Even products that only serve aesthetic purposes, such as colored contact lenses, will be assessed in accordance with the strict MDR regulations. (Credit: kichigin19/AdobeStock)

In late 2022, the EU Medical Device Regulation (MDR) was expanded by the addition of the common specifications (CS) 2022/20346. The spe00cifications describe the aspects that must be examined for devices without an intended medical purpose. These aspects apply in addition to the classical MDR requirements and include certain aspects of risk management. In other words, even products that only serve aesthetic purposes, such as colored contact lenses, will be assessed in accordance with the strict MDR regulations and, in addition, will have to fulfill the requirements laid down in the CS 2022/2346.

Annex XVI to the MDR precisely specifies which devices without an intended medical purpose fall under the scope of the MDR. The foremost consideration for manufacturers at this stage is to know what they need to know or do now. As a notified body, TÜV SÜD also provides certification of conformity with the MDR for devices without an intended medical purpose.

Before the MDR came into effect, many devices and items of electrical equipment without an intended medical purpose had not been subject to the applicable EU-wide criteria. However, the MDR now confronts manufacturers with a comprehensive regulatory act that needs to be first understood, and then complied with.

Products or product groups that now need a certificate of conformity are listed in Annex XVI. They include:

  1. Contact lenses or other items intended to be introduced into or onto the eye, e.g. contact lenses in different colors.
  2. 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, e.g., silicone implants. Excluded from this category are tattooing products and piercings.
  3. Products used for facial or other dermal or mucous membrane filling that are introduced by injection, also referred to as dermal fillers.
  4. Equipment intended to be used to reduce, remove, or destroy adipose tissue, such as equipment for liposuction.
  5. High-intensity electromagnetic radiation emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad-spectrum light, e.g., lasers used for tattoo or hair removal.
  6. Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.

The backdrop to this change in perspective is the fact that many products without an intended medical purpose are similar to the devices with an intended medical purpose falling under the scope of the MDR, both in their functions and in terms of potential complications and side effects. This was reason enough to expand consumer protection to cover these devices.

Given the rapidly growing market for aesthetic surgeries and aesthetic applications in general, the expanded scope of the MDR means that many manufacturers now have to address the strict provisions of the regulation for the first time.

Common Specifications

The common specifications govern the safety regulations and risk management applicable to devices without an intended medical purpose as listed in Annex XVI. In view of the diversity of products in this category, the EU only released the requirements in late 2022 after a long process of discussions. In accordance with these requirements, manufacturers must proactively address and arrange for the assessment and certification of conformity of their devices. As their first step, they should always contact a Notified Body. As the common specifications also apply to existing products, all manufacturers of products listed in Annex XVI must prove that their devices are in conformity with the MDR.

What To Do

In the run up to the assessment, companies first need to fulfill some internal requirements, such as: There must be both technical documentation and, for example, for Class III devices, a clinical evaluation for every device. The business as a whole must have an appropriate quality management system.

Within the scope of postmarket surveillance, manufacturers must accompany and continuously monitor their devices on the market. And manufacturers must also have appropriate insurance cover in the interest of consumer protection. The implementation of these preparations alone takes a lot of time, particularly for companies that have no previous experience of these requirements.

The extended approval process of the common specifications is already leading to long waiting times in the processing of applications for conformity certification. Although manufacturers have certain transition periods until they need to present the certificates, they should take action immediately. The length of the individual deadlines depends on various factors, including prior certification in accordance with the Medical Device Directive (MDD) or fundamental changes in the product.

Dual-Use Devices

Special attention should be given to products that can be used both with and without an intended medical purpose. A good example are silicone implants. They are used, for example, after a mastectomy — surgery performed to remove a breast, most often used to treat breast cancer — and thus for a very clear medical purpose. However, if an identical implant is used for breast modification for purely aesthetic reasons, the implant is considered a product without an intended medical purpose and is thus subject to additional provisions.

With respect to certification and the required documentation, manufacturers may thus have to treat the same item as two different products. While this may appear a baffling bureaucratic obstacle at first glance, it is actually an important element of consumer protection for products with a nonmedical purpose. The MDR very clearly specifies which documents are necessary for presenting the safety and performance requirements of devices with an intended medical purpose. However, if these products are also used for aesthetic purposes, manufacturers must provide additional documents that fulfill that requirement, such as documents that furnish evidence of the manufacturer’s risk management. If medicinal products are incorporated in a device, they too require additional assessment by a notified body.

Conclusion

Neither the MDR nor Annex XVI are new. Nevertheless, the entry into force of the common specifications now presents a new situation for manufacturers of devices without an intended medical purpose. OEMs must prove that their products are in conformity with the MDR and the common specifications.

TÜV SÜD has prepared for the anticipated surge in demand and has provided time slots and other resources. Nevertheless, waiting times will be unavoidable, primarily due to the repeated delays in approval of the common specifications. Manufacturers should also make use of the many sources of information, including question and answer documents, official websites, checklists and best practice guidelines, in order to prepare for conformity assessment as thoroughly as possible. 1

Reference

  1. "Q&A on Transitional Provisions for Products Without an Intended Medical Purpose Covered by Annex XVI of the MDR," European Commission, September 2023.

This article was written by Christian Götz, Head of Department Non-Active Medical Devices, and Dr. Jara Brenke, Product Specialist Non-Active Medical Devices, TÜV SÜD Product Service GmbH, Munich, Germany. For more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it. or visit here .