EU Medical Device Regulation and its implications for cosmetic devices

The EU’s MDR means big changes for devices with non-medical purposes. The clock is already ticking, don’t miss out on the opportunity.

EU Regulation 2017/745, created with the key aim of protecting public health, has many important implications for products with non-medical purposes. This list of products includes cosmetic lenses, aesthetic implants, subcutaneous fillers, lifting threads, liposuction and lipolysis equipment, lasers and other electronic devices for aesthetic applications.

By May 2020 every device will need to comply with the MDR including the CE Marking procedure. All must conform to the same strict safety standards applied to similar medical devices. Our free webinar is here to help manufacturers prepare.

Manufacturers must start to consider their obligations under MDR at the earliest opportunity. This will include holding comprehensive technical documentation supported by tests and clinical data for ensuring stringent safety standards. They will also need to establish Quality Management and Risk Management Systems, while being constantly aware of market feedback.

Key topics covered:

• Legal landscape and timelines
• Manufacturers’ responsibilities and to-do’s lists
• General safety and performance requirements (including applicable technical standards)
• Classification and conformity assessment procedures
• Quality Management (ISO 13485) and Risk Management (ISO 14971)
• Post market vigilance and surveillance system

ABOUT THE SPEAKERS

Dr. Melania Battistella
doctor, MD – Cosmetics Clinical Reviewer at Clinical Centre of Excellence, TÜV SÜD

Melania Battistella, MD, is Cosmetics Clinical Reviewer at Clinical Centre of Excellence, TÜV SÜD Group. After receiving her degree in Medicine and Surgery, she pursued extensive further training at prestigious centres in Brazil, Asia and the Middle East.

Since 2013 she has contributed her expertise as a freelance advisor in the R&D departments of various aesthetic medical companies, assisting with product and protocol development and education of distributors and end users of class II b and class III aesthetic medical devices. In 2017, Melania joined TÜV SÜD as clinical reviewer at the Clinical Centre of Excellence.

Attilio Durantini
Project Manager – Cosmetics, TÜV SÜD

Attilio Durantini is Project Manager, Cosmetics, TÜV Italia. He began his work with TÜV SÜD product services in 1992, looking after products falling under the requirements of European Directives.

Between 1996 and 2014 he served as Business Unit Manager of Medical Health Services at TÜV Italia, and from 2015 to 2017 worked in Food Safety as Managing Director of Lab pH.

Today, he is back at Medical Health Services managing cosmetic products.

Related Services: Medical Device Regulation (MDR) | EU In Vitro Diagnostic Medical Device Regulation (IVDR) | Medical Device Single Audit Program (MDSAP)