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Online seminar: Products Without an Intended Medical Purpose – Regulation (EU) 2017/745, ANNEX XVI

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What are products without an intended medical purpose?

  • Contact lenses or other items intended to be introduced into or onto the eye.
  • Products intended to be totally or partially introduced into the human body for the purpose of modifying the anatomy or fixation of body parts.
  • Substances intended to be used for facial or other dermal or mucous membrane filling and equipment intended to be used to reduce or remove adipose tissue.
  • High intensity electromagnetic radiation emitting equipment for use on the human body and transcranial brain simulation equipment.

Annex XVI to Regulation (EU) 2017/745 includes a list of categories of devices without an intended medical purpose. These are devices based on similar technology as medical devices and used in a similar way but with a non-medical purpose. As the named product groups present certain risks when in use, they are expected to be controlled in accordance with the Regulation and, where necessary, to be subject to a clinical safety assessment.

Aim

The e-training will introduce the participants to the procedure and provide information on how to prepare the necessary documentation to properly document a device without an intended medical purpose.

Content

  • Brief description of medical regulatory requirements
  • Products without an intended medical purpose to which Regulation (EU) 2017/745 applies
  • Determination of conformity requirements for a product – presentation with practical examples:
    •   The manufacturer's or authorised representative's declaration
    •   Measures to ensure manufacture in accordance with the documentation
    •   Preparation of the documentation – risk management and clinical evaluation/prescription and post-market monitoring of the product

Work method

  • The e-training 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 and the representatives of manufacturers of devices without an intended medical purpose.
  • Anyone wishing to acquire or upgrade their knowledge of ensuring or demonstrating the conformity of devices listed in the group of products without an intended medical purpose.

Course and materials will be in English language.

Lecturer

Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous wor with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards.

The online seminar will take place in a live online e-classroom and will be divided into three parts with breaks in between.  Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

Certification procedure

Main steps in the process of obtaining the CE mark and more about certification procedure according to Regulation (EU) 2017/745 and ISO 13485 you can find HERE.

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

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