Person Responsible for Regulatory Compliance (PRRC)
A Person Responsible for Regulatory Compliance (PRRC) is the qualified individual that device manufacturers and EU authorised representatives must have under Article 15 of EU MDR 2017/745 and EU IVDR 2017/746. This guide explains the rules, duties and requirements, and how I3CGLOBAL can provide a qualified PRRC.
The basics
What Is a Person Responsible for Regulatory Compliance?
A person responsible for regulatory compliance is a named, qualified individual who makes sure key EU device obligations are met. The role is set by Article 15 of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
The Medical Device Coordination Group explains the role in MDCG 2019-7 Rev.1, dated December 2023. The guidance is not law, but it shows how EU authorities read Article 15. Recital 34 of the MDR and Recital 33 of the IVDR describe the purpose: a person within the organisation with responsibility for compliance and a minimum level of expertise.
This person does not replace the manufacturer. The manufacturer remains responsible for demonstrating conformity, and this person is responsible for the activities listed in Article 15(3).
Who needs one
Who Must Appoint a PRRC?
Article 15 applies to more parties than many companies expect. Use this table to check whether you need a person responsible for regulatory compliance and in what form.
| Organisation | Requirement | Key Point |
|---|---|---|
| Manufacturer (medium or large) | At least one person within the organisation. | Each legal manufacturer in a group needs its own appointee. |
| Micro or small manufacturer | A person permanently and continuously at its disposal. | The person need not sit within the organisation (Article 15(2)). |
| EU authorised representative | A person permanently and continuously at its disposal (Article 15(6)). | The person must be located in the EU and cover the mandate tasks in Article 11(3). |
| Importer or distributor assuming manufacturer obligations | Required when Article 16(1) applies. | Triggers: own-name supply, a changed intended purpose, or a modification that may affect compliance. |
| Party under MDR Article 17 or 22(4) | Required, as the party assuming the manufacturer role. | Covers reprocessing of single-use devices and certain systems and procedure packs. |
| Custom-made device manufacturer | Required, with an alternative experience route. | Non-EU manufacturers still need an EU authorised representative with a PRRC. |
An ordinary importer or distributor that does not trigger Article 16(1) keeps its own duties under Articles 13 and 14, but Article 15 does not apply to it directly. A company that sells a device under its own name is normally the legal manufacturer, even when another company makes the device, so it should plan for this role as part of CE marking or IVD CE marking.
Medical devices
PRRC for Medical Device Facilities
A medical device manufacturer needs this role under Article 15 of the MDR. The obligation attaches to the legal manufacturer, while MDCG 2019-7 Rev.1 expects a close, continuous link with manufacturing activities. The person should therefore understand how each facility produces, releases and monitors devices.
- Release: check that release follows the quality system at the facility.
- Documentation: keep technical documentation and the EU declaration of conformity current under Annexes II, III and IV.
- Post-market: make sure surveillance, PMCF and PSUR activities run as applicable.
- Vigilance: make sure serious incidents and field safety corrective actions are reported under Articles 87 to 91.
- Clinical investigations: make sure the Annex XV statement is issued for investigational devices.
Custom-made device manufacturers have a separate experience route, and parties under Article 17 or Article 22(4) should check their own position.
IVDs
PRRC for IVD Manufacturing Facilities
IVD manufacturers need the same role under Article 15 of the IVDR, but the experience must relate to in vitro diagnostic medical devices. Experience gained only with other device types should be assessed carefully before appointment.
- Release: check conformity under the quality system required by Article 10(8).
- Documentation: keep IVDR technical documentation and the declaration of conformity current.
- Post-market: make sure surveillance, PMPF and PSUR activities run as applicable.
- Vigilance: make sure the reporting obligations in Articles 82 to 86 are fulfilled.
- Performance studies: make sure the Annex XIV, Section 4.1 statement is issued where it applies.
Our IVDR consultants support IVD manufacturers with these requirements, subject to the location expectations described below.
Responsibilities
What Are the 5 Statutory PRRC Duties?
Article 15(3) lists what the person responsible for regulatory compliance must make sure of. The MDR reference comes first, with the IVDR reference in brackets where it differs.
- Conformity check before releaseDevice conformity is appropriately checked under the quality management system before release. See Article 10(9) [10(8)].
- Technical documentation and declarationThe technical documentation and EU declaration of conformity are drawn up and kept up to date. See Articles 10(4) and 10(6) [10(5)].
- Post-market surveillancePost-market surveillance obligations are met in line with Article 10(10) [10(9)] and Article 83 [78].
- Vigilance reportingThe reporting obligations in Articles 87 to 91 [82 to 86] are fulfilled, including vigilance for incidents and field safety corrective actions.
- Investigational device statementFor investigational devices, the Annex XV, Chapter II, Section 4.1 statement is issued. The IVDR equivalent is Annex XIV, Section 4.1, for the performance studies it covers.
The wording matters. The duty is to make sure these things happen, so this person does not have to write every document or file every report. Other qualified staff can carry out the work, as long as the quality management system defines it and the appointed person can verify it. MDCG 2019-7 Rev.1 gives the example of verifying that devices for release have followed procedures.
What additional activities can a PRRC support?
The activities below are operational support agreed in the job description or contract. They are not additional statutory duties under Article 15(3).
Regulatory compliance
Monitor compliance with applicable EU MDR and IVDR requirements.
Quality management
Monitor relevant QMS activities, including CAPA, change control and non-conformity management.
Regulatory audits
Support Notified Body audits and regulatory inspections.
Management reporting
Report significant regulatory compliance issues to management.
PMS outputs
Monitor PMS, PMCF or PMPF and PSUR activities, as applicable.
Qualifications
What Qualifications Does a PRRC Need?
Article 15 sets expertise routes for the person responsible for regulatory compliance. Experience should relate to EU device requirements, and MDCG 2019-7 Rev.1 expects it to be substantive and recent.
| Route | Formal Qualification | Experience Required |
|---|---|---|
| Degree route | University degree, or a course recognised as equivalent by a Member State, in law, medicine, pharmacy, engineering or another relevant scientific discipline. | At least one year in regulatory affairs or quality management systems for medical devices or IVDs, as applicable. |
| Experience route | Not required. | Four years in regulatory affairs or quality management systems for medical devices or IVDs, as applicable. |
| Custom-made devices (MDR) | Not required. | At least two years within a relevant field of manufacture, covering regulatory or QMS aspects. |
What evidence should you keep on file?
- Degree or diploma certificates, plus any equivalence recognition
- A dated CV showing regulatory or QMS experience with devices
- Records of EU MDR or IVDR project work, training and audits
- A signed appointment or contract stating duties and authority
- A written job description linked to your quality system
Article 15 does not require a named certificate. Training helps, but it does not replace the qualification and experience above.
Outsourcing
Which Manufacturers Can Use an Outsourced PRRC?
Yes, within limits. Micro and small enterprises are defined in Commission Recommendation 2003/361/EC. Under Article 15(2) they need not have a person responsible for regulatory compliance within the organisation, but must have one permanently and continuously at their disposal.
Micro enterprise
Fewer than 10 staff, with annual turnover or balance sheet total of up to EUR 2 million. An external appointee is allowed.
Small enterprise
Fewer than 50 staff, with annual turnover or balance sheet total of up to EUR 10 million. An external appointee is allowed.
Medium or large company
Above those limits. The person must be available within the organisation, so I3CGLOBAL can provide qualified personnel for employment within the organisation instead.
MDCG 2019-7 Rev.1 says a contract should state the qualifications of the external person, and the manufacturer must be able to document compliance. “Permanently and continuously” does not mean 24-hour cover. It means the person can act in a timely manner when needed.
The enterprise limits depend on group links too, so check partner and linked companies before you rely on the micro or small enterprise status.
Location
Where Should Your PRRC Be Located?
The Regulations do not set a location for this person, but MDCG 2019-7 Rev.1 expects a close linkage of a permanent and continuous nature with manufacturing. This leads to the following assumptions about a person responsible for regulatory compliance:
| Manufacturer Location | PRRC Location Expected Under MDCG Guidance |
|---|---|
| EU | Within the EU. |
| USA | Outside the EU, preferably close to manufacturing activities. |
| UK | Outside the EU, preferably close to manufacturing activities. |
| India | Outside the EU, preferably close to manufacturing activities. |
| EU authorised representative (separate role) | Within the EU. |
A non-EU manufacturer therefore usually has two separate roles: its own appointee close to manufacturing, and a second appointee at its EU authorised representative. The guidance is less direct for micro and small enterprises outside the EU, so record your reasoning when you decide on the arrangement.
Comparison
How Does a PRRC Differ From an Authorised Representative?
The two terms are often confused. One is an individual, and the other is a legal or natural person mandated by a non-EU manufacturer.
| Point | PRRC | EU Authorised Representative |
|---|---|---|
| What it is | A qualified individual. | A natural or legal person in the EU, with a written mandate. |
| Legal basis | Article 15. | Article 11. |
| Who needs it | Manufacturers, authorised representatives and parties assuming manufacturer obligations. | Manufacturers established outside the EU. |
| Main focus | Release checks, documentation, surveillance and reporting. | Verification and cooperation tasks listed in the mandate. |
| Can they be the same? | The PRRC of a non-EU manufacturer cannot also be the PRRC of its authorised representative. | An authorised representative must have its own appointee at its disposal. |
For a micro or small enterprise, MDCG 2019-7 Rev.1 also says its appointee and the appointee of its representative cannot come from the same external organisation. Plan both roles together when you review the cost of an EU authorised representative.
Organisation
Can a Company Have More Than One PRRC?
Yes. Article 15(1) asks for at least one person, and Article 15(4) says that where several people are jointly responsible, their areas of responsibility must be stipulated in writing. One may cover release checks while another covers technical documentation.
Practical points for groups and multiple sites
- Each legal manufacturer in a group needs its own person responsible for regulatory compliance, as stated in MDCG 2019-7 Rev.1.
- Size the role to the device range and risk class. This is a practical planning approach, not a fixed rule in Article 15.
- Avoid leaving a duty unassigned or giving it to two people without a clear lead.
- Define deputies and handovers, so the role stays covered during leave or staff changes.
Quality system
How Does the PRRC Fit With the QMS and Remain Protected?
Article 10(9) of the MDR and Article 10(8) of the IVDR require a quality management system that is proportionate to the risk class and type of device. The role should be built into that system, and it often sits alongside ISO 13485 certification processes.
Article 15(5) adds an important protection: the PRRC must not suffer any disadvantage for properly fulfilling their duties, whether or not they are an employee. MDCG 2019-7 Rev.1 gives examples such as dismissal or penalisation, and says anyone in the role who cannot meet the obligations should inform the manufacturer.
What should your procedure cover?
- Appointment, qualification checks and replacement
- How the appointed person verifies release, documentation and reporting
- Access to records, management and the data needed for the role
- Escalation when a duty cannot be met
- Periodic review of the arrangement, including at management review
Registration
Must a PRRC Be Registered in EUDAMED?
Yes. Article 31 of the MDR and Article 28 of the IVDR require manufacturers and authorised representatives to provide the name, address and contact details of the person responsible for regulatory compliance. MDCG 2019-7 Rev.1 notes that changes must be updated within one week.
Commission Decision (EU) 2025/2371 made the EUDAMED Actor module, along with the UDI/Device, Notified Bodies and Certificates, and Market Surveillance modules, mandatory from 28 May 2026. Our EUDAMED registration guide explains the process. Keep the entry aligned with your appointment records.
Regulatory watch
Are Changes to Article 15 Proposed?
Yes. In December 2025 the European Commission published proposal COM(2025) 1023 to revise the MDR and IVDR. Its explanatory memorandum says the change would remove the detailed PRRC qualification requirements. It would also remove the requirement that SMEs keep an external PRRC permanently and continuously available, so that the person need only be available.
Common gaps
What PRRC Gaps Should You Look For?
These are practical checks you can run against your current arrangement for the person responsible for regulatory compliance:
- Experience is general quality work, with no link to EU device requirements
- No evidence on file of the degree, experience or appointment
- An outsourced appointee used by a company above the micro or small limits
- No contract, or a contract that does not state the qualifications
- The same person named for a non-EU manufacturer and its authorised representative
- Several appointees with no written split of responsibility
- Duties not reflected in the QMS, or no record that release checks took place
- EUDAMED details out of date after a change of person
- An appointee with no access to vigilance, complaint or post-market data
A short internal audit can test each point. Your vigilance control records and release records are useful places to start, because they show whether the role works in practice.
Our PRRC service
Hire a PRRC
Now that the requirements are clear, here is how we can help. I3CGLOBAL provides qualified PRRC professionals to medical device and IVD manufacturers seeking EU MDR 2017/745 and EU IVDR 2017/746 compliance. We provide an actual, qualified person who can be appointed as your PRRC, not general regulatory advice alone, for manufacturers applying for or maintaining certification.
Our professionals support technical documentation compliance, product conformity verification, post-market surveillance, vigilance reporting and ongoing regulatory compliance activities. Depending on the size, location and regulatory requirements of the manufacturer, we offer outsourced PRRC arrangements or qualified personnel for placement within the manufacturer’s organisation.
Arrangements
Should You Choose an Outsourced or Dedicated PRRC?
The right arrangement depends mainly on company size, because Article 15 treats micro and small enterprises differently from larger manufacturers.
| Service | Arrangement | Suitable For |
|---|---|---|
| Outsourced PRRC | Monthly or annual contractual appointment. | Eligible micro and small manufacturers (Article 15(2)). |
| Dedicated PRRC personnel | Full-time or part-time qualified personnel supplied by I3CGLOBAL and employed within the manufacturer’s organisation. | Medium and large manufacturers, which must have this person within their organisation. |
Each legal manufacturer must have its own appointee, so a group with several legal manufacturers should plan one appointment for each. These conditions are explained in MDCG 2019-7 Rev.1.
Who we support
Which Manufacturers Does I3CGLOBAL Support?
Our main focus is manufacturers in Europe and the USA. Our professionals are located according to your location and the requirements that apply to you.
Manufacturers in Europe
MDCG 2019-7 Rev.1 expects an EU manufacturer to have its appointee within the EU. We can provide professionals in Europe for medical device and IVD manufacturers, as an outsourced appointment for eligible micro and small companies or as personnel placed within larger organisations.
Manufacturers in the USA
A US manufacturer entering the European market is expected to have its appointee outside the EU, preferably close to manufacturing. It also needs an EU authorised representative, which has its own separate appointee. We can provide professionals in the USA for medical device and IVD manufacturers and help you plan both roles from the start.
United Kingdom
Manufacturers in the UK seeking EU MDR or IVDR certification, with the appointee expected outside the EU.
India
Medical device and IVD manufacturers in India exporting to Europe.
Getting started
Appoint PRRC
Follow these steps to appoint a person responsible for regulatory compliance and keep the decision easy to defend:
- Confirm your roleCheck whether you are a manufacturer, authorised representative, or a party under Article 16, 17 or 22(4).
- Confirm company sizeUse Recommendation 2003/361/EC to decide if an external PRRC is an option.
- Check the candidateCompare qualifications and experience with Article 15, then collect the evidence.
- Document the appointmentRecord duties, authority, deputies and any contract, and split duties in writing if several people are involved.
- Build it into the QMSUpdate procedures, release records and management review inputs.
- Register and maintainEnter the details in EUDAMED, update changes within one week and review the arrangement periodically.
Work with I3CGLOBAL
Appoint a Qualified PRRC With I3CGLOBAL
Tell us about your company and we will suggest the arrangement that fits your size, location and devices.
- Outsourced PRRC for eligible micro and small manufacturers
- Dedicated personnel for placement within your organisation
- Professionals in Europe, the USA, the UK or India
- Qualification evidence for each appointment
Request your proposal
Tell us about your company, your devices and your target markets, and we will suggest the next step.
FAQs
Person Responsible for Regulatory Compliance: Frequently Asked Questions
What is a person responsible for regulatory compliance?
A person responsible for regulatory compliance, or PRRC, is the qualified individual a device manufacturer or EU authorised representative must have under Article 15 of the EU MDR and IVDR. The PRRC makes sure specific duties are met, including conformity checks before release, up-to-date documentation, post-market surveillance and incident reporting.
Who must appoint a PRRC?
Manufacturers and EU authorised representatives must have a PRRC. The requirement also reaches an importer, distributor or other party that takes on manufacturer obligations under Article 16(1), and parties assuming the manufacturer role under Article 17 or Article 22(4) of the MDR.
What qualifications does a PRRC need?
The usual routes are a relevant university degree or recognised equivalent plus one year of regulatory or quality management experience with devices, or four years of that experience without a degree. Manufacturers of custom-made devices may rely on at least two years of experience in a relevant field of manufacture.
Can the PRRC role be outsourced?
Micro and small enterprises and EU authorised representatives may use an external PRRC, provided the person is permanently and continuously at their disposal and a contract records the arrangement. Medium and large manufacturers must have the PRRC within their own organisation.
Does each manufacturing facility need its own PRRC?
Article 15 and MDCG 2019-7 Rev.1 attach the requirement to each legal manufacturer, not expressly to each facility. Several facilities under one legal manufacturer may share one person if the role can be performed properly, and you should document that decision.
Can one organisation provide both my PRRC and my authorised representative PRRC?
The PRRC of a non-EU manufacturer and of its authorised representative cannot be the same person. For a micro or small enterprise, the two also cannot come from the same external organisation.
Is post-market surveillance a PRRC obligation?
The PRRC must make sure post-market surveillance obligations are complied with, under Article 15(3)(c) of the MDR and IVDR. The manufacturer still runs the system. The PRRC does not need to carry out every activity personally.
Does the PRRC report incidents and field safety corrective actions?
The PRRC must make sure the reporting obligations in Articles 87 to 91 of the MDR, or Articles 82 to 86 of the IVDR, are fulfilled. These include serious incidents and field safety corrective actions. Other staff may carry out the reports under the quality management system.
Is a PRRC personally liable?
MDCG 2019-7 Rev.1 does not address personal liability. It says demonstrating conformity remains the responsibility of the manufacturer, while the PRRC stays responsible for the Article 15(3) activities. Liability may depend on national law and contracts, so take legal advice for a specific case.
Must the PRRC be registered in EUDAMED?
Yes. Manufacturers and authorised representatives must provide the name, address and contact details of the PRRC under Article 31 of the MDR or Article 28 of the IVDR. MDCG 2019-7 Rev.1 notes that changes must be updated within one week.
What does I3CGLOBAL provide as a PRRC service?
I3CGLOBAL provides qualified professionals who can be appointed as the PRRC of a medical device or IVD manufacturer. Depending on size, location and requirements, this is an outsourced contractual appointment or qualified personnel placed within the manufacturer’s organisation.
Can a medium or large manufacturer use an outsourced PRRC?
Medium and large manufacturers must have a PRRC within their organisation. I3CGLOBAL can provide qualified personnel for employment within the manufacturer’s organisation, rather than an outsourced consultant.
Where will my PRRC be located?
MDCG 2019-7 Rev.1 assumes a PRRC outside the EU, preferably close to manufacturing, for manufacturers in the USA, the UK or India, and a PRRC within the EU for EU manufacturers. I3CGLOBAL professionals can be located in Europe, the USA, the UK or India.