How are medical devices without an intended medical purpose regulated under the MDR Annex XVI?
The Medical Devices Regulation (MDR) 2017/745 has significantly changed the European Union’s (EU) regulatory landscape for medical devices.
While prioritizing patient safety and efficacy, this regulation introduces a fascinating aspect: including medical devices without an intended medical purpose. Let’s explore the key highlights of the MDR Annex XVI and delve into the world of these intriguing devices.
What is new?
The MDR 2017/745 replaces the previous Medical Devices Directive (MDD) and enforces stricter requirements for manufacturers, notified bodies, and competent authorities.
One notable change is the expanded scope of medical devices to include products without an intended medical purpose, a departure from traditional definitions – a scope reflected under the MDR Annex XVI.
Medical Devices without an Intended Medical Purpose:
Under the MDR Annex XVI, certain products are categorized as medical devices even if they lack an intended medical purpose. Examples include:
- Contact lenses without correction of vision (ex: colored contact lenses)
- Devices to modify the anatomy or fixation of body parts (ex: subdermal implants such as breast implants)
- Facial and dermal fillers for skin enhancements (ex: dermal fillers)
- Equipment for body shaping and fat reduction (ex: liposuction equipment)
- High-intensity radiation devices for skin treatment, such as IPL (Intense pulsed light), lasers and infrared equipment (ex: tattoo or hair removal lasers, equipment for hair removal or skin rejuvenation).
- Non-invasive brain stimulation devices (ex: devices for transcutaneous electrical nerve stimulation (TENS) for aesthetic purposes)
And how are these medical devices from MDR Annex XVI commonly classified?
Discover the classification of these devices according to the rules outlined in MDR 2017/745 Annex VIII. However, it’s important to note that not all rules can be applied. For instance, rules 9 and 10, which pertain to active therapeutic and diagnostic devices, assume a medical purpose.
To address this, a Commission Implementing Regulation (2022/2347) was introduced to reclassify relevant devices alongside the Common Specifications. Let’s take a closer look at the classification of specific product classes:
- Body shaping devices are categorized as Class IIb, as detailed in Section 4.
- Devices for skin rejuvenation, hair removal, and similar purposes may fall under Class IIa or IIb, depending on the application. This classification is explained in Section 5.
- Equipment for transcranial brain stimulation is classified as Class III and is covered in Section 6.
Annex XVI Medical devices: key regulations
Here are the key regulations of medical devices without an intended medical purpose according to the MDR 2017/745:
- Safety and Performance: Ensure devices are designed and manufactured for safe and effective use, with a risk analysis and mitigation measures in place.
- Conformity Assessment: Carry out a conformity assessment procedure to demonstrate compliance with relevant requirements, potentially involving a notified body.
- Technical Documentation: Prepare and maintain documentation showcasing device conformity, including design, intended purpose, manufacturing processes, and risk management.
- Post-Market Surveillance: Establish a system to monitor and analyze device performance and safety, promptly investigate complaints or adverse events, and take corrective actions.
- Unique Device Identification (UDI): Assign a unique device identifier (UDI) to enable traceability and provide corresponding information in a UDI database.
- Clinical Evaluation and Investigation: Conduct a clinical evaluation based on available data to assess device safety and performance, with clinical investigations if needed.
- Labeling and Instructions: Properly label devices and provide clear instructions for use, including intended purpose, handling, storage, and relevant warnings or contraindications.
The MDR 2017/745 revolutionizes the medical device industry by emphasizing safety, performance, and post-market surveillance.
Notably, the regulation expands its scope to include medical devices without a medical purpose. By encompassing these devices, the MDR addresses the evolving landscape of healthcare technologies and their impact on human health.
By partnering with MDx CRO, manufacturers can ensure compliance with the MDR and successfully bring their Medical Devices without an Intended Medical Purpose to the European market.
MDx CRO offers expertise in navigating the complex regulatory landscape, providing guidance and support throughout the compliance process. Together, we can ensure that these innovative devices meet the necessary safety and performance standards, opening doors to new opportunities in the European healthcare market.
FAQ
How does MDR define “intended medical purpose” for medical devices?
The MDR 2017/745 focuses on the term “intended purpose”, which means the use for which a device is intended according to the data supplied by the manufacturer on the labeling, in the instructions for use, or in promotional materials.
While the MDR does not provide an explicit definition for “intended medical purpose,” it is generally understood as the purpose for which a medical device is intended to be utilized within the medical field. The intended purpose of a medical device refers to the specific medical functions it is intended to perform, such as diagnosis, treatment, monitoring, prevention, or alleviation of disease or injury.
Are there any exemptions or special considerations for medical devices without an intended medical purpose?
Yes, the MDR 2017/745 provides some special considerations for medical devices without an intended medical purpose. The main considerations are:
• Manufacturers of products without an intended medical purpose shall comply with the relevant common specifications for those products, based on Article 9(4) of MDR. The common specifications related to these products shall address, at least, the application of risk management as set out in Annex I of MDR and, where necessary, clinical evaluation regarding safety.
• Regarding the clinical evaluation, the requirement to demonstrate a clinical benefit in accordance with Chapter VI and Annexes XIV and XV of MDR 2017/745 shall be understood as a requirement to demonstrate the performance of the products without an intended medical purpose, according to article 61(9). Clinical evaluations of those products shall be based on relevant data regarding safety, including data from post-market surveillance, post-market clinical follow-up, and, if applicable, specific clinical investigations. Clinical investigations shall be conducted for these products unless reliance on existing clinical data from an analogous medical device is duly justified.
• Considering Annex I of MDR 2017/745, Chapter I(9), the general safety requirements established in Sections 1 and 8 shall be understood to mean that these devices, when used under the conditions and for the purposes intended, do not present a risk at all or present a risk that is no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons.
Are there any specific labeling or instructions for use (IFU) requirements for medical devices without an intended medical purpose under MDR 2017/745?
Yes, devices without an intended medical purpose have specific requirements for IFU, but not for labeling. According to Annex I of MDR 2017/745, point 23.4 (x), information regarding the absence of a clinical benefit and the risks related to the use of the device should be included in the IFU.
