Elf ears or devil horns, elements implanted under the skin, stretched earlobes and decorative scars on the skin. The world of body modification encompasses many different forms from branding to splitting the tongue.
Very few manufacturers and artists are aware that some of these products fall under the new Medical Device Regulation EU 2017/745 (MDR). For this reason, in this article we will take a closer look at these products, the gray areas and the challenges that the European market brings with it for players in this segment.
What we are talking about:
The only differences between some of the products used for body-modification and some medical devices is the intended use. While medical devices have a clear medical intended use which defines them as medical devices according to the MDR, similar products without this medical purpose are used for body art. The European Commission recognized this and followed the intend of the rules in Europe to implement harmonized product standards to support safe products, included some of the products used for body modification in the scope of the new Medical Device Regulation (MDR).
The MDR states that:
Therefore, tattooing products and piercings are excluded.
In contrast to classic piercing products, which can be removed without major problems (even if this can sometimes be difficult due to the design of the product), products that fall within the scope of the regulation usually must be removed through a medical/ surgical procedure. A navel piercing, for example, which can be easily removed by the user itself, will not be a product in the sense of Annex XVI.
So-called transdermals, i.e., transdermal implants, which are often used to attach various pieces of jewelry, must be removed as part of an invasive procedure. If it is not possible to remove the body jewelry "bloodlessly", it will usually be a product to which the MDR applies. If it cannot be removed at all, that is of course also true.
Which obligations are coming with that for the manufacturer of such products?
As a manufacturer one must comply with all the obligations laid down in the MDR. Starting with the Quality Management System (QMS), Risk Management and clinical evaluation as well as a system for post market surveillance (PMS) and active gathering of “clinical” data from the market.
They must be registered as economic operators and register their devices. A Basis-UDI-DI and the respective Unique Device Identification (UDI) Codes must be assigned to the devices. In case of implantable devices, an implant card must be provided, and the devices must be delivered with an instruction for use containing the applicable information according to Annex I of the MDR.
An involvement of a notified body for the conformity assessment of these devices will be mandatory for the most manufacturers. They must apply for the respective procedure and go through audits of their QMS and review of the technical documentation of the devices. Manufacturers must assign a “person responsible for regulatory compliance” (PRRC) which has the respective qualification as outlined in the MDR. If the manufacturer has his place of business outside the European Union, he must assign an authorized representative within the European Union which has to fulfill the respective obligations as specified in article 11 of the MDR.
According to Article 1, the products specified in more detail in Annex XVI fall within the scope of the MDR from the start of application of the Common Specifications (CS) issued for them. These apply 6 months after they come into force. These specifications were originally planned to be issued by May 26, 2021, but this did not occur. At present, no one can predict when they will be enacted either.
However, the transition period is only 6 months. The first experiences with manufacturer of medical devices show that a transition period of 4 years was too short for many of these manufacturers. And the requirements for manufacturers of such body modification products are the same as for manufacturers of devices with risk class IIb and III, so called “high-risk devices”.
For users of these products, i.e., the artists who bring these products in or on the body, this means that in Europe they are only allowed to use products that have a CE mark. The same classification rules apply to these products as to medical devices. This means that due to the nature of the products, they are usually assigned to a risk class that makes it mandatory for a notified body to be involved in the conformity assessment procedure before the product can be CE marked. It is imperative that users ensure that they have the necessary specialist knowledge to recognize products that have been incorrectly CE marked. In addition, reporting obligations that are specified by the German Medizinprodukterecht-Durchführungsgesetz (MPDG) may apply to these users in Germany.
Many of the products in the body modification segment are imported from so-called third countries. So, they are made in Asia, for example, and shipped to Europe. Anyone who purchases such products directly from a third country and puts them on the market here (regardless of whether they are resold or used themselves) is an importer and must meet the relevant obligations according to article 13 and 14 of the MDR, including registration and testing obligations.
Your products fall under the MDR and you need someone to translate the requirements from the dry and incomprehensible regulation text? Feel free to contact us. Our experts will help you to interpret the obligations and tasks clearly.