Hello all, welcome to the first blog post from a trustee of the WFA. Hopefully there will be more blog posts from a variety of players, coaches, officials and others, but the task of the first trustee post has fallen to me. I thought I’d make life easy for myself and tackle the issue of Chair Compliance. This may mean nothing to you, may be a phrase you’ve heard talked about, but not sure what it means, or you may be well versed on the subject. Since there has been a fair amount of rumour, discussion and unrest around the subject within Powerchair Football, I thought it was best tackled head on and let everyone know the situation. It will also give us a chance to explain what we are doing about it and its implications for the sport.

Chair compliance is actually just a way of saying ‘do chairs meet the rules for selling goods in the EU’. The EU has rules on many things that are sold from food, to in this case, medical devices (I will explain why a Powerchair Football chair is a medical device in a moment). For food there are rules about which pesticides can be used, the temperature it can be stored at and the environments in can be prepared in. All of these are primarily about safety and wellbeing. The same reasons apply to medical devices and the regulations were updated in May 2017 to define what a medical device is and to say what is required of manufactures if they wish to meet the standards to be able to sell them in the EU. The new regulations called  The EU Regulation on Medical Devices 2017/745 (MDR’s) fully comes into force in May 2020 and replace existing ones (there is a long transition period to allow manufacturers to comply). Manufacturers should already be complying with the existing regulations, however as these are now obsolete, the focus should be on the new ones as in many cases you can backdate the compliance.

This issue is complicated enough on its own so for the sake of argument I’m going to assume that Brexit is either delayed further, doesn’t happen or if it does then the medical device regulations are adopted either permanently or at least temporarily (The Government White paper suggests as much so this is highly likely to be the situation after any Brexit whatever form it may take).

So back to Medical Devices. What is a medical device? What is a sports chair? Is there a difference? Well I’m going to answer them in the wrong order. A sports chair is just a phrase used to describe any wheelchair used in a wheelchair sport. There is no legal definition and ultimately is just a general description of a wheelchair used for sport. I know it has been used within this discussion as a reason why Football Powerchairs are exempt, but sadly it’s not true. Yes Football Powerchairs can be described as Sports Chairs, but that doesn’t mean they aren’t also Medical Devices which has a legal definition. That definition is quite long but the important part for us is highlighted in this excerpt.

For the purposes of this Regulation, the following definitions apply:
(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 donations,
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.



As you can see this means that Football Powerchairs are indeed Medical Devices and therefore need to comply with regulations. The good news though is that most Football Powerchairs will fall into the least regulated class of device within the MDR’s. This means manufacturers can follow the process and self certify the majority of the regulations.

From my research into this issue I think it’s highly unlikely that any major changes to chairs will be required to meet the compliance regulations, but some will be and the registration to the EU database will need to be completed.

What the WFA doing about it? Well we don’t have an official role in any of these processes, but as the representative organisation for players and clubs we are doing our best to help educate and inform everyone so  we can move towards a solution. This blog post is part of that. We have also issued more detailed guidance to manufacturers and importers and we are in communication with the MHRA (The Medicines and Healthcare products Regulatory Agency) which regulates medical devices in the UK. Through this we are signposting manufacturers and importers to the right information and places of support to meet the regulations. We are also liaising with FIPFA on this as a wider issue internationally.

Should I panic if my chair isn’t compliant? Although I have no real authority to say this, my answer is no. I’ll explain why. All the manufacturers and importers we have spoken to are engaging in the conversation and showing a willingness to sort this issue out. The MHRA are aware of the issue and have been for some time and working with us to solve it. They haven’t taken any enforcement action that we know of yet and we have had no indication they are going to either. IF any action is taken, we have had indications that it would only be against manufacturers NOT clubs or players so I don’t believe we are in any danger of any chairs being seized or banned. This is only my personal view, but one that is as informed as it can be at the moment. I can’t really include everything I’ve read and learnt in a single blog post (there is a lot!!), but this is my current understanding.

So in summary, we have an issue as a sport which we are trying to solve and we are working hard to do so. The people that need to take action have started the process and I’m confident there can be a successful solution to all of this fairly promptly. I’m happy to answer any questions and I’ll try to reply quickly, but please bear with me if I get a lot. I would advise against bombarding manufacturers with questions, as they are all addressing the issue and as part of that process, highly likely to communicate with customers when there is something to communicate. I’m hoping this blog post will offer clarity rather than create a lot of worry and questions, but please ask if you need to.

Yours in Sport,

Alex Dowding

WFA Trustee

[email protected]