Buy the GCP R3 course & get a FREE eBook— your complete ICH-GCP R3 reference guide. Book Now →

  • AI ClinicalAI ClinicalNewRight Arrow
  • Clinical PracticeClinical PracticeRight Arrow
  • PharmacovigilancePharmacovigilanceRight Arrow
  • ManufacturingManufacturingRight Arrow
  • Laboratory PracticeLaboratory PracticeRight Arrow
  • DistributionDistributionRight Arrow
  • Medical DevicesMedical DevicesRight Arrow
  • Regulatory AffairsRegulatory AffairsRight Arrow
  • Research ComplianceResearch ComplianceRight Arrow
  • Health & SafetyHealth & SafetyRight Arrow
  • Quality AssuranceQuality AssuranceRight Arrow
  • BiostatisticsBiostatisticsTrendingRight Arrow
  • Pharmaceutical MedicinePharmaceutical MedicineNewRight Arrow
  • All Bundles
  • Clinical Trials Development
  • GCP & GxP Standards
  • GMP & Quality Assurance
  • Pharmacovigilance
  • Role Based
  • Distribution
  • Medical Devices
  • Medical Writing
  • AI Clinical
  • Quality Assurance
  • Biostatistics
  • Pharmaceutical Medicine
  • Customize your bundleBuild your own path
View all 30 learning paths
  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations Learning Path - courses at £199

About

The Medical Devices – Person Responsible for Regulatory Compliance (PRRC) – EU MDR and IVDR course provides a practical understanding of PRRC responsibilities, qualification requirements, and regulatory obligations under European medical device regulations.
It covers conformity assessment, technical documentation, EU declarations of conformity, post-market surveillance, vigilance reporting, device registration, and quality management system oversight. Learners also explore authorised representative requirements, record retention, risk-based sampling, and inspection readiness through practical scenarios.
Upon completion, learners receive a certification demonstrating their understanding of PRRC compliance requirements.

Who Should Enrol?

  • PRRC and Regulatory Affairs Professionals
  • Medical Device and IVD Manufacturers
  • Quality Assurance and Quality Management Professionals
  • Authorised Representatives and Regulatory Consultants
  • Technical Documentation and Post-Market Surveillance Teams
  • Professionals involved in EU MDR and IVDR compliance, audits, and inspections
📢 Every purchase includes our FREE companion PRRC under EU MDR/IVDR eBook.

What you will learn

Understand the role, responsibilities, qualification requirements, and regulatory obligations of the Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Gain knowledge of PRRC appointment criteria, manufacturer and authorised representative responsibilities, technical documentation, EU declarations of conformity, and quality management system requirements.

Learn key compliance activities including post-market surveillance, vigilance reporting, device registration, record retention, and conformity verification.

Develop expertise in risk-based oversight, change control, conflict-of-interest management, inspection readiness, and regulatory documentation to ensure ongoing compliance throughout the medical device lifecycle.

Course Syllabus

  1. A named person, inside the chain of obligations
  2. Article 15 has six paragraphs, and which paragraph does what
  3. Five duties at Article 15(3)(a) to (e), not six
  4. Three corrections this course exists to make
  5. What a training certificate in this role can and cannot mean
  6. Standing cautions on sources that are guidance rather than law
  7. The fictional Ardenwood Medical Group case study

  1. 1.1 Why the role exists at all
  2. 1.2 Article 15 paragraph by paragraph
  3. 1.3 Who must have a PRRC, and who need not
  4. 1.4 The MDR and the IVDR compared
  5. 1.5 What Article 15 does not require
  6. 1.6 Dates, legacy devices and the horizon

  1. 2.1 The Article 15(1) qualification routes
  2. 2.2 Reading the routes precisely
  3. 2.3 Custom-made devices, and the IVDR
  4. 2.4 Micro, small, medium: the enterprise test
  5. 2.5 Permanently and continuously at their disposal
  6. 2.6 Building the qualification evidence file

  1. 3.1 Ensure, not perform: the shape of the duties
  2. 3.2 Duty (a): conformity checked before release
  3. 3.3 Duty (b): technical documentation and the declaration
  4. 3.4 Duty (c): post-market surveillance
  5. 3.5 Duty (d): vigilance and trend reporting
  6. 3.6 Duty (e): the investigational device statement

  1. 4.1 Where Article 15 attaches to the QMS
  2. 4.2 The PRRC and the management representative
  3. 4.3 Documents, records and change control
  4. 4.4 CAPA, complaints and closing the loop
  5. 4.5 Management review, internal audit and the notified body
  6. 4.6 Approve or audit: a sampling plan that runs

  1. 5.1 The appointment letter
  2. 5.2 The job description and the qualification file
  3. 5.3 Independence, reporting lines and no disadvantage
  4. 5.4 Absence, cover and the deputy that does not exist
  5. 5.5 More than one PRRC, and corporate groups
  6. 5.6 The internal and the outsourced PRRC

  1. 6.1 When an authorised representative is required
  2. 6.2 The Article 11(3) tasks, one at a time
  3. 6.3 Article 15(6) and the representative's PRRC
  4. 6.4 Location, separation and two different people
  5. 6.5 What verification means in practice
  6. 6.6 Changing the representative, and advising the manufacturer

  1. 7.1 The six modules and where the law now stands
  2. 7.2 Actor registration and the single registration number
  3. 7.3 PRRC data in EUDAMED, and who can see it
  4. 7.4 Device registration, UDI and change control
  5. 7.5 Technical documentation, the declaration and retention
  6. 7.6 The records that evidence the role

  1. 8.1 Where liability actually sits
  2. 8.2 Penalties, and what enforcement really exists
  3. 8.3 What notified bodies and authorities examine
  4. 8.4 Recording a disagreement defensibly
  5. 8.5 The failure modes and their controls
  6. 8.6 Great Britain, the horizon, and continuity

  1. The decision points, from appointment to demonstrating oversight
  2. The eight failures that recur, and the control that prevents each
  3. Assigned rather than assumed ownership
  4. A system around the role, not an appointment on paper
  5. Keeping pace with guidance and with EUDAMED module releases
  6. Course completion

  1. 📘 Bonus: PRRC under EU MDR/IVDR eBook (Free with purchase)

Course Benefits

Benefits ebook icon
eBook

Access the course content in eBook format, which can be downloaded and read on your device.

Benefits cpd_points icon
CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

Benefits certification icon
Certification

Receive a personal certificate to show your subject knowledge on course completion.

Benefits affordable icon
Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

Benefits flexible icon
Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

Benefits up_to_date icon
Keep Up to Date

You will stay up to date with a framework whose text is stable but whose surroundings are not: Article 15 of Regulation (EU) 2017/745 and of Regulation (EU) 2017/746, unamended since 2017 and untouched by Regulation (EU) 2023/607 or Regulation (EU) 2024/1860; MDCG 2019-07 Rev.1, the principal interpretive guidance on the role; the EUDAMED roll-out, where Commission Decision (EU) 2025/2371 made actor registration, UDI and device registration, notified bodies and certificates, and market surveillance mandatory from 28 May 2026, while the vigilance and post-market surveillance module and the clinical investigations module remain unreleased; MDCG 2021-25 Rev.1 on legacy devices, which determines when the obligation first bites; Commission Recommendation 2003/361/EC, which decides who may use Article 15(2); and COM(2025) 1023 final of 16 December 2025, a Commission simplification proposal that would remove the qualification requirements and that remains unadopted.

Benefits industry_experts icon
Learn from Industry Experts

The content is written by regulatory affairs and quality practitioners and is built directly on primary sources: Articles 10, 11, 15, 16, 29 to 33, 83 to 92 and 113 of Regulation (EU) 2017/745 with Annexes II, III, IV, VI, IX and XV, the corresponding provisions of Regulation (EU) 2017/746, MDCG 2019-07 Rev.1, MDCG 2021-25 Rev.1, MDCG 2023-3, Commission Recommendation 2003/361/EC, Commission Decision (EU) 2025/2371, ISO 13485:2016, and the Medical Devices Regulations 2002 as amended for the Great Britain contrast. Every requirement taught names its paragraph, every duty is cited to the point of Article 15(3) it comes from, and the course is explicit about which widely repeated statements about the role have no authoritative source behind them at all.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

Learner Rating & Reviews

4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

Recommended Courses

Essentials of EU MDRBest Seller

Essentials of EU MDR

Professional
£493 hrs3 points
IVDR for the Laboratory

IVDR for the Laboratory

Intermediate
£393 hrs3 points
AI - ML Based Software as a Medical Device (EU AI Act, FDA PCCP, GMLP)

AI - ML Based Software as a Medical Device (EU AI Act, FDA PCCP, GMLP)

Intermediate
£393 hrs3 points
US FDA Medical Device Pathways: 510(k), De Novo, PMA and the QMSR Transition

US FDA Medical Device Pathways: 510(k), De Novo, PMA and the QMSR Transition

Intermediate
£393 hrs3 points
Clinical Evaluation Reports and PMCF under EU MDR

Clinical Evaluation Reports and PMCF under EU MDR

Intermediate
£393 hrs3 points