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.
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.
We help you meet compliance requirements and gain approvals across global markets with expert regulatory guidance.
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.
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.
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.
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.
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.
Simplimedica acts as your PRRC in communication with Competent Authorities. We coordinate responses, manage inquiries, and support interactions to maintain transparency and compliance.
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.
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.
Simplimedica’s Person Responsible for Regulatory Compliance (PRRC) Services are essential for:
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.
Simplimedica follows a structured approach to ensure smooth onboarding and compliance management:
We review your organization structure, device classification, and QMS maturity to assess the regulatory landscape and identify needs.
Our team verifies regulatory scope, technical documentation readiness, and ensures that the appointed PRRC meets all EU MDR/IVDR requirements.
A service agreement is signed, appointing qualified individual(s) as your PRRC and defining their responsibilities within your organization.
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.
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.
Our PRRC solutions are scalable, cost-effective, and tailored to the complexity of your product portfolio.
Ready to appoint a PRRC? Contact our team at info@simplimedica.com to request a proposal and onboarding checklist.
 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.
 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.
 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.
 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.
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Contact our team at info@simplimedica.com to request a proposal and onboarding checklist.
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Simplimedica’s Person Responsible for Regulatory Compliance (PRRC) services provide manufacturers with access to highly qualified regulatory professionals.
With Simplimedica, complex regulations become clear, actionable steps, and your business remains fully compliant in all EU markets.
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 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.
We help you meet compliance requirements and gain approvals across global markets with expert regulatory guidance.
Assistance with Eudamed registration (where applicable), Basic UDI‑DI guidance and GB/NI device listing support.
We act as the single local contact for Competent Authorities, Notified Bodies and economic operators.
We help ensure any material changes to your product or manufacturing that affect regulatory status are communicated appropriately.
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.
We accept formal appointment and sign the required declarations to act as your EU Authorised Representative and/or UK Responsible Person.
Initial local coordination for post-market surveillance, safety reports and field safety corrective actions as required by EU MDR / UK regulations.
We prepare and support responses to local market inspections and information requests.
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.
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.
PRRCs with relevant scientific and regulatory qualifications, experienced in MDR/IVDR compliance and audits.
Encrypted storage and controlled access for technical files, declarations and correspondence.
We focus on pragmatic, audit‑ready solutions that fit medical device manufacturing timelines.
Local representation in EU/EEA and Great Britain, with remote integration to your global quality system.
Works seamlessly with your QMS, Authorised Representative and manufacturing operations.
Clear documentation, version control and sign-off protocols aligned to MDR/IVDR Article 15.
Flexible subscription models based on your portfolio size and required oversight.
Supporting early-stage med-tech start-ups, SMEs and global OEMs with scalable regulatory services.
We review your device portfolio, regulatory status and technical documentation.
We agree the appointed devices, jurisdictions (EU/UK/NI) and responsibilities.
Signing of the Authorised Representative agreement and handover of the required documentation.
Vigilance coordination, device registration assistance and inspection support.
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.
Ready to appoint a PRRC? Contact our team at info@simplimedica.com to request a proposal and onboarding checklist.
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.
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).Â
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.Â