Insights into Annex XVI – Article 2 of 3: “Clinical Investigations of Medical Devices without a Medical Purpose
Are you navigating the complex landscape of Medical Device Regulations (MDR) concerning products without a medical purpose (Annex XVI, MDR)? Symbio Proinnovera can help!
REGULATION (EU) 2017/745 Medical Device Regulation (MDR) was implemented to set high standards of quality and safety for all MDs by ensuring that data generated in clinical investigations is reliable and robust, and that the safety of the subjects participating in a clinical investigation (and of the people using the device afterwards) is protected. Now, these high standards must also be adhered to for products without a medical purpose (Annex XVI products), including certain aesthetic products.
Conformity of Annex XVI products may be carried out with available data of an equivalent product instead of performing a clinical investigation. MDCG 2020-5 provides guidance on equivalence assessment of MDs. If this is not possible because not all data for the equivalent product is available, MDR states that for the demonstration of conformity for those products, clinical evidence regarding safety should be demonstrated.
When you conclude that data from a clinical investigation is required for your product, it is important to determine the class of your device (for classification rules see Annex VIII, MDR) as this dictates the type of submission for the clinical investigation – for example, authorization by National Competent Authority (NCA) versus notification to NCA only. As some of these classification rules (especially rules 9 and 10) assume a medical purpose for the device, other implementing regulations (REGULATIONS (EU) 2022/2346 and (EU) 2022/2347) were adopted at the same time as the common specifications to reclassify corresponding products.
Some Annex XVI products, such as dermal fillers, are classified as high-risk MDs which must undergo pivotal clinical investigations with a design and scope similar to that of Phase III studies for drug/medicinal product approval. There may be products that are considered both MDs with medical purpose and Annex XVI products, and in this case, the clinical benefit must be demonstrated during the clinical investigation.
If you are unsure how to proceed with your investigational device, Symbio Proinnovera is available to consult with you and help you determine the best path forward. We bring experience in planning and executing clinical investigations for Annex XVI products across several countries/locations and settings. From preparing a synopsis with appropriate endpoints to regulatory submission to report writing, we can be your partner every step of the way. Partner with us and we will help you seamlessly and successfully navigate the landscape of MD Regulations.
If you have further questions about clinical investigations of medical devices without a medical purpose, please reach out to us for support tailored to your needs.
