Annex XVI of the MDR lists products covered by this regulation but which do not have an “intended medical purpose,” such as those with a purely aesthetic purpose. These products must undergo a specific clinical evaluation.
The clinical evaluation of products without an intended medical purpose, mentioned in Article 1(2) and listed in Annex XVI of Regulation (EU) 2017/745 (MDR), presents a specific challenge. According to Article 61(9) of the MDR, the obligation to demonstrate a clinical benefit is replaced, for these products, by the need to demonstrate their performance.
This changes the priority of demonstrating compliance with general safety and performance requirements, shifting from the traditional benefit/risk assessment to an evaluation focused on the clinical performance of the device and risk management.
Clinical Evaluation Without Clinical Benefits
In the traditional clinical evaluation of medical devices, clinical benefits play an essential role. Defined as a positive impact on individuals’ health, patient management, or public health, they must be measurable and are considered to evaluate the benefit/risk ratio–to determine whether minimized risks and adverse side effects are acceptable compared to measured benefits.
For products listed in Annex XVI, the MDR stipulates that no clinical benefit can be claimed. This absence of clinical benefit complicates the assessment of the acceptability of risks associated with the use of these products. Therefore, the clinical evaluation must rely on:
- Performance: Demonstrating that the device meets clinical performance criteria defined by the manufacturer.
- Risk management: Demonstrating that risks have been eliminated or reduced as much as possible while preserving the product’s main function.
The necessary data for clinical evaluation can be collected from clinical investigations, publications, preclinical data, or post-market data. It is recommended that the manufacturer prepares two separate clinical evaluation reports for devices with both medical and non-medical purposes: one for each purpose.
Risk Management Process
The risk management process to be implemented for products without an intended medical purpose is detailed in the Common Specifications (CS) of Regulation (EU) 2022/23461, which complement ISO 14971 and introduce the following specificities:
- Global residual risk: It must be assessed without considering clinical benefits.
- User and consumer groups: Risks must be analyzed based on user categories (health professionals or laypersons) and consumers, with identification of groups to exclude from use.
- Acceptability of residual risks: If adverse side effects are temporary and do not require medical or surgical intervention, permanent impairment of an anatomical function or permanent alteration of an anatomical structure, residual risks may be considered acceptable. Otherwise, the manufacturer must justify the acceptability of these risks.
- Device performance: Risk control measures can be taken at the expense of the device’s performance, as long as the product’s main function is maintained.
- Safety information: It must appear on the instructions and labeling but also be easily accessible to users by other means (public).
Additionally, the CS reminds that clinical data and incidents from production and post-production must be considered in risk analysis. For certain products in groups listed in Annex XVI (see Table 1), the CS defines specific common specifications, including particular risks to address (e.g., the use of local anesthetics in fillers) and necessary control measures (e.g., sterility or long-term data). They also specify contraindications, categories of consumers to exclude, and information to include in the instructions for use and labeling, thus providing a detailed framework to ensure regulatory compliance and safety.
Table 1
Description of the Scope of Products with Specific Common Specifications
| Group Designation | Scope |
| Contact lenses | Excluding: Contact lenses containing toolsActive devicesOther articles intended to be introduced into or placed on the eye |
| Products intended to be introduced totally or partially into the human body by surgical invasive means to modify anatomy | Excluding: Tattoo productsPiercings Products to fix anatomical parts |
| Substances, combinations of substances, or items intended to fill the face, skin, or mucous membranes | Including: Means of introduction into the body only when they are prefilled |
| Equipment intended to be used to reduce, remove, or destroy adipose tissues, such as those intended for liposuction, lipolysis, and lipoplasty | Excluding: Active implantable devices |
| Equipment emitting high-intensity electromagnetic radiation (infrared, visible light, ultraviolet, for example) used for skin treatments | For example: Lasers and intense pulsed light equipment used for skin resurfacing, tattoo removal, hair removal |
| Equipment intended for transcranial brain stimulation using electrical currents or magnetic or electromagnetic fields to modify brain neuron activity | Excluding: Invasive devices For example: transcranial stimulation |
In Conclusion
The clinical evaluation of products listed in Annex XVI of the MDR represents a challenge due to the absence of clinical benefits. Manufacturers must focus on demonstrating clinical performance and risk management. The CS provides a clear and detailed framework to guide this evaluation, helping manufacturers prove the safety of their products. By rigorously applying these requirements, they can ensure both regulatory compliance and user protection.
This article was translated from its original publication in French in DeviceMed Magazine.
