Introduzione
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.
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.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is Corporate Regulatory Affairs Director at a global pharmaceutical and surgical company active in ophthalmology, orthopedics, and aesthetic dermatology. With over 15 years of regulatory experience, he oversees EU compliance with notified bodies and manages global market authorizations across the Americas and Asia-Pacific. His expertise spans regulatory advocacy for drugs, medical devices, combination products, and cosmetics, as well as legal counsel on contracts, mergers & acquisitions, and intellectual property. Arkan holds a master’s degree in law and a PhD in European Law from the University of Vienna. He lectures in Vienna and speaks regularly at international conferences.
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: € 680,00* (until 30 April 2026)
Ordinary: € 875,00*
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.
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Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.