Introduction written by Dr Barend ter Haar, Director of BES Healthcare, a BHTA member

In the light of the failure of certain breast implants, the European MDD was replaced by the EU MDR a few years ago to strengthen safety considerations across all medical devices. The required technical files for medical CE marking have, as a result, needed to have much more clinically related data attached to them, and the risk elements have been strengthened. However, with any new lengthy legislation, inevitably some interpretations were or are not anticipated.

The EU MDR has one reference to combining products, in Clause 14.1: “If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system shall be safe and shall not impair the specified performance of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use.”

In the world of wheelchairs, and wheelchair accessory provision, some wheelchair manufacturers have interpreted this clause to advise prescribers that they cannot attach after-market devices (such as back supports or other postural support devices (PSDs)) to their chairs as it would be unsafe without a ‘Combination Agreement’.

It is in consideration of the potential clinical restrictions and also the potential anti-competitiveness of this practice that the BHTA has taken legal advice and issued: ‘BHTA Policy Note – After-Market Wheelchair Accessories’. The reason that there is a strong after-market of PSDs is that the clinical needs of wheelchair users are so very varied that novel solutions have often been developed to cover many of the more specialised needs where the original wheelchair and its proprietary accessories do not meet the occupant’s needs satisfactorily.

The issue is complex in that all manufacturers need to protect not only their own interests (both commercial and risk management), but also the interests of the chair occupants (safety in particular). But the level of risk can vary a great deal between different potential accessories, and different use environments. Clearly there is a big difference in the risk between applying a simple seating accessory compared with, for example, a powered add-on device that lifts the front casters, generates speeds of up to 15 km/h, and enables access to terrain previously not possible in the original manual wheelchair.

Manufacturers’ blanket restrictions are counter to fair competition and can impede optimal outcomes for end users. At a minimum, the use of third-party accessory types deemed as low risk should not be restricted without justification. On the other hand, employing a system of combination agreements or approved compatibility helps manufacturers to mitigate the risk of incidents before, rather than after they occur.  However, with the number of combinations of after-market accessories available it is not practical for all combinations to be anticipated and be covered by combination agreements.

Within the EU MDR, where a manufacturer produces an after-market accessory which they proscribe as being a medical device, it falls on that manufacturer’s risk management processes to identify circumstances where their device cannot safely be combined with another device, and provide this in their IFUs.

Another ‘grey’ area lies around modular devices. To resolve this (covering both modular devices and after-market accessories), the EU Medical Device Coordination Group has published a guidance document that defines sub-types of medical devices. One of these is “adaptable medical devices” (see MDCG 2021-3 Q & A on Custom-Made Devices, March 2021). This includes: “Note 1: Adaptable medical devices (products which fall under (a) above) are mass-produced medical devices which must be adapted, adjusted, assembled or shaped at the point of care, traditionally by a healthcare professional, in accordance with the manufacturer’s validated instructions to suit an individual patient’s specific anatomo-physiologic features prior to use. Examples of mass produced adaptable medical devices may include:

• certain spectacle frames and optical glasses (assembled together to form spectacles).
• patient fitted wheelchairs. 
• hearing aids (otoplastic and amplifier). 
• orthotic braces. 
• exo-prosthetics.“

The attached BHTA Policy Note – After-Market Wheelchair Accessories contains the legal advice provided to the BHTA on this subject, and offers guidance as to what restrictions a manufacturer can or cannot make around the combination of different manufacturers’ products. The Policy Note specifically references Wheelchairs, but the issues are as relevant for other medical device combinations such as those listed above, or, for example, combining after-market mattresses with medical bed frames.

Click here to download the After-Market Wheelchair Accessories note as a PDF.

This note summarises the key requirements for pricing practices under UK consumer law. This note has been prepared in line with relevant law and industry guidance, including but not limited to:

• Digital Markets, Competition and Consumers Act 2024 (DMCCA);
• “Guidance for Traders on Pricing Practices” [2025] produced by the Chartered Trading Standards Institute (the CTSI guidance); and
• “Price transparency” guidance 2025, produced by the Competition & Markets Authority, or CMA.

This BHTA note, produced in association with Addleshaw Goddard, is designed to help industry members ensure their pricing is clear, fair, and compliant. This note is for any member who advertises, markets, sells or otherwise promotes products to consumers at any point in a purchase process, from early-stage advertising to final purchase.

Click here to download the Pricing Practices and Price Transparency note as a PDF.