The fast approach of 26 May 2020, the date of application for the Medical Device Regulation, has the medical devices industry holding its breath. Manufacturers of conventional medical devices are already taking advantage of the transitional period since the MDR took effect to ensure that their companies, processes and products are MDR-compliant so as to avoid the threat of a marketing/sales freeze for non-conforming products.
But the MDR does not apply just for “conventional” medical devices. Article 1(2) of the MDR, in conjunction with Annex XVI of the MDR, expressly includes product groups WITHOUT an intended medical purpose. As a result, the MDR will apply even to manufacturers, importers and users of products which had previously been unregulated by medical devices law.
In particular, the general safety and performance requirements for “conventional” medical devices also apply for products in accordance with Annex XVI. This means that, when used for the purpose intended, the product must pose a risk that is no more than the maximum acceptable risk, or no risk at all, consistent with a high level of protection for the health and safety of users.
The requirement for demonstrating a clinical benefit will also apply for the products without an intended medical purpose mentioned in Annex XIV, just as they do for “conventional” medical devices. The clinical evaluations for these products must be performed based on relevant data concerning safety, including data from post-market surveillance, post-market clinical follow-up (PMCF) and, where applicable, specific clinical investigations. The performance of clinical investigations for the product groups specified in Annex XVI may only be dispensed with if reliance on existing clinical data from an analogous medical device is duly justified.
Annex XVI of the MDR contains a list of product groups without an intended medical purpose for which the provisions of the MDR will apply in mandatory fashion as of 26 May 2020. The following product groups will be affected:
- “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.”
(Annex XVI, EU-Regulation 2017/745)
Additions to this list cannot be ruled out: the Commission is authorized to adopt delegated acts in order to add more product groups to the list in Annex XVI. It can do so when justified on account of the similarity between a device with an intended medical purpose which has been placed on the market and a product without a medical purpose in respect of their characteristics and risks.
Manufacturers, importers and distributors of the products mentioned in Annex XVI of the MDR should therefore be aware that their companies and products will be subject to the provisions of the MDR: the duties of economic operators in terms of the MDR will apply to them as well. A product’s failure to conform to the provisions of medical devices law may ultimately result in a marketing or sales freeze and failure to comply with the MDR may result in civil liability as well as product liability.back