Sep 11, 2019

The scope of the European Medical Devices Regulation (MDR) covers not only medical devices but also cosmetic and aesthetic products. Affected manufacturers will have to meet CE Mark certification requirements and maintain certification starting in May 2020.

According to Annex XVI of the MDR, products such as contact lenses and collagen implants will be considered medical devices under the new Regulation. Cosmetic and aesthetic product manufacturers that have no medical devices in their portfolios may find MDR compliance challenging, as these products were not required by the Medical Devices Directive (MDD) to obtain CE Marking for sale in Europe.

Which cosmetic products fall under MDR requirements?

Annex XVI of the MDR redefines the following cosmetic products as medical devices:

  • Colored contact lenses
  • Liposuction equipment
  • Collagen implants
  • Tattoo removal equipment
  • Dermal fillers
  • Laser or Intense Pulsed Light (IPL) hair removal equipment
  • Skin resurfacing equipment

What MDR compliance means for cosmetic product manufacturers

In order to establish and maintain MDR compliance starting in 2020, cosmetic and aesthetic manufacturing companies will need to establish processes including determining how their products will be classified under the Regulation; partnering with a designated Notified Body to undergo CE Mark certification; and implementing a quality management system according to the EN ISO 13485:2016 standard.

Furthermore, companies with no physical presence in the EU will need to appoint a European Authorized Representative for in-country representation. Plans must also be in place to address risk management and post-market surveillance requirements, clinical evaluation reporting and related MDR-mandated processes.

Before the May 2020 deadline, cosmetic and aesthetic product companies will need to identify any deficiencies in their operations regarding MDR compliance and consider third-party gap analysis and compliance support if necessary.

Learn more about European MDR requirements for medical devices and cosmetic products: