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Annex XVI of new Medical Device Regulation

One of the major changes coming with the new Medical Device Regulaton (2017/745) is the expansion of scope of the medical devices regime to include certain products which had been previously unregulated by EU.

This means that the new Medical Device Regulation will be applied also to “certain groups of products without an intended medical purpose” as though they are medical devices.

We are ready to help you to get compliant with this new regulation, if you are a manufacturer of contact lenses for cosmetic purposes, equipments for lipolysis, liposuction, lipoplasty, laser for esthetics, equipments intended for brain stimulation and all the others as per Annex XVI of new Medical Device Regulation.

Contact us at [email protected]

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