SIQ: Online seminar: Products Without an Intended Medical Purpose – Regulation (EU) 2017/745, ANNEX XVI
This workshop will be in English and is part of our academy cooperation with the Slowenian notified body SIQ!
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
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.
Costs
- Standard: 295,00 EUR (excl. VAT)
- Get your special 10 % en.co.tec-discount with this code: encosiq10
- incl. seminar documents as PDF and a certificate of participation.
Your Trainer
Uroš Tacar has more than 25 years of experience with medical devices and the field of development and legislation. He participated in the establishment of a quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of head of development and representative of quality management. Among the more important tasks, he managed the production and maintenance of technical files of medical devices. He currently works as an assessor at SIQ and a consultant in the field of medical devices.
Location: ONLINE
The online workshop will take place in a live online e-classroom. 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.
Click here to book now!
Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10
For questions please text: office@encotec.at or call +43 1 8863491
This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!