🇨🇿 In-house medical devices and IVDs: current situation and the future

The event is held in Czech language only!

This online seminar is primarily intended for regulatory specialists and quality managers of providers.

Does your clinic or department manufacture medical devices from purchased materials, parts, or other medical devices? Does your laboratory produce its own diagnostic tests or use commercially available tests in a manner other than that specified in the instructions for use, or do you perhaps use RUO materials?

This webinar will guide you through the maze of Article 5(5) of the IVDR regulation and the equivalent provision (with different content) of the MDR regulation. Article 5(5) defines specific exemptions and obligations for medical devices manufactured and used exclusively within a healthcare facility and is notorious among all healthcare providers as a complication brought about by the MDR for healthcare operations and, in particular, by the IVDR for laboratories. During the seminar, we will focus on the practical approach to obligations – from correct classification according to the new rules to the effective use of the SÚKL methodological recommendations. The key added value of the course is a glimpse into the near future: we will analyze the planned revisions of both regulations, which aim to modify the rules for in-house devices once again. The proposals bring certain simplifications, however, many obligations remain. Our goal is not just to cite paragraphs, but to show you how to meet the requirements of supervisory authorities without unnecessarily disrupting your regular operations and without limiting patient care. 

Who the webinar is for:

• Clinical laboratory managers

• Medical technology department staff at hospitals

• Quality managers and regulatory specialists at healthcare providers

• Specialists responsible for laboratory accreditation

• Research and development staff at healthcare providers, or those involved in designing new methods and procedures

• Anyone working in the field of medical device and IVD regulation who wants to broaden their horizons on the issue of in-house devices

• Managers of healthcare providers responsible for compliance with applicable legislation

• Anyone working at the intersection of manufacturing and healthcare services

Lecturers:

• Ing. Jakub Musil

• Ing. Aleš Martinovský

Content:

• Definition and distinction of in-house medical devices and IVDs

• Obligations of healthcare facilities under Article 5(5) of the MDR and IVDR

• Practical fulfillment of laboratory obligations under the IVDR using the methodological recommendations of the State Institute for Drug Control

• Practical fulfillment of the obligations of healthcare facilities under the MDR

• Basic principles and classification process under the IVDR, implementation and classification rules under Annex VIII of the IVDR

• Proposed amendments to Article 5(5) in the upcoming revision of the MDR

• Proposed amendments to Article 5(5) in the upcoming revision of the IVDR

  
  

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