Objectives: During this presentation, an overview is given of the strict requirements for certain groups of devices with an aesthetic purpose, that follow from new EU Regulation. What is the impact of this Regulation? With the adoption of the Medical Device Regulation, (EU) 2017/745 (“MDR”) , certain groups of aesthetic devices (“Annex XVI devices”), will be stricter regulated in Europe. Devices such as (breast) implants, and skin treatment devices, will be regulated similar to medical devices, using a similar technique.
Introduction: With the adoption of the Medical Device Regulation, (EU) 2017/745 (“MDR”) , certain groups of aesthetic devices (“Annex XVI devices”), will be stricter regulated in Europe. Devices such as (breast) implants, and skin treatment devices, will be regulated similar to medical devices, using a similar technique. Annex XVI devices need to comply with the MDR before they can be sold in the EU, as of May 2020. What is the impact of the MDR, on the availability of devices in the EU?
Materials / method: What can clinicians expect and how can manufacturers of, for example, IPL devices, implants, facial or other dermal or mucous membrane fillers, equipment for liposuction, keep market entrance after May 2020?
The Cosmetic industry and Medical Devices industry has grey areas, areas where there is an overlap of EU legislation. Manufacturers often face regulatory issues, determining which EU Directive or Regulation applies.
Results: With the adoption of the MDR, for certain devices it will be clearer by which Regulation to apply. This because Annex XVI of the MDR addresses 6 groups of aesthetic devices: 'products without an intended medical purpose'.
Attendees will get an high level overview of the Regulatory requirements to apply with to be able to keep marketing their devices within the EU, including the steps they can take to be MDR compliant.
Conclusion: Many devices that have aesthetic purposes are affected by the MDR and need to apply with strict regulations in order to stay on the market after May 2020. The stricter Regulations have a huge impact on the availability of such devices within the EU. Prepare now and be ready to keep your position within the market, or even expand it!
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