Borderline Medical Devices

December 18, 2023
Olivia Sun

Olivia Sun
Senior Consultant Regulatory Affairs

Have you ever been unsure of whether or not the device you are working with is a medical device?

Don’t worry, most of us have.

Medical devices are based on a wide spectrum of technologies. In fact, there are about 2 million different kinds of medical devices on the world market according to WHO. Devices may come in all shapes and sizes along with a variety of functionality and complexity. With today’s fast-paced advancement of new technology, it can become increasingly difficult for manufacturers to determine whether or not their device is a medical device. In this blog post, we will help you avoid common pitfalls by providing a step-by-step tutorial for qualifying your device as a medical device in the EU.

The Regulatory Framework for Medical Devices in EU

Medical devices in the EU are currently governed by two regulations: the MDR 2017/745 for medical devices and the IVDR 2017/746 for in-vitro diagnostic (IVD) medical devices. Compliance to these regulations is mandatory for new medical devices placed on the EU market, and for legacy medical devices following a transitional period.

The MDR and IVDR set the framework for managing medical devices throughout the entire device life cycle; from design and development to decommission. Being able to determine that your device is a medical device at an early stage will minimize unnecessary costs, ensure a smooth access to the EU market as well as promote safe device use.

Step 1: Determine the intended purpose of your device

The first and most important step in qualifying your device is to determine its intended purpose. The manufacturer is responsible for defining the scope of the intended purpose and assigning it to the device. The intended purpose shall be defined with clear specifications of:

  • Indications
  • Contraindications
  • Patient target group(s)
  • Intended user(s)

It is important to note that any intentional restriction in the field of application should be specified and that any claim made for a medical device must be substantiated by technical, clinical, and scientific data.

Step 2: Determine the principles of operations for your device

After defining the intended purpose, proceed to define how your device shall achieve its intended purpose. Describe the technology enabling your device to perform as intended. It is important to note that a medical device does not achieve its intended purpose by pharmacological, immunological, or metabolic means in or on the human body. Your device can therefore be ruled out as a medical device if it achieves its intended purpose by such means. However, your device could still be a medical device if it is assisted in its function by pharmacological, immunological, or metabolic means.

Step 3: Review the qualification of your device

When you have established the intended purpose and the principles of operations for your device, proceed to comparing these to the definitions of medical device and IVD medical device in Article 2 of MDR and IVDR. Medical devices, IVD medical devices and accessories to such devices are characterized by one or more distinct medical purpose(s) and are used for the benefit of individual patients.

If you are still uncertain if your device is a medical device, we recommend reviewing available guidance published by the Medical Device Coordination Group (MDCG) on borderline medical devices to better determine if a medical purpose is assigned to your device. A few common borderline medical device types are highlighted below.  

Products Without an Intended Medical Purpose

Products without an intended medical purpose are generally not considered medical devices. However, the European Commission has included some products used for aesthetic purposes within the scope of MDR. Such products, which include dermal fillers and aesthetic contact lenses, are listed in Annex XVI of MDR. Manufacturers of such products are obliged to comply with applicable parts of MDR and relevant Common Specifications.

Medicinal Products

Medical devices achieve their principal intended action by physical means (e.g. mechanical action, physical barrier or heat transfer), and not by pharmacological, immunological, or metabolic means.

Devices achieving their principal intended action by pharmacological, immunological, or metabolic means qualify as medicinal products. But regardless of how the principal intended action is achieved, any substance used in or administered to human beings to make a medical diagnosis also qualify as a medicinal product. Further guidance is provided in MDCG 2022-5.

Medical Device Software

Not all software used in healthcare are considered medical devices. Software, used alone or in combination, shall have a medical purpose on its own and perform actions to benefit individual patients to qualify as a medical device software (MDSW). Furthermore, software with functions restricted to storage, archival, communication, simple search or lossless compression of data are generally not considered medical devices, although such devices may be subject to other regulatory frameworks in certain regions.

It is also important to note that software that is not a medical device in itself may still fall under the scope of MDR or IVDR if it qualifies as an accessory for a medical device. Further guidance is provided in MDCG 2019-11.

Step 4: Reach out to a medical device professional

Hopefully steps 1-3 have provided some useful insights for performing your medical device qualification. However, we do recognize that some cases are more complex than others. If you are still unsure of whether or not your device qualifies as a medical device after reading this blog post, we recommend reaching out to a medical device professional for assistance. Members of the Regulatory Affairs team at Key2Compliance share a wide variety of experiences within the medical device industry. Click here to get in touch with us and let us assist you in your medical device qualification.