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Altering CE marked orthoses

Discussion in 'Biomechanics, Sports and Foot orthoses' started by davidl, Apr 28, 2010.

  1. davidl

    davidl Member

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    Hi folks,
    This message is really intended for UK/European podiatrists who may have come up against the CE conformity marking regulations. I have been asked to respond to a medical devices safety alter regarding off label use of CE marked mass produced products (including alteration) by my NHS Trust patient safety team .

    Looking at the various regulations I understand (possibly!) that if a BESPOKE CE marked device is altered/adjusted by a healthcare professional it is not within the scope of the relevant regulations, however, if a mass produced orthosis is altered, it is NOT classed as a bespoke device even if it is altered by a healthcare professional.

    Our Trust is saying that if we are indeed going against the regulations in some way, we need to do a risk assessment for each instance and obtain written patient consent, plus a whole host of other NHS red tape probably.

    My opinion is that it shouldn't really matter as the NHS are not marketing/selling the devices and the adjustment in a clinical setting is not covered by such regulations unless you are doing so to a device which specifically is not designed to be altered. :confused::confused:

    What say you all?

    regards, David
    ps for reference: Council Directive 93/42/EEC, MHRA guidance notes 9 and 16 are the documents I have been looking at
  2. Lawrence Bevan

    Lawrence Bevan Active Member

    Hi David

    This is rearing its head in my area also and Im sure it will be in all areas. Good old Care Quality Commission Quango-crats

    As far I see it if you alter a non-bespoke CE marked device you make the existing CE marking defunct and create a new device that requires a CE mark. I suppose the way round this is to only use manufacturer provided CE marked wedges or pads and apply them in a manner that is documented as part of the CE mark for that device. EG Vasyli supply wedges with theirs.

    If you do an individual alteration such as grinding or adding a individually designed pad/wedge then, strictly speaking, all the red-tape that applies to CE marking of devices applies your new one - each and every instance.

    Goodbye cheapie pre-fabs and hello bespoke...again.

  3. davidl

    davidl Member

    Hi Lawrence

    I agree it will be spreading to many areas soon - watch out NHS practitioners, but perhaps more so private practitioners! (see below)

    I feel it might not apply in NHS because;

    Quote MHRA guidance notes 16

    "the professional activity of prosthetists and orthotists aligning and fitting prosthetics/orthoses for individual patients is outside the scope of the Regulations"


    "Manufacturers and healthcare establishments supplying devices with the intention of placing them on the market i.e. the first making available in return for payment.... with a view to distribution, use or both on the community market come within the scope of the Regulations"

    Certainly for individual patients, and I do not think we are placing our NHS devices on the market, but perhaps might be in private practice.

    Any thoughts?
  4. deco

    deco Active Member

    Hi David, Lawrence

    As far as I am aware you can alter CE marked devices without making the CE marking redundant provided you follow the guidlines issued by the manufacturer. So, if you use a heatgun to modify a prefab insole the CE marking should not be effected. This is assuming that you have followed the manufacturers guidlines and use the device in the way it was intended, ie the insole is not used as a helmet.

    If you remove the CE marking, and replace it with your label then you become the manufacturer and things get a bit more complicated. This does happen a lot, practitioners replace CE labels on devices issued by the manufacturers with their own company logos etc.


  5. Lawrence Bevan

    Lawrence Bevan Active Member


    i dont think you read my posting - yes if you alter a device according to the manufacturer instructions then you will comply with the CE marking as the "instructions" form part of the CE certification.

    If you however take a "slimflex" and grind it, add a generic wedge and a cover you have taken a CE marked device and altered it beyond the documented CE certification. It would then technically require a new one. And there is a full process for this. It could well be if you then certify it and then it is adjusted at another appointment it might need another "certification" !

    Is all legal jargon and open to interpretation and the only place it ever gets decided is the last place you want to end up!

    Its also complete crap that achieves absolutely nothing except provide jobs for pen-pushers in Brussels (and now NHS managers). It doesn't even govern quality - I should imagine every component in those Toyota cars that were recalled had a CE mark.
  6. deco

    deco Active Member

    Hi Lawrence

    I agree that it is all open to interpretation,

    I have never used slimflex myself but does the supplier not indicate that they are suitable for a reasonable amount of adjustment/modification? What is its CE certification?


  7. davidl

    davidl Member

    Hi Declan and Lawrence

    This is interesting as I tried earlier this week to get some major suppliers to give information about what modifications could be done to their pre-fabs. None could give me a straight answer.

    When I simply asked them if their "X" othosis was suitable for grinding and adding posts they openly said yes but when I started asking about the effect on CE marking, they backed down and were a lot more guarded. I notice also that some major orhtoic suppliers are marketing products which haven't even got a CE mark!

    I am awaiting an email from MHRA regarding this and will let you know the outcome.

    Cheers, David
  8. deco

    deco Active Member

    HI David,

    Thats interesting,

    I also have literature somewhere from the medical devices directive in Ireland that links to EU law somewhere, this is something that I have had to deal with before but in a different context,

    It is a bit of a minefield where unfortunately common sense doesnt prevail, it is in the suppliers (and clinicians) interest to resolve this and provide suitable documentation if required


  9. davidl

    davidl Member

    Have just had a reply from MHRA.

    The scenario I gave them was altering size and angle of a mass produced insole to suit a particular patients requirements.

    see below

    Dear David

    A very quick opinion would be that the activity you describe would be outside the scope of the MD Regulations. The only circumstances I can think of in which it might be covered would be if the manufacturer of the mass produced device was not indicating that it needed to be adapted or adjusted to fit. In that instance then it could be that by changing the intended purpose of the device the clinician is manufacturing a new device in which case if it was used on a patient from a different legal entity placing on the market could be occurring and it would therefore be covered by the Regs. This scenario seems pretty unlikely but if you need more advice on it we can consider in more depth and let you have further views.

    Hope this is helpful. We are happy to give whatever general advice we can on the Medical Devices Directive and UK implementing Regulations. However any views expressed by us on their interpretation represents our best judgement at the time based on the information available. It is not intended to be a definitive statement of law that can only be given by the courts. Accordingly we would always advise you to seek the views of your own professional advisers.

    So, perhaps we need to establish which devices are intended NOT to be altered??? In any case I agree this is all so grey an area that only a test case may establish what is or isn't acceptable.

    Regards, David
    ps please excuse the spelling mistakes in previous post - I do know how to spell orthosis, just too early in the morning to conquer typing dyslexia.:dizzy:
  10. Lawrence Bevan

    Lawrence Bevan Active Member


    Its the manufacturers that decide that isn't it? If the orthotic is "alterable" it will come with instructions on safely how-to.

    Note manufacturers - not suppliers.

    I would say though that some devices have always been alterable under the manufacturer guidance - Vasyli and Formthotics for instance but obviously this would also mean using their wedges and pads not ones own.

    Anything that is a glorified sockliner - Slimflex for instance is alterable but does the manufacturer agree and describe how?

    Love how they appended the get out clause! :)
  11. davidl

    davidl Member

    You have hit the nail on the head Lawrence, we need to know what can and can’t be done from the manufacturers, but I fear that this could end up being way too complicated if we take into consideration all the types of adaptation we might want to be covered.

    If we take slimflex for example, Algeos website says "can be used with wedges and components to create a custom device if required" So wedges OK and components (whatever that covers) but not grinding.

    Now, they are marketing the slimflex as a 'First Line' brand - (their own?) but is it Algeos who are stating they are adaptable or the manufacturer??

    I understood that if the supplier (rather than the maker) is branding and marketing the insoles as their own range, they share the responsibility - but know what you mean.

    Also the regulations state that altering a CE marked device is NOT classed as a custom device, despite what the website says. (Are slimflex CE marked by the way?)

    Perhaps it needs us pods to push the suppliers and manufacturers to more clearly state what can or can’t be done to a pre-form. Are there any forum members who work for manufacturers or suppliers/distributors of stock insoles who can jump in here to clarify?

    Still confused!!!!!
  12. deco

    deco Active Member


    if the suppliers take a prefab and put on their own labels for distribution they become the manufacturers

  13. Lawrence Bevan

    Lawrence Bevan Active Member


    modified pre-fab is not "bespoke" thus within the remit of CE regulations (where bespoke might be exempt if not for sale)

    Modifing CE marked device in accordance with manufacturer instructions + manufacturer supplied material = still compliant

    Modifing CE marked device in manner not described by manufaturer or re-brand/re-seller = no longer CE marked and must be CE marked internally

  14. davidl

    davidl Member


    only if "placing medical devices on the Community market" - "with a view to distribution, use or both on the Community market" this to me implies issuing a device on the NHS modified or not is not placing the device on the Community market" Really a modified stock item should be bespoke if for a particular patient.

    I'll see if I can find out what the Community market actually is.
  15. David Smith

    David Smith Well-Known Member

    Gordon Bennett Get a life, get some balls and do what you think is correct for the situation and stop worrying about what's might going to happen in some imaginary world in your no risk taking heads otherwise you'll end up like this teacher who is too busy or too scared to save a boys life for fear of some imaginary litigation case.
  16. Lawrence Bevan

    Lawrence Bevan Active Member

    I totally agree with your sentiment dave!

    However there is big drive by the Care Quality Commission on this issue at the moment (in the NHS)

    These are just some of the issues that come up. I know it sounds crazy but it is the kind of crap that comes up.
  17. davidl

    davidl Member

    Yes, indeed.

    David please target your abuse to the NHS/Goverment who are wasting the clinicians time having to go through all of this, not the clincians who are trying to maintain the ability to prescribe what the patient needs, as you correctly suggest, is what should be happening.

    Regards, David
  18. Greg Quinn

    Greg Quinn Active Member

    Just for clarification, it is perhaps worth bearing in mind that CE product marking for medical devices is a European (legal) quality control assurance for a product with standard features, appropriate for general sale. It is an indication that it is 'suitable for purpose' along with any included instructions for modification. Custom made devices DO NOT fall under such arrangements but instead are covered by a legal requirement for a detailed Quality Assurance process (ISO 9000:2000 or similar) that is regularly audited by an approved body, such as the BSI within the UK. The MHRA (formerly the MDA) provide excellent support for those practices or businesses involved in the manufacture of orthoses. Whether or not to ignore such legal regulations is not really the point here. The processes involved, and yes they can be costly and time consuming, represent best manufacturing practice. E.G. Tracebility of materials, standarisation of material quality and manufacturing equipment callibration etc. Protection of the patient, the business & the prescriber is at the heart of legislation like this. Having said that, all such regulation can prove to be off-putting and is often perceived as excessively bureacratic.
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