MDR (EU) 2017/745 – Economic Operators

This seminar aims to provide an in-depth overview of the roles, responsibilities, and regulatory obligations of Economic Operators under MDR (EU) 2017/745.

Date

25 June, 2026

Registration Deadline

18 June, 2026

Format

8-hour courses — Live streaming

Language

Italian

Price

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

MDR (EU) 2017/745 defines the regulatory requirements for Economic Operators, detailing the functions and responsibilities of the Authorized Representative and assembler/sterilizer of systems and procedure kits, as well as introducing the Importer and Distributor in Europe as active participants in the device control process.

This seminar provides an in-depth exploration of their roles, responsibilities, and associated obligations.

Program

  • Economic Operators: definitions

  • Overview: roles of Economic Operators and identity challenges

  • Responsibilities of the Authorized Representative

  • Responsibilities of the Importer

  • Responsibilities of the Distributor

  • Assembler/sterilizer of systems and procedure kits

  • Third parties under Article 16

  • Distribution and OBL: requirements and differences

  • The Quality Technical Agreement (QTA)

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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