Medical devices cover a wide range of products, from more common ones such as sticking plasters, glasses and wheelchairs to more high-tech equipment such as implantable devices, X-ray machines, MRI scanners and artificial limbs.
In the EU, medical devices must have a valid CE marking before they can be placed on the market. Products classified higher than class I are evaluated by notified bodies under the supervision of national competent authorities in each Member State. The notified body issues a certificate if the product meets the CE marking requirements. The certificate becomes part of the manufacturer's documentation for the product's safety and CE mark. The European Medicines Agency (EMA) or a national competent authority for medicinal products is consulted on certain medical devices that contain medicinal substances or can evaluate certain medical devices that are combined with a medicinal product.
The new EU regulation on medical devices that becomes applicable in spring 2020 contains specific requirements on devices incorporating or consisting of nanomaterials.
Under this regulation, special attention shall be given to nanomaterials in the design and manufacture of medical devices. It specifies the requirement of reducing, as far as possible, any risks linked to the size and the properties of nanoparticles which are or can be released into the user's body.
Devices incorporating or consisting of nanomaterials fall under the highest risk class, class III, if they present a high or medium potential for internal exposure, and should be subject to stricter evaluation procedures.
- European Commission: New regulations on medical devices
- Regulation on Medical Devices (EU) 2017/745
- Scientific opinions concerning medical devices: SCENIHR Final Opinion on ‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’
- European Trade Association for Medical Technology Industries (MedTech Europe)