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 MDR/IVDR qualification criteria, appointed formally as your external PRRC.
Review of changes affecting conformity, vigilance coordination and adverse-event escalation.
Verification that your QMS continues to comply with MDR/IVDR and ISO 13485 expectations.
Communication and response to Competent Authority inquiries in coordination with the manufacturer or Authorised Representative.
Structured continuity ensuring a qualified PRRC is always available to fulfil the role during absences.
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.
Under Article 15 of EU MDR and IVDR:
Review of organisation structure, device classification and QMS maturity.
Ensuring regulatory scope and technical documentation readiness.
Signing of PRRC service agreement, designation of qualified individual(s) and definition of responsibilities.
Integration with QMS, document review and compliance oversight setup.
Regular reviews, vigilance coordination and authority communication.
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.
Our designated PRRCs are located within the EU, satisfying the requirement that the PRRC be physically established in the Union.
We issue a formal appointment letter and maintain documented procedures outlining the PRRC’s role and responsibilities in accordance with MDR/IVDR Article 15.
Yes, provided appropriate independence, confidentiality, and conflict-of-interest controls are in place.
Contact our team at info@simplimedica.com to request a proposal and onboarding checklist.
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).
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.
