Devices Without an Intended Medical Purpose under MDR 2017/745: A Guide for Manufacturers
Annex XVI MDR Guide for Non intended Purpose Devices
Regulation (EU) 2017/745 (MDR), in essence, is based on medical devices – devices designed with an intended medical purpose. At the same time, the regulation covers some product categories which are not designed for a medical purpose but have similar characteristics, risk profile or interaction with the human body. These products are included in Annex XVI of the MDR and most of the regulations, which apply to medical devices in general, apply to these products too. The purpose of this document is to give manufacturers an overview of how the devices from Annex XVI are regulated according to the MDR.
What Are "Medical Devices Without Intended Purpose"?
Products specified in Annex XVI of the MDR, even though they do not have a medical purpose, interact with the human body similarly to how medical devices do. According to the European Commission, since there can be risks related to such products that are similar to risks related to medical devices (tissue changes, energy delivery, body contact), they should be regulated according to the MDR. The most common types of such products are:
Non-corrective colored contact lenses (cosmetic use only).
Devices that modify body contours through implants or subcutaneous fillers.
Equipment for the reduction of adipose tissue (e.g., liposuction machines) and high intensity electromagnetic radiation devices (e.g., lasers, IPL) for aesthetic purposes.
Brain stimulation equipment which is non-invasive in nature and used for non medical purposes.
While not intended for the diagnosis or treatment of any disease condition, because of the impact on the body, there are health and safety issues that arise.
Why Is MDR Applied To Such Devices?
“Intended medical purpose” is the primary criterion of application of the MDR; however, Annex XVI acts as an exception: it includes devices without any intended medical purpose but with similar risk/technological characteristics. This approach is based on the risk associated with use of such devices for the person. For instance:
Contacts with tissues, subcutaneous administration, access through surgery, energy administration and/or alteration of anatomy all involve inherent risks.
The Regulation specifies that although therapeutic benefit is absent, safety and performance shall be demonstrated.
Thus, manufacturers should comply with the same requirements concerning regulation of Annex XVI devices and medical devices.
Annex XVI Product Groups And Examples
The Groups of Products Without an Intended Medical Purpose as referred to in Article 1(2) of the Medical Device Regulation (EU) 2017/745:
S. No. | Product Group | Description |
|---|---|---|
1 | Contact Lenses or Similar | Contact lenses or other items intended to be introduced into or onto the eye. |
2 | Anatomical Modification Implants | Products intended to be totally or partially introduced into the human body through surgically invasive means to modify anatomy or for fixation of body parts (excluding tattooing products and piercings). |
3 | Dermal Fillers | Substances, combinations of substances, or items for facial or other dermal or mucous membrane filling via subcutaneous, submucous, or intradermal injection or other means (excluding tattooing). |
4 | Fat Reduction Equipment | Equipment intended to reduce, remove or destroy adipose tissue, e.g., for liposuction, lipolysis, or lipoplasty. |
5 | High-Intensity Radiation Devices | Devices emitting high intensity electromagnetic radiation (infra red, visible, UV), such as lasers or intense pulsed light, for skin resurfacing, tattoo or hair removal, or other skin treatments. |
6 | Brain Stimulation Equipment | Equipment for brain stimulation using electrical currents or magnetic/electromagnetic fields that penetrate the cranium to modify neuronal activity. |
Classification & Reclassification Of Annex XVI Devices
Even though classification into MDR usually involves the device’s intended use, certain classification rules exist for Annex XVI devices.
General rules of classification provided in Annex VIII are applicable to those devices, except for active devices without an intended medical purpose, which are modified.
According to Regulation (EU) 2022/2347, certain active devices listed in Annex XVI are being reclassified:
Devices emitting high intensity electromagnetic radiation for treating the skin are classified Class IIb, except when solely intended for hair removal – Class IIa.
Devices used to reduce fat tissue are classified Class IIb
Devices used to stimulate brain (penetrating the cranium) are classified Class III
Hence, it becomes clear which risk class the manufacturers should choose.
Key MDR Requirements Applicable To Annex XVI Devices
The manufacturers of Annex XVI devices are required to meet most of the MDR requirements by virtue of their action, including:
Implementation of a Quality Management System (QMS) that is appropriate for the class of a device, as required by MDR Article 10(9).
Appointment of Person Responsible for Regulatory Compliance (PRRC) in accordance with MDR Article 15.
Development of technical documentation, including demonstration of safety and performance (if the device does not have a medical purpose, it is not a clinical benefit).
Compliance with the General Safety and Performance Requirements (GSPRs), particularly GSPR #9, which is aimed at balancing the risk benefit of devices that do not have medical purposes.
For devices that do not have medical purposes, the manufacturers should instead demonstrate performance and safety by means of clinical investigations, where applicable, and post market clinical follow up.
Conformity assessment and CE marking in accordance with their classification and Notified Body. In addition, manufacturers also have to comply with the Commission Implementing Regulation (EU) 2022/2346 (CS): The CS details the specific requirements for Annex XVI devices, including risk management, labelling, performance, and post market clinical follow up.
Transitional Provisions & Deadlines
Manufacturers should be informed of important dates:
CS under Regulation 2022/2346 will apply from 22 June 2023 for devices which do not require Notified Body involvement.
Transitional deadlines for devices which require Notified Body involvement depend on whether a clinical investigation is planned:
Firstly 22 June 2025 for devices without trial, now extended till 31 December 2028.
Secondly 22 June 2028 for devices with a clinical investigation plan, now extended till 31 December 2029.
Practical Steps For Manufacturer Compliance
Assess the applicability of Annex XVI: Look through the groups of products listed and see whether your device is covered by this annex.
Classify the device according to MDR requirements: Identify whether the device is subject to MDR, whether it is an active device, and whether it is regulated by Regulation 2022/2347.
Ensure QMS is established/updated and assign the PRRC: Establish the QMS in accordance with MDR Article 10 and identify a qualified PRRC in accordance with Article 15.
Develop technical documentation and conformity assessment plan: Decide upon the conformity route that corresponds to classification and consult a Notified Body if necessary.
Determine compliance with safety and performance: For devices which do not have a medicinal use, determine the safety and performance based on relevant evidence; ensure compliance with CS of Regulation 2022/2346.
Establish the system for post market surveillance and conduct follow up: Develop a system for post market surveillance; collect data after putting the device on the market; update documentation regularly.
Monitor the changes in legislation and updates in CS: Annex XVI can be supplemented through delegated acts; CS and transitional period may change.
Register the device and economic operators: Register your device in the EU database (EUDAMED) and perform economic operator obligations under MDR.
Conclusion
However, for those who make medical devices which do not have a medical purpose, it is difficult but understandable what the regulation is in the MDR context. Acknowledging the fact that your products can be classified in Annex XVI, knowing the proper classification, completing the QMS and the conformity assessment process, and being in accordance with the Common Specifications will help to become compliant with the regulations and sell products in the EU safely. It is important to be aware of transitional deadlines and changes in the regulation to stay away from non compliance risks.
How Morulaa Can Help
Morulaa assists the manufacturers of Annex XVI devices in complying with the requirements of the MDR through regulatory support. This includes helping with setting up or upgrading your QMS, creating complete technical documentation, and ensuring that you prove the safety and performance of the product through clinical evaluations. The experts from Morulaa will ensure your device conforms to the Common Specifications (EU) 2022/2346 and EUDAMED registration.
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