating that regulatory responsibilities are consistently managed according to MDR/IVDR standards.
Can Simplimedica act as PRRC for multiple entities?
Yes. Our Person Responsible for Regulatory Compliance (PRRC) Services in Leeds support multiple manufacturers while maintaining compliance and independence. Each client receives tailored regulatory oversight, ensuring consistent quality and regulatory standards without conflicts across all managed entities.
Ready to appoint a PRRC?
Contact our team at info@simplimedica.com to request a proposal and onboarding checklist.
Final Takeaway
Simplimedica’s Person Responsible for Regulatory Compliance (PRRC) services provide manufacturers with access to highly qualified regulatory professionals.
- SMEs gain expert oversight without the cost of a full-time hire.
- Established companies ensure continuous compliance with EU MDR/IVDR.
- Our PRRC services integrate with your QMS to maintain regulatory readiness, manage vigilance, and handle authority communications.
With Simplimedica, complex regulations become clear, actionable steps, and your business remains fully compliant in all EU markets.
Let’s Simplify Your PRRC Compliance Journey
Whether you are launching a new medical device, updating your technical documentation, or maintaining post-market surveillance, our experts are here to help.
Book a free consultation today to understand how Person Responsible for Regulatory Compliance (PRRC) services can streamline compliance, reduce risk, and provide ongoing regulatory support.
Simplimedica — EU Authorised Representative (EUAR) and UKRP
Simplimedica acts as your trusted EU Authorised Representative (EUAR) for the European Union (EU) and the United Kingdom (UKRP), enabling non‑local medical device manufacturers to meet local regulatory requirements under EU MDR and UK MDR/UKCA rules.
We provide a single point of contact for regulators, notified bodies and health authorities, and manage your local regulatory responsibilities with clarity and accountability.
Our AR Service
We help you meet compliance requirements and gain approvals across global markets with expert regulatory guidance.
Registration support
Assistance with Eudamed registration (where applicable), Basic UDI‑DI guidance and GB/NI device listing support.
Regulatory liaison
We act as the single local contact for Competent Authorities, Notified Bodies and economic operators.
Change control & supplier oversight
We help ensure any material changes to your product or manufacturing that affect regulatory status are communicated appropriately.
Document retention & access
We securely retain technical documentation and the Declaration of Conformity as required by EU MDR/UK MDR for the statutory timeframes and provide access when requested by authorities.
Official AR designation
We accept formal appointment and sign the required declarations to act as your EU Authorised Representative and/or UK Responsible Person.
Vigilance & incident reporting
Initial local coordination for post-market surveillance, safety reports and field safety corrective actions as required by EU MDR / UK regulations.
Audit & inspection readiness:
We prepare and support responses to local market inspections and information requests.
Turn Complex Regulations into Clear Next Steps
From global registrations to remediation work and authorised representation, Simplimedica delivers full-spectrum regulatory support tailored to your goals. Get expert guidance every step of the way.
Who needs an Authorised Representative?
Any medical device manufacturer that does not have a registered place of business within the EU/EEA (for EU market) or within Great Britain (for GB market) must appoint an Authorised Representative or UK Responsible Person respectively to place devices on the market. This is mandatory for conformity under EU MDR and for meeting UKCA requirements in Great Britain.
Why choose Simplimedica?
Experienced professionals
PRRCs with relevant scientific and regulatory qualifications, experienced in MDR/IVDR compliance and audits.
Secure document handling
Encrypted storage and controlled access for technical files, declarations and correspondence.
Practical compliance
We focus on pragmatic, audit‑ready solutions that fit medical device manufacturing timelines.
Local presence, global reach
Local representation in EU/EEA and Great Britain, with remote integration to your global quality system.
Integrated with your systems
Works seamlessly with your QMS, Authorised Representative and manufacturing operations.
Audit-ready processes
Clear documentation, version control and sign-off protocols aligned to MDR/IVDR Article 15.
Transparent pricing
Flexible subscription models based on your portfolio size and required oversight.
Trusted by innovators
Supporting early-stage med-tech start-ups, SMEs and global OEMs with scalable regulatory services.
How it works — our simple 4‑step process
Engage
We review your device portfolio, regulatory status and technical documentation.
Agree scope
We agree the appointed devices, jurisdictions (EU/UK/NI) and responsibilities.
Formal appointment
Signing of the Authorised Representative agreement and handover of the required documentation.
Ongoing support
Vigilance coordination, device registration assistance and inspection support.
Pricing & subscription
To support manufacturers of all sizes, Simplimedica offers a flexible and transparent pricing structure designed to match your regulatory needs. Whether you require essential EU/UK representation, ongoing portfolio management, or rapid-response regulatory support, our subscription models ensure predictable costs and reliable service. Each plan provides access to experienced regulatory professionals, streamlined communication, and consistent oversight of your compliance obligations—allowing you to focus on product development while we handle your market-entry and regulatory continuity.
- Flat annual fee for AR designation and document retention (enquire)
- Portfolio subscription for multiple device listings and active registration management.
- Ad hoc support hourly rate for incident response, inspections or additional regulatory projects.
Frequently Asked Questions
Ready to appoint a PRRC? Contact our team at info@simplimedica.com to request a proposal and onboarding checklist.
Do you act for both EU and UK markets?
What documents do you need from us?
Yes — if you are a non-EU manufacturer. The Authorised Representative ensures local representation, while the PRRC ensures regulatory compliance. Simplimedica can act as both.
Do you provide full regulatory submissions?
Yes, while our AR service focuses on local representation, vigilance and document retention. We also provide or coordinate additional regulatory services (e.g., technical file gap assessments, Eudamed registration support, clinical and PMCF advice).
How long does the appointment take?
Once the contract is signed and documents are received, most appointments and initial set‑ups are completed within 5–10 business days, depending on the complexity of the technical documentation and any outstanding issues.