Online workshop: Custom-made medical devices – Regulation (EU) 2017/745, ANNEX XIII

Aim

The e-workshop will introduce the participants to the process and provide information on the preparation of the necessary documentation for the proper documentation of a custom-made medical device.

Content

• Brief description of the requirements of the medical regulatory framework
• Classification of the product as a medical device
• Determination of the conformity requirements for a product – demonstration with practical examples:
  • Content of the manufacturer's or its authorised representative's statement.
  • Retention of documentation.
  • Measures to ensure manufacture in accordance with the documentation.
  • Clinical evaluation/prescription and post-market follow-up.

Work method

• The e-workshop will take place in a live virtual classroom. 
• You will receive a link to the online training two days before the event.
• To participate in the online training, you will need a computer with a microphone and a camera and a reliable internet connection. 

Target group

• Process operators involved in the manufacture of custom-made medical devices.
• Representatives of the manufacturers of custom-made medical devices (dental devices, prosthetics, orthotics, etc.).
• Anyone wishing to acquire or improve their knowledge of the assurance or demonstration of conformity of custom-made medical devices. 

Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si