MDR (EU) 2017/745 – Medical Device Regulation

The seminar provides a clear overview of MDR (EU) 2017/745 requirements and key changes needed to achieve CE marking.

Date

28 May, 2026

Registration Deadline

21 May, 2026

Format

8-hour courses — Live streaming

Language

Italian

Price

€580 for non-clients
€435 for clients — VAT excluded

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The seminar enables participants to gain a thorough understanding of the purpose and requirements of MDR (EU) 2017/745, to identify the additional or divergent aspects compared to MDD 93/42/EEC, as amended, and to interpret the new obligations in order to demonstrate compliance with the Regulation and affix the CE marking.

Knowledge of MDR (EU) 2017/745 is essential for all manufacturers intending to place medical devices on the European market.

Program

Current status and history of European Regulations
Content of Regulation (EU) 2017/745 on medical devices: requirements and updates
What changes for Manufacturers
How the role of Notified Bodies changes
The Person Responsible for Regulatory Compliance (PRRC)
Quality Management System according to the European Regulation
Technical Documentation: alignment with requirements
UDI Code: how to implement and manage it effectively
Clinical evaluation process: key elements
Timing and strategies: effectively managing the transition period

The seminar includes

MDR Toolkit (experience, templates and tools)
Educational tutor support
Training materials
Skills assessment test
Certificate of attendance

Seminars are available for individual purchase, but they are also included in our Advanced Master and MDR Course training programmes, which offer more comprehensive learning paths and greater overall cost advantages.

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