🇨🇿 Obligations of custom medical device manufacturers

The event is held in Czech language only!

Unlike in some EU countries, custom manufacturing in the Czech Republic is dominated by micro-enterprises. These are often workshops and laboratories with one or a few employees. At first glance, the obligations imposed on these businesses by the European MDR regulation seem almost impossible to fulfil. Nevertheless, it is possible to comply with them and fulfil the obligations of documentation, quality management system (QMS), labelling, traceability, documentation provided to users (patients), and other obligations in accordance with the requirements of the relevant regulations.

In this webinar, we will explain all the relevant requirements of the MDR and Act No. 375/2022 Sb. in an understandable way. We will use the SÚKL methodological guidelines and other sources and materials that we had the opportunity to contribute to, and during the webinar we will gradually show how to fulfil all obligations in a manner appropriate to the riskiness of the manufactured devices and proportional to the size of the manufacturer's operations. We will also focus on new imaging and 3D printing technologies, as these technologies bring new challenges to the field of custom device manufacturing, and we will explain what needs to be monitored in this area in the future.

Who the webinar is for:

• All manufacturers of custom-made devices

• Custom manufacturers in the field of orthotics and prosthetics, laboratories producing dental prostheses or orthodontic devices, and all others

• Anyone considering manufacturing custom-made devices in the future

• doctors and health insurance company employees

• Anyone working in the field of medical devices who wants to broaden their horizons in this area

Lecturers:

• Aleš Martinovský

• Jakub Musil

Content:

• What are custom-made devices?

• Prescription and its requirements

• Definition of custom-made devices in the context of modern technologies

• Distribution and import

• Requirements for documentation of custom-made devices

• Requirements for the manufacturer's quality management system

• Obligations towards users/patients

• Notification obligations and vigilance

  
  

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 s.r.o.

• ID: 03301931, VAT: CZ03301931

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