MDR (EU) 2017/745 – Clinical Evaluation

In this seminar, the process required to manage clinical evaluation in compliance with the requirements of MDR (EU) 2017/745, MEDDEV 2.7/1 rev. 4, and the relevant MDCG guidelines is described.

Date

23 July, 2026

Registration Deadline

16 July, 2026

Format

8-hour courses — Live streaming

Language

Italian

Price

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

In this seminar, the process required to manage clinical evaluation in compliance with the requirements of MDR (EU) 2017/745, MEDDEV 2.7/1 rev. 4, and the relevant MDCG guidelines is described.

Through the knowledge acquired, it will be possible to identify areas for improvement in the clinical evaluation process and in related processes, such as post-market clinical follow-up (PMCF), risk management, and post-market surveillance (PMS).

Program

  • Clinical evaluation under MDR (EU) 2017/745

  • Supporting documents and guidelines (MEDDEV 2.7/1 rev.4 and MDCG)

  • Demonstration of equivalence with competitor devices

  • Introduction to clinical investigation

  • Post-market surveillance (PMS)

  • Post-market clinical follow-up (PMCF)

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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