Annex XVI devices: MDR requirements and deadlines

To be placed on the EU market, certain products without an intended medical purpose have to comply with the Medical Devices Regulation (MDR). Annex XVI to the MDR lists six product categories, sometimes referred to as “Annex XVI devices” or “aesthetic devices”, to which the MDR applies. The MDR demands that such products comply also with the requirements listed in the relevant Common Specifications, issued by the European Commission. MDCG Guidance 2023-5 provides further insights on these products, with guidelines and examples on classification of Annex XVI devices.

MDR Annex XVI devices: EU requirements

Products listed in Annex XVI must comply with the MDR requirements as well as with the Common Specifications (CS) provisions. Nonetheless, there are some differences to consider compared to medical devices.

Classification-related aspects

Classification rules 9 and 10 cover active therapeutic and diagnostic devices, which have a medical purpose. Consequently, rules 9 and 10 do not apply to Annex XVI devices. Rule 13 (“all other active devices”) would cover such products, collocating active Annex XVI devices under class I.

However, to properly address the risks associated with products falling in Annex XVI groups 4, 5, and 6, specific requirements have been introduced by the European Commission. Following the Commission Implementing Regulation (EU) 2022/2347, products falling in the above mentioned groups must be classified as indicated below:

• Group 4 products (body shaping): class IIb
• Group 5 products (high intensity electromagnetic radiation): class IIb, unless intended for hair removal, in which case they are classified as class IIa
• Group 6 products (brain stimulation): class III

Clinical evaluation and clinical investigation

As per MDR requirements, manufacturers of Annex XVI devices must plan and conduct a clinical evaluation. Generally, clinical data must demonstrate safety and performance of devices, including clinical benefits. Since Annex XVI devices do not have an intended medical purposes, clinical data do not have to demonstrate clinical benefits. Still, their clinical evaluation must demonstrate their performance and safety.

To collect clinical data, Annex XVI manufactures must conduct a clinical investigation, unless they can duly justify reliance on existing clinical data from an equivalent device. In these terms, MDCG 2023-6 (guidance on demonstration of equivalence for Annex XVI products) clarifies that it is not possible to demonstrate equivalence between a device without an intended medical purpose and a medical device.

Common specifications: risk management

Common specifications for Annex XVI consist of two articles and seven annexes. The first annex applies to all products without a medical intended purpose. This annex includes stricter risk management requirements for Quality Management System (QMS) and Technical Documentation as well as indicates some specific information on the product labels and IFUs.

The remaining six annexes each corresponds to one of the six product groups listed in Annex XVI. Each annex sets requirements tailored to that type of product. This includes:

• ad hoc risks to be considered during risk analysis
• risk control measures to be implemented by manufacturers
• list of detailed information to be added on the labels and IFUs of the product

Transitional period to the MDR: upcoming deadline

The Common specifications grant a transitional period to products which fall under the MDR scope as Annex XVI devices but which are not yet in compliance. This grace period varies:

1. Grace period applicable to products that require the intervention of a Notified Body and for which the manufacturer needs to conduct a clinical investigation: 31 December 2029, subject to conditions.
   • By 22 June 2024, the sponsor must have received the authorisation to start the clinical investigation and must start it within 23 December 2024.
2. Grace period applicable to products that require the intervention of a Notified Body but that do not require a clinical investigation: 31 December 2028, subject to conditions.
3. Grace period applicable to products that were covered by an MDD CE Certificate: 31 December 2027 or 31 December 2028 depending on device class and subject to conditions.

More details on the Annex XVI transitional periods:

Flowchart transitional periods Annex XVI - Final 12.03.2024.pdf_page1

 

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