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MDR Annex 16: What You Need to Know

On-Demand Webinar

New regulation for aesthetic products

The new Medical Device Regulation (MDR) introduced the regulation of certain products without an intended medical purpose, listed under Annex XVI. This means that products with non-medical purposes, such as cosmetic lenses, aesthetic implants, and other electronic devices for aesthetic applications, will have important implications.

Manufacturers will have only 6 months to adhere to the requirements that will be described in the Common Specifications (CSs).

In this on-demand webinar, we will highlight our current understanding of the new obligations that aesthetic manufacturers shall fulfill and the necessary steps to achieve regulatory compliance.

Start getting prepared! Time is running out!

Key Topics Covered:

  • General safety and performance requirements
  • Risk Management and Quality Management requisites
  • Main obligations for manufacturers and economic operators

Presented by:

Prof. Melania Battistella, MD

Prof. Melania Battistella, MD

Global Manager Aesthetic Products and Clinical Reviewer at the Clinical Centre of Excellence, TÜV SÜD

Melania is an Aesthetic Doctor that after the degree in Medicine and surgery, attended various specific international training courses in prestigious centers in Brasil, Middle East and Asia.

In 2017, she joined TÜV SÜD as clinical reviewer at the clinical centre of excellence. She is now Global Manager of Aesthetic Product and Professor at the Master of Aesthetic and regenerative medicine of “La Sapienza” in Rome.

She still practicing aesthetic medicine.

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