About
MDR/IVDR Requirement: The Person Responsible for Regulatory Compliance (PRRC)
With the implementation of the EU Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), manufacturers must adapt to new requirements, including the appointment of a Person Responsible for Regulatory Compliance (PRRC).
This role carries specific qualifications and significant responsibilities to ensure organizational compliance.
This course provides a detailed overview of the PRRC role, including:
- Background and rationale behind the MDR requirements.
- Key tasks and responsibilities of the PRRC.
- Approaches for distributing responsibilities when a single person cannot cover all requirements.
- Methods for ensuring oversight of critical processes within the organization.
- Guidance on internal interfaces, preparation, and practical implementation.
Participants will gain practical tips and insights to navigate the challenges of the PRRC role, define responsibilities clearly, and prepare effectively for daily compliance operations under MDR and IVDR.
Programme
The course is delivered in two modules, combining regulatory knowledge, practical guidance, and real-world examples to support PRRC responsibilities.
MODULE 1: Introduction and Legal Requirements
The Regulation on Medical Devices
- Introduction, regulation overview and impact on the industry
- Transition period requirements
- Latest updates and what is next
- Industry experience in MDR preparation
Legal requirements for the PRRC
- Legal framework for the PRRC
- Who needs a PRRC and when?
- Organizational integration and hierarchy
- Qualifications, tasks, and responsibilities
- Options for implementation
Liability Risks for the PRRC
- Fundamentals of civil, criminal, labour and medical device law
- Company liability for damage claims
- Individual liability of the PRRC
- Risk mitigation measures
MODULE 2: Tasks, Oversight, and Interfaces
Tasks of the PRRC – What’s New in the MDR
- Conformity check of products and release
- Technical documentation and EU Declaration of Conformity
- Post-market technical documentation
- Reporting obligations
- Declaration for investigational products
- PRRC oversight and practical challenges – the release matrix
PRRC Interfaces – Examples for processes / SOPs
- Marketing/Sales: Impact of Article 7 on advertisement release
- R&D: PRRC involvement in core teams and early-stage compliance
- Production/Quality: OOS and CAPA processes
- Clinical Evaluation: Limitations to equivalency, special procedures for high-risk devices, SSCP, and PRRC role
- Regulatory Survey & Conformity Assessment: PRRC involvement
- Change Control & Life Cycle Management: Reportable and significant changes (Art. 120), PSUR processes
- Vigilance & Trend Reporting: Art. 88 challenges
The training course is first aimed at qualified and responsible persons in medical devices and pharmaceutical companies and participants who have been aspiring to these tasks.
It is also valuable for all staff having interference with the PRRC to improve their understanding of its role and responsibilities.
Employees of the following department’s profit from our training course:
- Vigilance & Regulatory Affairs
- Quality Assurance & Quality Control
- Management and Legal
Participant experience
Experience with medical device regulatory processes in Europe may be helpful.
This training combines lectures, case study discussions, and interactive Q&A sessions to provide participants with both theoretical knowledge and practical insights.
This blended approach ensures participants leave with actionable knowledge to implement the PRRC role effectively within their organizations.
Lecturers
Arkan Zwick
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director at a private global pharmaceutical and surgical company with products in ophthalmology, orthopedics, and aesthetic dermatology. With over eighteen years of regulatory experience, his responsibilities span advocacy for drug, medical device, combination product, and cosmetic compliance, as well as providing in-house legal support for contract management, mergers and acquisitions, and intellectual property matters. Mr. Zwick ensures regulatory compliance in the EU, collaborates with various notified bodies, and manages global market authorizations in the Americas and Asia-Pacific. He holds a master’s degree in law from the University of Vienna and a PhD in European Law, teaches at the University of Applied Sciences in Vienna, and is a frequent speaker at life cycle conferences and trainings. He is fluent in English, German, and French.
Online Training – 2 modules
MODULE 1 | 21 May 2026 from 09:30 am to 12:30 pm CEST
MODULE 2 | 22 May 2026 from 09:30 am to 12:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 690,00* (until 30 April 2026)
Ordinary: € 885,00*
Freelance – Individual – Academy – Public Administration: € 495,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Register
Ilaria Butta
Events & Training Manager
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.