How to carry out clinical investigations of medical devices in the EU
To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.
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The Medical Devices Regulation (MDR) sets the requirements for medical devices and devices without an intended medical purpose and that can have an aesthetic function. Specifically, Annex XVI of the MDR lists such devices.
Some examples of such devices are contact lenses (including coloured contact lenses), tattoo or hair removal devices, dermal fillers, body sculpting equipment, solid body contour modifying implants
According to the MDR, the common specifications products listed in Annex XVI must address, at least, application of risk management and, where necessary, clinical evaluation regarding the safety of the product.
Aesthetic devices legislation
Medical devices without an intended medical purpose such as certain aesthetic devices follow the classification rules set in the Medical Devices Regulation. Additionally, manufacturers must also consider additional provisions for such devices (Annex XVI devices).
Some classifications examples:
- Contact lenses, including coloured contact lenses, are typically classified as class IIa when used short-term and as class IIb when used long-term.
- Collagen dermal fillers, when manufactured utilising tissues or cells of human or animal origin, or their derivatives, are usually class III devices.
- Solid body contour modifying implants can be class IIb. Indeed, class IIb generally includes all implantable devices and long-term surgically invasive devices with certain exceptions of devices which are class III.
If Annex XVI of the Medical Devices Regulation does not include a certain aesthetic device group, then this device is likely regulated by one of the electronics Directives or by the General Product Safety Directive. For example, the product might be covered by:
- Low Voltage Directive (LVD) if the product is an electronic product generating a voltage between 50 and 1000 V for alternating current, and between 75 and 1500 V for direct current.
- Radio Equipment Directive (RED) if the product is an electronic product using Bluetooth, GPS, Wi-Fi, or other radio waves.
- Electromagnetic Compatibility Directive (EMC) and General Product Safety Directive (GPSD), generally if it is an electronic product not covered by the LVD or RED.
Obelis can help you meet the regulatory requirements to sell your electronic devices in the European Union and United Kingdom, either as LVD, RED, EMC, or GPSD!
Manufacturers of aesthetic devices that fall under Annex XVI of the Medical Devices Regulation (MDR) need to be fully compliant with the Regulation to sell on the European market.
Manufacturers of such aesthetic devices must:
- Identify class and rule of the device
- Be subject to a notified body conformity assessment procedure if their class is not class I
- Draw up the technical documentation and Declaration of Conformity
- Appoint an authorised representative if the manufacturer is not based in the Union
- Assign the necessary codes, such as UDI codes and EMDN codes
- Register in EUDAMED as soon as EUDAMED is fully functional or at the earliest convenience
- Ensure they comply with all requirements of the MDR
- Affix the CE Marking
Obelis, as your Representative in the European Union, Switzerland, and United Kingdom helps you with all points above and more!
Explore our services for Aesthetic Devices. Contact us for inquiries.