On 12 October 2018, the MHRA issued Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) providing guidance on the expansion of scope of the medical devices regime to include certain products which had been previously unregulated at EU level.
Article 1(2) of the Medical Devices Regulation (MDR), in force from 25 May 2017, explains that the MDR will regulate “certain groups of products without an intended medical purpose” as though they were medical devices.
There are currently six types of products in this category which are listed at Annex XVI of the MDR.
Annex XVI list
- Contact lenses or other items intended to be introduced into or onto the eye.
- Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
- Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
Note that tattoo and piercing related products are specifically excluded from the Annex XVI product types, and that elsewhere (Article 1(6)(e)) the MDR confirms that products which are subject to the Cosmetic Products Regulation are not regulated as devices.
The EU Commission has the power under Article 1(5) of the MDR to add new groups of products to Annex XVI in order to protect the health and safety of users or other persons or other aspects of public health where this justified because the risks and characteristics of the products are similar to those of a device with an intended medical purpose.
The guidance provides some examples of the types of products intended to be covered by the six Annex XVI product types:
- Non-prescription coloured contact lenses
- Solid body contour modifying implant (e.g. horn implants)
- Dermal fillers
- Body sculpting equipment
- Intense pulsed light (IPL) machines for body hair removal
- Transcranial (non-surgically invasive) stimulation
It explains that manufacturers of Annex XVI products will need to ensure that their products comply with the requirements of the MDR. Among other things this will mean:
- having an authorised representative in the EU, if the manufacturer is outside the EU;
- complying with Common Specifications (CS);
- checking risk classification;
- passing conformity assessment, where required;
- maintaining the technical documentation including a declaration of conformity;
- affixing CE marking to the product;
- assigning each device a unique device identifier (UDI) and submitting this to the UDI database;
- submitting information about the manufacturer/authorised representative or importer to the European Databank on Medical Devices (Eudamed);
- appointing a person responsible for regulatory compliance;
- maintaining a quality management system;
- complying with post-market surveillance and vigilance requirements, such as conducting field safety corrective actions and reporting serious incidents to the competent authority;
- monitoring compliance of others in the supply chain e.g. distributors; and
- maintaining insurance or other adequate financial coverage against potential product liability.
Common Specifications and entry into force
‘Common specifications’ (CS) refers to technical and/or clinical requirements (other than a standard), that provide a means of complying with the legal obligations applicable to a device. They will take into account existing harmonised standards which apply to analogous medical devices.
Annex XVI products do not need to comply with the MDR until the CS for the respective product types have been adopted and published by the Commission, envisaged as being not later than 26 May 2020. Until then, individual Member States’ national qualification of Annex XVI products as medical devices will remain in force, and compliance with applicable national medical device legislation will be necessary.
Even if not yet required to comply with the MDR, Annex XVI manufacturers will need to prepare for compliance.