Training and Advanced Course for the Person Responsible for Regulatory Compliance (PRRC)
The Person Responsible for Regulatory Compliance (PRRC) Course is the result of a collaboration between the University of Ferrara and Complife Group. It trains qualified professionals in accordance with EU Regulations 2017/745 (MDR) and 2017/746 (IVDR), equipping them to manage the technical and regulatory responsibilities required of medical device and in vitro diagnostic manufacturers.
Date
20 Apr–20 Oct, 2026
Registration Deadline
25 March, 2026
Typology
Hybrid, 66% Online + in-person classes at the University of Ferrara
Language
Italian
Pricing
2,500€
Give Value to Your Experience with a Recognized Qualification
Course Description
The Person Responsible for Regulatory Compliance (PRRC) Course is the result of a collaboration between the University of Ferrara and Complife Group.
It trains qualified professionals in accordance with Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), capable of managing the technical and regulatory responsibilities required of manufacturers of medical devices and in vitro diagnostic devices.
Learning Objectives
- Understand the requirements and duties of the PRRC under the MDR and IVDR
- Acquire advanced technical and regulatory competencies
- Manage certification and post-market surveillance processes
- Interact with Notified Bodies and Competent Authorities
- Operate autonomously and responsibly in regulatory compliance
Course Program
Module 1: Introduction to MDR / IVDR Regulations
Module 2: Role and Responsibilities of the PRRC
Module 3: Manufacturer’s Management System and Organization
Module 4: Product Documentation
Module 5: Surveillance, Vigilance, and Reporting Obligations
Module 6: Legal Responsibilities and Contracts
Key Information
Duration: 225 total hours –9 ECTS
Format: Blended learning (≈ 66% online + in-person classes at the University of Ferrara)
Application Deadline: 25 March, 2026
Course Period: 20 April – 14 September 2026
Final Exam: 1 – 20 October 2026
Attendance Requirement: Mandatory
Location: Department of Life Sciences and Biotechnology – Via Luigi Borsari 46, Ferrara
Admission Requirements and Qualification
Final Certificate Issued by the University of Ferrara:
- Training Certificate for high school graduates
- Advanced Certificate for university graduates,
Bachelor’s or Master’s degree
Target Audience
The course is intended for:
- Professionals and consultants in the medical device or in vitro diagnostics sector
- Company roles in Quality, Regulatory Affairs, R&D, or Manufacturing
- Recent graduates and diploma holders seeking specialization in regulatory compliance
Registration Fee
€ 2,500
Payment in two installments:
- € 1,500 upon enrollment
- € 1.000 by 30 April 2026
(exempt from VAT, pursuant to DPR 633/72 art. 1 and 4)
Contacts
Academic Information: formazione@complifegroup.com
Administrative Information: https://ums.unife.it/informazioni-e-contatti/ums.unife.it/informazioni-e-contatti
