Updated: 6th June 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder & CEO)
Person Responsible for Regulatory Compliance (PRRC)
The introduction of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) fundamentally changed the compliance landscape by introducing a mandatory, highly scrutinized role: the Person Responsible for Regulatory Compliance (PRRC).
Under Article 15, manufacturers and Authorized Representatives must have a qualified PRRC permanently and continuously at their disposal to ensure that the supervision, control, and post-market safety of devices are actively managed within the organization. As European Competent Authorities and Notified Bodies tighten their auditing standards, understanding the exact boundaries of this role is critical to maintaining market access.
New to the EU MDR?
The Person Responsible for Regulatory Compliance (PRRC) is a key requirement under Regulation (EU) 2017/745. For a complete overview of MDR requirements, including classification, Article 10 obligations, GSPRs, technical documentation, UDI, EUDAMED and CE marking, explore our EU MDR for Beginners Guide.
Working with In Vitro Diagnostic Medical Devices?
The Person Responsible for Regulatory Compliance (PRRC) is also a legal requirement under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. For a complete overview of IVDR requirements, including device classification, Article 10 obligations, performance evaluation, technical documentation, post-market performance follow-up (PMPF) and CE marking, explore our IVDR for Beginners Guide.
Do I Need a Person Responsible for Regulatory Compliance (PRRC)?
Whether you need to appoint a Person Responsible for Regulatory Compliance (PRRC) depends on your role within the medical device supply chain. Under Article 15 of the EU Medical Device Regulation (EU MDR 2017/745) and Article 15 of the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), manufacturers and authorised representatives are legally required to have a suitably qualified PRRC permanently and continuously at their disposal. Importers and distributors do not have this obligation, although they have their own regulatory responsibilities under the Regulations.
The table below summarises when a PRRC is required.
| Organisation | PRRC Required? | Explanation |
|---|---|---|
| EU medical device manufacturer | ✅ Yes | Every manufacturer placing devices on the EU market must appoint a suitably qualified PRRC. |
| Non-EU medical device manufacturer | ✅ Yes | Manufacturers outside the EU must also have a PRRC available, regardless of where they are located. |
| EU Authorised Representative | ✅ Yes | Every authorised representative must have its own PRRC under Article 15. |
| Importer | ❌ No | Importers have responsibilities under Article 13 but are not required to appoint a PRRC. |
| Distributor | ❌ No | Distributors must meet Article 14 obligations but do not require a PRRC. |
| Contract manufacturer | ⚠️ Depends | If acting as the legal manufacturer, a PRRC is required. If only manufacturing on behalf of another legal manufacturer, the obligation usually rests with the legal manufacturer. |
| System or Procedure Pack Producer (Article 22) | ⚠️ Depends | A PRRC is not automatically required, but may be necessary if the organisation also acts as a legal manufacturer or authorised representative. |
Key Takeaway
If your organisation is the legal manufacturer of a medical device or IVD, or you act as an EU Authorised Representative, appointing a suitably qualified PRRC is a legal requirement under Article 15. Importers and distributors do not need a PRRC, although they remain responsible for complying with their own obligations under the EU MDR and IVDR.
Mandatory PRRC Qualifications & Experience Standards
To step into the role of a PRRC, an individual must possess requisite expertise in the field of medical devices or in vitro diagnostic medical devices. As outlined in Article 15(1), this expertise must be formally proven through one of two pathways:
The Academic Pathway: A formal university degree, diploma, or recognized equivalent course of study in law, medicine, pharmacy, engineering, or a relevant scientific discipline, combined with at least one year of professional experience in regulatory affairs or quality management systems (QMS) relating to medical devices or IVDs.
The Experience Pathway: A minimum of four years of substantive professional experience in regulatory affairs or QMS within the medical device or IVD sector.
The Standard for Valid Experience
The Medical Device Coordination Group clarified in its md_mdcg_2019_7_guidance document that professional experience must be substantive and recent.
⚠️ Audit Warning: The guidance explicitly states that experience limited to the administrative handling of documents or merely shadowing regulatory affairs professionals will not be considered sufficient. Manufacturers must maintain robust evidence of their PRRC’s practical capabilities—such as detailed CVs and training certificates—as Competent Authorities frequently request these during market surveillance inspections.
2026 Audit Focus Alert:
Notified Bodies are actively verifying the "permanently and continuously at their disposal" requirement for outsourced PRRCs. Your contractual agreement must explicitly define their operational availability, swift response times for vigilance reporting, and proof that they are not over-allocated to too many legal entities.
Outsourcing Guidelines for Micro and Small Businesses
Recognizing that small companies may lack the resources for a full-time, in-house regulatory executive, Article 15(2) offers a vital lifeline for micro and small enterprises (companies with fewer than 50 employees and an annual turnover/balance sheet under €10 million). These entities are not required to have the PRRC directly within their organization but must have them “permanently and continuously at their disposal.”
This allows smaller manufacturers to subcontract the PRRC role to an external third-party expert. However, this setup is under intense audit scrutiny.
What Your PRRC Contract Must Contain
To satisfy a Notified Body, your contract with an external PRRC must be explicit. The MDCG 2019-7 Guidance framework notes that the contract must define how continuous availability is realistically achieved. It clarifies that while the PRRC must be available to perform operational duties and react in a timely manner (especially during vigilance or recall events), it does not legally imply a 24-hour daily availability.
The contract must also clearly document that the designated individual meets the precise qualification criteria under Article 15(1).
Need a Fully Compliant, Outsourced PRRC?
Navigating the strict boundaries of MDCG 2019-07 Rev. 1 requires more than just a signature. Your outsourced PRRC must have substantive, recent experience, ensure continuous availability, and maintain total independence from your Authorized Representative to pass Notified Body scrutiny.
At Patient Guard, we provide dedicated, highly qualified Article 15 PRRC services tailored specifically to micro and small medical device and IVD manufacturers.
Explore Our Dedicated PRRC Services →Deep Dive: The Five Statutory Responsibilities of a PRRC
Under Article 15(3) of the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), the Person Responsible for Regulatory Compliance (PRRC) has five specific legal responsibilities. These duties ensure that regulatory compliance is maintained throughout the entire product lifecycle, from product release through to post-market surveillance.
1. Verify Product Conformity Before Release
Before a medical device or IVD is placed on the market, the PRRC must ensure that the appropriate conformity assessment procedures have been completed in accordance with the manufacturer’s Quality Management System (QMS).
This includes confirming that:
- Technical documentation has been completed and approved.
- Required testing and verification activities have been successfully completed.
- Design changes have been appropriately reviewed and documented.
- The device complies with the applicable requirements of the MDR or IVDR before release.
The PRRC should have confidence that the manufacturer has sufficient objective evidence to demonstrate compliance.
Need Help Structuring Your Technical Documentation?
A compliant Technical File is one of the PRRC's key areas of oversight under Article 15 of the EU MDR. Learn how to structure your technical documentation in accordance with Annexes II and III of Regulation (EU) 2017/745 in our Medical Device Technical File Guide.
2. Ensure Technical Documentation and the Declaration of Conformity Are Maintained
The PRRC is responsible for ensuring that the manufacturer’s Technical Documentation and EU Declaration of Conformity have been prepared correctly and are kept up to date throughout the product lifecycle.
This includes ensuring that documentation is reviewed whenever there are changes to:
- Device design
- Intended purpose
- Applicable standards
- Clinical evidence
- Risk management
- Regulatory requirements
Maintaining accurate documentation is essential for demonstrating ongoing compliance during Competent Authority inspections and Notified Body audits.
3. Oversee the Post-Market Surveillance System
Regulatory compliance does not end when a device is CE marked. The PRRC must ensure that the manufacturer’s Post-Market Surveillance (PMS) system is functioning effectively and continues to collect information about device performance once products are on the market.
This includes reviewing information from:
- Customer complaints
- Incident reports
- Trend analysis
- Literature reviews
- PMCF or PMPF activities where applicable
- Corrective and preventive actions (CAPA)
The objective is to identify emerging risks and ensure continuous compliance throughout the device lifecycle.
Need a Better Understanding of Post-Market Surveillance?
Post-Market Surveillance (PMS) is one of the PRRC's key responsibilities under the EU MDR and IVDR. Learn how to develop compliant PMS Plans, PMS Reports, PSURs, PMCF activities and vigilance processes in our Medical Device Post-Market Surveillance Guide.
4. Ensure Vigilance Reporting Requirements Are Met
The PRRC must oversee the manufacturer’s vigilance processes to ensure that serious incidents and Field Safety Corrective Actions (FSCAs) are reported to the appropriate Competent Authorities within the required regulatory timeframes.
This includes ensuring appropriate procedures exist for:
- Incident investigation
- Root cause analysis
- Trend reporting
- FSCA management
- Regulatory communications
Timely vigilance reporting is a key requirement under both the MDR and IVDR.
5. Verify Compliance for Clinical Investigations and Performance Studies
Where a manufacturer conducts clinical investigations (MDR) or clinical performance studies (IVDR), the PRRC must ensure that the regulatory statements required under the Regulations have been completed before the study begins.
This helps demonstrate that the manufacturer has taken appropriate measures to protect the rights, safety and wellbeing of study participants while complying with the applicable regulatory requirements.
The PRRC's Duty to Escalate
The PRRC is not expected to simply identify compliance issues—they are also expected to escalate them. MDCG 2019-07 Rev. 1 explains that if the organisation fails to provide the information, resources or support needed for the PRRC to fulfil their legal responsibilities, the PRRC should formally notify senior management.
This ensures that significant compliance risks are brought to the attention of company leadership and that appropriate corrective actions can be taken before they develop into regulatory non-conformities or patient safety issues.
Strict Separation of Roles: Preventing Conflicts of Interest
One of the most vital compliance guardrails reaffirmed by the MDCG is the absolute independence required between a manufacturer and its European Authorized Representative (AR).
Can one individual act as the PRRC for a non-EU manufacturer and its Authorized Representative? No.
Even if the non-EU manufacturer and the AR belong to the exact same parent company or large corporate organization, they cannot share a PRRC. The regulations deliberately demand that the AR adds an independent, additional layer of scrutiny over the manufacturer’s compliance, vigilance, and post-market tracking. Allowing the same person or the same external consulting firm to hold both roles completely hollows out this regulatory check-and-balance system.
Crucial Rule for Outsourcing: The PRRC of a micro or small enterprise and the PRRC of that enterprise’s Authorized Representative shall not belong to the same external organization
Eudamed Registration and the Strict 7-Day Rule
Once a PRRC is appointed, their compliance lifecycle is tracked publicly. Under Article 31 (MDR) and Article 28 (IVDR), manufacturers and authorized representatives are legally mandated to enter their PRRC’s name, legal address, and direct contact details into the Eudamed database.
The Compliance Clock: If you change your PRRC, terminate a subcontracting agreement, or if your PRRC’s contact details change, you must update this information in Eudamed within one week. This tight window means regulatory managers must have their documentation completely finalized before making operational organizational shifts.
Financial Outlook & 2026 Talent Market Realities
The medical device regulatory sector faces a continuous shortage of qualified talent, which has significantly driven up recruitment and overhead costs for in-house positions. For companies insisting on hiring a full-time, in-house Article 15 specialist in the UK, current base salary expectations generally span the following brackets:
For many small to mid-sized manufacturers, these salary requirements—combined with the legal liabilities the PRRC faces—make outsourcing the role to an established regulatory consultancy the most financially predictable and legally compliant path forward.
In-House vs Outsourced PRRC: Which Is Right for Your Organisation?
The EU MDR does not require every manufacturer to employ a full-time Person Responsible for Regulatory Compliance (PRRC). For many organisations, particularly small and medium-sized enterprises (SMEs), outsourcing the role can provide access to experienced regulatory professionals while remaining fully compliant with Article 15.
Whether you appoint an in-house employee or engage an external consultant, the key requirement is that the PRRC possesses the necessary qualifications and experience and is permanently and continuously at the organisation’s disposal.
The table below compares the two approaches.
| In-House PRRC | Outsourced PRRC |
|---|---|
| Full-time employee | Independent regulatory specialist |
| Recruitment and employment costs | Predictable consultancy or retainer fee |
| Ongoing training required to maintain regulatory knowledge | Immediate access to current MDR and IVDR expertise |
| Experience limited to one organisation | Broad experience across multiple manufacturers and device types |
| Holiday, sickness and staff turnover can affect availability | Continuity of support through an established consultancy |
| Additional overheads such as pensions, benefits and recruitment | No recruitment or employment administration |
| Suitable for larger organisations with dedicated regulatory teams | Often ideal for SMEs and manufacturers with limited internal regulatory resources |
When Can a PRRC Be Outsourced?
Article 15 specifically allows manufacturers that qualify as small and medium-sized enterprises (SMEs) to have a PRRC permanently and continuously at their disposal without employing them directly. This enables suitably qualified external consultants to fulfil the role, provided they remain available to carry out the legal responsibilities defined by the MDR.
Outsourcing can also be an effective solution for organisations that:
- Do not have an experienced regulatory professional in-house.
- Require additional expertise during periods of business growth.
- Need temporary cover during recruitment or staff absence.
- Want independent regulatory oversight to support ongoing compliance.
- Require specialist knowledge across multiple regulatory frameworks.
Regardless of whether the PRRC is employed internally or engaged externally, manufacturers remain responsible for ensuring the individual has the authority, resources and access needed to fulfil their legal obligations under Article 15.
Can One Person Act as the PRRC for Multiple Companies?
Yes. In many cases, a suitably qualified individual can act as the Person Responsible for Regulatory Compliance (PRRC) for more than one organisation. This is particularly common where experienced regulatory consultants provide outsourced PRRC services to multiple manufacturers.
However, Article 15 of the EU MDR does not permit a PRRC to be appointed in name only. Every manufacturer must ensure that their PRRC is permanently and continuously at their disposal, meaning the individual must have sufficient availability, authority and access to fulfil all of their legal responsibilities.
What Does "Permanently and Continuously at Their Disposal" Mean?
The European Commission’s guidance (MDCG 2019-07 Rev. 1) explains that the PRRC must be available whenever regulatory oversight is required. This does not necessarily mean the individual must be employed full-time by the manufacturer, but they must be able to:
- Review and oversee regulatory documentation.
- Support product release activities.
- Participate in post-market surveillance and vigilance activities.
- Advise on regulatory changes and compliance decisions.
- Be available during Competent Authority inspections or Notified Body audits where appropriate.
Demonstrating Sufficient Capacity
Where a PRRC supports multiple organisations, they should be able to demonstrate that they have sufficient capacity to effectively fulfil the role for each client.
Factors that may be considered include:
- The number of manufacturers supported.
- The number and complexity of medical devices or IVDs.
- Device classifications.
- The manufacturer’s size and regulatory workload.
- The availability of additional regulatory support where required.
If the PRRC is responsible for more organisations than can reasonably be supported, this may be challenged during a Notified Body audit or Competent Authority inspection.
The Importance of Clear Contractual Arrangements
Where an external consultant acts as the PRRC, the appointment should be supported by a written agreement that clearly defines:
- The scope of the PRRC’s responsibilities.
- Availability and response times.
- Access to the manufacturer’s Quality Management System and Technical Documentation.
- Responsibilities for post-market surveillance and vigilance activities.
- Reporting arrangements with senior management.
Clear contractual arrangements help demonstrate that the PRRC is genuinely integrated into the manufacturer’s regulatory processes rather than acting as a nominal appointment.
Factors that may be considered include:
- The number of manufacturers supported.
- The number and complexity of medical devices or IVDs.
- Device classifications.
- The manufacturer’s size and regulatory workload.
- The availability of additional regulatory support where required.
If the PRRC is responsible for more organisations than can reasonably be supported, this may be challenged during a Notified Body audit or Competent Authority inspection.
Practical Example
A regulatory consultancy may provide outsourced PRRC services to several small medical device manufacturers. This arrangement is entirely acceptable, provided each manufacturer can demonstrate that the PRRC has sufficient time, resources and authority to perform the duties required under Article 15. Simply appointing the same individual across numerous organisations without ensuring adequate capacity would not satisfy the intent of the Regulation.
Key Point: A PRRC can support multiple organisations, but only where they remain permanently and continuously available to each manufacturer and have sufficient capacity to carry out their legal responsibilities effectively.
Need an Outsourced PRRC?
Patient Guard provides fully qualified outsourced PRRC services for medical device and IVD manufacturers under Article 15 of EU MDR and IVDR. We help organisations demonstrate continuous regulatory oversight, maintain compliant technical documentation, support post-market surveillance and prepare for Notified Body audits.
Frequently Asked Questions About PRRC
Yes. Under Article 15 of the EU MDR and IVDR, micro and small enterprises (SMEs) may appoint an external Person Responsible for Regulatory Compliance (PRRC), provided the individual is permanently and continuously at the organisation's disposal. The outsourced PRRC must possess the required qualifications and have sufficient authority and availability to fulfil all legal responsibilities.
Yes. A suitably qualified PRRC may support multiple manufacturers, particularly when acting as an external regulatory consultant. However, they must be able to demonstrate that they have sufficient capacity, resources and availability to effectively fulfil their responsibilities for each organisation. Manufacturers should also have clear contractual arrangements defining the PRRC's role.
The PRRC requirement applies to manufacturers placing medical devices or IVDs on the European Union market under the EU MDR or IVDR. Manufacturers placing products only on the Great Britain market are not currently required to appoint a PRRC under UK medical device legislation. However, organisations marketing devices in both Great Britain and the EU must comply with the applicable requirements in each jurisdiction.
The PRRC has specific legal responsibilities under Article 15, but the overall legal responsibility for regulatory compliance remains with the manufacturer. While the PRRC is accountable for carrying out their duties competently, the manufacturer remains responsible for ensuring that compliant devices are placed on the market and that adequate resources are provided to support regulatory compliance.
Yes. Experienced regulatory consultants can act as outsourced PRRCs where permitted by Article 15. This is a common solution for small and medium-sized manufacturers that do not have sufficient internal regulatory resources. The consultant must meet the qualification requirements and remain permanently and continuously available to the manufacturer.
Yes. A Quality Manager may also perform the PRRC role, provided they meet the education and experience requirements defined in Article 15 and have sufficient authority within the organisation to fulfil all statutory responsibilities. Many smaller manufacturers combine these responsibilities into a single role.
Manufacturers should formally appoint the PRRC through documented procedures, employment contracts or consultancy agreements. The appointment should clearly define the individual's responsibilities, reporting arrangements and authority within the Quality Management System. Evidence of the PRRC's qualifications and ongoing involvement should also be maintained.
No. ISO 13485 does not specifically require organisations to appoint a Person Responsible for Regulatory Compliance. The PRRC is a legal requirement introduced by Article 15 of the EU MDR and IVDR. However, many organisations integrate the PRRC role within their ISO 13485 Quality Management System to help ensure ongoing regulatory compliance.
Manufacturers should retain documented evidence demonstrating compliance with Article 15, including:
- Appointment letters or consultancy agreements.
- Curriculum vitae and qualification records.
- Training records.
- Job descriptions.
- Evidence of participation in management reviews.
- Technical documentation approvals.
- Post-market surveillance and vigilance activities.
- Records demonstrating ongoing regulatory oversight.
Maintaining comprehensive records helps demonstrate compliance during Competent Authority inspections and Notified Body audits.
Failure to appoint a PRRC where required represents non-compliance with Article 15 of the EU MDR or IVDR. During a Notified Body audit or Competent Authority inspection, this may result in regulatory findings requiring corrective action and could delay certification or market access. Manufacturers should ensure a suitably qualified PRRC is appointed before placing devices on the EU market.
References
This guide is based on the following legislation and official regulatory guidance relating to the Person Responsible for Regulatory Compliance (PRRC) under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Contains Article 15, which establishes the requirement for manufacturers and Authorised Representatives to have a suitably qualified Person Responsible for Regulatory Compliance permanently and continuously at their disposal. |
| European Union | Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) | Establishes equivalent PRRC requirements for manufacturers and Authorised Representatives of in vitro diagnostic medical devices, including qualifications and statutory responsibilities. |
| Medical Device Coordination Group (MDCG) | MDCG 2019-7 Rev.1 – Guidance on Article 15 and the Person Responsible for Regulatory Compliance | Provides dedicated guidance on PRRC qualifications, professional experience, responsibilities, outsourcing arrangements, continuous availability, Authorised Representative PRRCs and the separation of potentially conflicting roles. |
| European Commission | EUDAMED Actor Registration Module | Provides official information on registering manufacturers, Authorised Representatives and other economic operators in EUDAMED, obtaining a Single Registration Number and maintaining actor information. |
| European Union | Commission Recommendation 2003/361/EC – Definition of Micro, Small and Medium-Sized Enterprises | Defines the company-size thresholds used to determine whether a manufacturer qualifies as a micro or small enterprise for the purposes of the external PRRC arrangements permitted by Article 15. |
PRRC requirements and regulatory guidance continue to evolve. Manufacturers and Authorised Representatives should always consult the latest published legislation and official guidance when appointing a PRRC, defining contractual arrangements and demonstrating ongoing compliance with Article 15 of the MDR or IVDR.
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