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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 April – 20 October, 2026

Registration Deadline

19 February, 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: 19 February, 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)

For more information or to enroll, continue on the University of Ferrara website