Products without a medical intended purpose are the product groups listed in Annex XVI of the MDR that, despite a non-medical objective, are included within the scope of the Regulation. Products with a dual intended purpose combine a medical and a non-medical intended purpose. Special rules apply to both categories because their purpose, risk, and clinical evaluation cannot be equated with those of a classic medical device.
Annex XVI products under the MDR
Annex XVI covers certain product groups without a medical intended purpose, such as products in the aesthetic field. The MDR does not treat them like medical devices because manufacturers would have to claim a medical benefit after the fact. Rather, the legislator assigns them to the regulatory framework due to comparable risks. Common specifications can further detail the requirements for these groups, taking into account the absence of a medical intended purpose.
The manufacturer must demonstrate compliance with the safety and performance requirements applicable to the product group. The assessment focuses not on a therapeutic effect, but on acceptable safety and performance within the stated non-medical use. Clinical data may nevertheless be required, for example to substantiate risks, adverse effects, or the performance of the aesthetic application. The patient or consumer population and the context of use must be described accurately.
Dual intended purpose as a cumulative obligation
A product with a dual intended purpose has both a medical and a non-medical intended purpose. It cumulatively meets the requirements for products with a medical intended purpose and the requirements for products without a medical intended purpose. If the requirements under the MDR and the common specifications are not aligned, the stricter requirement applies. The dual role must therefore not be understood as a way to exclude part of the regulatory framework.
For the equivalence assessment, a product with a dual intended purpose may refer only to the characteristics that relate to its non-medical use. This limitation prevents clinical data for a medical indication from being used without further justification to assess an Annex XVI product. If the two uses are not achieved simultaneously in the same patient, MDR and specification requirements can be applied separately to the respective intended purposes.
Distinction from medical devices and equivalence
As a rule, equivalence cannot be demonstrated between a medical device and a product without a medical intended purpose. The different intended purpose shapes the technical, biological, and clinical characteristics as well as the requirements to be applied. A comparison must not be based solely on similar design or energy source. It must include the characteristics that are actually relevant to the respective non-medical application.
The situation may be different between a pure Annex XVI product and a product with a dual intended purpose. In that case, equivalence can be assessed based on the characteristics of the non-medical part. The medical function of the comparator product does not become a shortcut for the demonstration. This separation prevents the clinical evaluation from adopting data from a different intended purpose without sufficient justification.
Labelling and manufacturer communications must reflect the chosen intended purpose without contradiction. If a product claims aesthetic and therapeutic effects at the same time without substantiating the two uses separately, neither the correct combination of requirements nor the appropriate clinical evidence can be determined reliably. A clear intended purpose is therefore the starting point for classification, evaluation strategy, and the subsequent information for users.
Relevance for clinical trials
Studies on Annex XVI products require a research question that fits the non-medical intended purpose. Endpoints on tolerability, user-reported outcome, durability, or specific risks can differ significantly from endpoints in a therapeutic study. With a dual intended purpose, the sponsor and manufacturer must define early on which use each data collection serves. Otherwise, it will be difficult later to assign the protocol, informed consent information, and clinical evaluation cleanly.
Full-service CROs such as Mediconomics support the development of intended-purpose-specific study protocols, the delineation of target populations, the collection of product-specific safety data, and the preparation of clinical data for equivalence or performance evaluation. Their project teams can also document transparently which evidence supports the medical and which supports the non-medical product characteristics.
The associated clinical documentation should therefore not merely collect data, but assign each dataset to the correct intended purpose and product configuration. This is crucial for any later update of the common specifications or the intended purpose.
Frequently Asked Questions (FAQ)
Why does an aesthetic product with no medical benefit fall under the MDR?
Annex XVI explicitly brings certain non-medical product groups within the scope. The reason lies in their potential risks, not in any claimed medical treatment.
Does a product with a dual intended purpose have to meet both sets of requirements?
Yes. The MDR cumulatively requires compliance with the requirements for the medical and the non-medical intended purpose; where the levels differ, the stricter requirement must be applied.
Can a medical device serve as a comparator product for any Annex XVI product?
Generally not. The different intended purpose normally prevents sufficiently justified equivalence. A limited assessment may be possible when comparing with a product with a dual intended purpose.
Regulatory References
- Regulation (EU) 2017/745, Article 1(2) and (3) – covers Annex XVI products and dual intended purposes.
- Regulation (EU) 2017/745, Annex XVI – lists the product groups without a medical intended purpose.
- MDCG 2023-5 – explains the qualification and classification of Annex XVI products.
- MDCG 2023-6 – describes the demonstration of equivalence for Annex XVI products.