Is this a medical device or not?

[DutchMarten]

Hello all,

I work for a company that make hoists to transfer patients (or more generally people with disability that prevent them from walking themselves) from bed to toilet or from bedroom to hall etc. This being classified as a medical device we conform to EU MDR. All other manufacturers of similar devices (that make or market these in the EU) conform to the EU MDR.

Now the other day I spoke to someone who works at another company that make a hoist like product to transfer people from the airport gate to the chair in the airplane. He said they don't conform to the EU MDR as they reason it is outside the scope and not a medical device. He said that it is because it is used in an airport and not in a healthcare setting (i.e. a hospital or carehome etc.).

For me this makes no sense. It is a device with an intended medical purpose regardless of the place where it is used. Very strictly interpreting the EU MDR you could in some strange way stretch to say that if you market it specifically not to people with disability it is not a medical device because it is simply an alternative way of getting on a plane. However this still seems to not make sense if it is such a near identical product to one that is used in say a hospital. And even then they do in fact market it a device for passengers with reduced mobility.

He was adamant it is not a medical device, I'm finding it very hard to believe it is not but I also have to say I am not knowledgable in regulations and standards concerning aviation. It is not fixed to an airplane, it enters the airplane but only while it is on the ground and it could be used in another setting than an airport even though it is designed to be used in an airport.

I'd like to hear your thoughts; in your opinion is this a medical device or not?

Thank you in advance!

 

[ChrisM]

Does the device provide medical or therapeutic benefit? My first thought is that a hoist is not designed to be used only by "medical professionals" and it is not a medical device unless somewhere in legislation it has been prescribed as such. I will be interested to know what others have to say.

It probably comes under the Machinery Directive rather than Medical Devices; have a look from Page 13 onwards in the pdf accessible via thisl ink:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745

 

[Billy Milly]

MDR, art.2, (1)
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donation, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

If the intention of the device is to (phisically) help (in the broadest sense) a person in improving or mitigating their medical condition, it is a medical device. Where is it used? Doesn't matter.

 

[CharlieUK]

The starting point is that all equipment designed for lifting persons falls under the Machinery Directive.

It's only if there is a function that puts it under the MDR that the Machinery Directive (MD) then ceases to be applicable as per MD Article 3.

 

[John Predmore]

The analogy I explored was a hoist used to raise/lower a frail/disabled person from/into a swimming pool. The answer from the AI bot is given, but you may want to do your own research. Since the design/manufacturer often has little control over end-use, I personally would err on the side of higher design/risk management controls.

"FDA Perspective
Pool lifts used in public swimming pools, spas, or aquatic facilities are designed for accessibility compliance with the ADA (Americans with Disabilities Act) and are not intended for medical treatment. Therefore, they fall outside the scope of FDA medical device regulation.

• FDA does not regulate pool lifts as medical devices.

EU MDR Perspective

• Pool lifts are not subject to MDR classification or conformity assessment procedures.
• However, they must comply with general safety and performance requirements under the EU’s broader product safety framework, especially if they are used in public facilities.
• If a pool lift includes features intended to assist individuals with medical conditions (e.g., for rehabilitation), it may be subject to review under the MDR."

However, answer to a different question, "Stair lifts are classified as Class II medical devices under FDA regulation 21 CFR §890.5150, specifically categorized as "powered patient transport" devices. This classification was established to ensure they meet safety and effectiveness standards for medical use, particularly for individuals with mobility impairments."

 

[Billy Milly]

Thank you John and Charlie for showing me/us a different perspective. I could conclude that the underlying regulation depends on manufacturer's claims - are lifts intended only for disabled or for 'general public', including e.g. lazy or elderly users (which are not medical conditions by themselves).

 

[d_addams]

The intended use in the hospital setting for patients receiving care in the hospital makes this under the EU MDR purview. From an academic standpoint, the use cases and use conditions in a hospital setting may be different than those in other settings (even though to the layperson the intended use seems identical).

From a practical standpoint, hospitals will likely be required to only source lifts that have followed the EU MDR to ensure clinical risk management has been applied for the product. One example is a regulation in the UK that requires application of clinical risk management to certain items used in the facility even if they are not classified as medical devices. The native regulations for those products would not necessarily be required to apply clinical risk management. That seems pretty analogous to this situation. (i.e. I didn't need to do clinical risk management for this product when I sold it to someone else, why is this hospital asking for application of 14971 if this isn't a medical device).