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Obelis has expertise in several industry fields.

From medical devices, electronics, toys to cosmetics, our regulatory experts can assist you to achieve regulatory compliance and market your products in the EU.

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Distance sales devices: a look at EU requirements

Distance sales devices, sold through online platforms, must meet specific regulations outlined in Article 6 of the MDR and IVDR to ensure safety and performance. This includes devices used for remote healthcare services, even if not directly sold within the EU.