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Understanding Annex XVI of the EU MDR – How to stay on the market?

Complimentary Webinar

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Understanding Annex XVI of the EU MDR – How to stay on the market?
Understanding Annex XVI of the EU MDR – How to stay on the market?

Date

20 May 2024, 15:00 – 16:00 CEST

Cisco Webex

About

Several products used in aesthetic medicine now fall under MDR. Which ones are they exactly and what does it bring to their manufacturers? Join our complimentary webinar on MDR Annex XVI where we will address regulatory considerations of products without intended medical purpose.

Agenda:

  • What is product without intended medical purpose? (Groups of these products + examples)
  • Requirements on technical documentation
  • Specifics of clinical evaluation
  • Do we need clinical investigation?
  • Transitional periods and upcoming deadlines

Speakers:

  • Lýdie Hojková
  • Aleš Martinovský

Price:

  • Free of charge

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