Adopted in 2017, the EU Medical Device Regulation (MDR) brought a host of changes. In its Annex XVI, for example, the regulation expands its scope to take in new product groups referred to as “products without an intended medical purpose”—in other words, items or devices used for aesthetic indications, such as colored contact lenses or equipment for laser skin treatments. “Dual use products” (i.e. products both with and without an intended medical purpose), such as liposuction devices or body-forming silicone implants, also fall under the scope of Annex XVI. Breast implants, which are used both in breast reconstruction after breast cancer surgery as well as in cosmetic surgery, are one example of this product category.
New Obligations Take Manufacturers by Surprise
The EU MDR requires these products to be tested in accordance with MDR provisions. In the past, the application of these products to or in the body sometimes caused medical complications, some of them severe. The reason is that many of these products without an intended medical purpose are very similar to their medical-device counterparts in their function, risk profile and application. Adverse reactions to the use of products without an intended medical purpose may go as far as necrosis, eye inflammation or even blinding. Given this, the EU Commission took action and expanded the scope of the MDR to enhance consumer protection. However, this step has taken many manufacturers by surprise.
As demand for aesthetic treatments continues to rise, the number of products distributed and used in this market is increasing in step. If the device is listed in Annex XVI, manufacturers now have to comply with the same general safety and performance requirements (GSPR) as regular medical devices.
Annex XVI: List of Groups of Products Without an Intended Medical Purpose
- 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.
Getting Ready for the Certificate of Conformity
Manufacturers should be aware that they need to involve a Notified Body that is authorized to assess and confirm MDR conformity. However, before the start of conformity assessment, manufacturers first need to do their homework. This can pose quite a challenge for manufacturers that have no prior experience with the regulatory requirements of the MDR. For example, they need to create a Technical Documentation (TD) for the product, perform clinical evaluations and maintain an in-house quality management system.
Even after the product has been placed on the market, manufacturers still need to fulfil certain requirements, such as post market surveillance, which requires products launched on the market to be continuously monitored and assessed to ensure consumer safety. Furthermore, manufacturers need liability insurance coverage. Establishing these in-house processes and taking these actions is imperative. Manufacturers that fail to prepare in advance will experience delays during which their products will not generate revenue.
Apart from the requirements included in the MDR, products without an intended medical purpose also need to comply with the “common specifications,” which primarily focus on risk management and safety information. The conditions and requirements for the approval of the products listed in Annex XVI are described in seven Annexes. Since the common specifications apply to a host of different products with a wide variety of applications, their release took the EU longer than expected and finally occurred in December 2022.
Early Information and Action
To make matters worse, the common specifications entered into force a mere 20 days after their publication, heaping further pressure on companies that already have some catching up to do where regular MDR requirements are concerned. In addition, the specific requirements apply to both existing and new products. And where dual use products are concerned, manufacturers not only need the regular approval in accordance with MDR requirements, but also an approval confirming compliance with the common specifications. In the case of products listed in Annex XVI that include a medicinal product, the procedure is even more complex. Here, manufacturers require assessment by a competent body for the approval of their product, which may result in a longer waiting period until final certification.
The EU Commission grants manufacturers certain periods for transitioning to the new requirements. The lengths of these periods depend on a host of different factors. However, the above delays have already caused long waiting lines at the Notified Bodies. Therefore, manufacturers should prepare for the certification of products listed in Annex XVI as soon as possible.