🇨🇿 Aesthetic medicine and MDR – what you need to know in 2025

The event is held in Czech language only!

Our online seminar will address the issue of "medical devices" used by healthcare providers in the field of aesthetic medicine from two different perspectives. First, we will explain the obligations arising from EU Regulation 2017/745 (MDR) that apply to devices without a therapeutic purpose, i.e., devices listed in Annex XVI. We will explain the legal status of these devices on the market, which devices may continue to be placed on the market, distributed, put into service, and used. We will explain how to identify devices that no longer meet the requirements of the MDR. Examples will be used to explain what this current situation means for healthcare providers, distributors, and manufacturers of such devices. We will also explain the issue of so-called common specifications, which is particularly important for manufacturers and anyone who would like to become a manufacturer of devices without a therapeutic purpose in the future. We will also discuss the options currently available to individuals – from manufacturers to doctors – to deal with the current situation. In the second part of the seminar, we will focus on the general obligations of healthcare providers when using all types of medical devices, arising in particular from Act 375/2022 Coll. and the current inspection practice of the State Institute for Drug Control (SÚKL).

Who the webinar is for:

• healthcare providers in the field of aesthetic medicine

• doctors and persons using devices regulated by the MDR

• persons responsible for purchasing for healthcare providers

• manufacturers of devices without therapeutic purpose and anyone planning to manufacture or have manufactured this type of product and market it under their own name

• distributors and importers of devices without therapeutic purpose

• quality department staff and regulatory specialists of manufacturers

• quality department staff at healthcare providers

• regulatory specialists of distributors and importers

• anyone interested in the legal framework and practical aspects of providing services in the field of aesthetic medicine

Lecturers:

• Aleš Martinovský

• Magdalena Folkmanová

Content:

• What are medical devices without therapeutic purpose (MDR, Annex XVI) and how do they differ from traditional medical devices and accessories?

• How to identify which medical devices without therapeutic purpose will be legally available on the market in 2025 and which will not.

• Explanation of the so-called transitional provisions of the MDR.

• Obligations of healthcare providers when using non-medical devices under European and Czech legislation.

• What is currently relevant for non-medical devices in terms of import and distribution.

• Obligations of manufacturers of non-medical devices.

• How difficult it is to place new non-medical devices on the market ("certify" them).

• General obligations of healthcare providers when handling medical devices and the most common mistakes and shortcomings.

Additional information:

• during the webinar, participants will have the opportunity to ask questions

• each participant will receive a certificate of participation

• a PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica

• ID: 03301931, VAT: CZ03301931

• registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město