Here in the US the courts have just retracted a lower courts decision concerning "Rights to Repair" medical equipment.
This latest decision was that "Right to repair" is "not" applicable for medical equipment.
Does UK or EU laws allow "Right to Repair" of medical equipment?
Looks like the EU directive is still working its way through approval, it's here:
I can't see any exclusions, but it is for consumer products so it depends what type of equipment you're thinking of.
The UK regulations only cover a slightly bizarre collection of equipment:
CHAPTER 1 WELDING EQUIPMENT
CHAPTER 2 REFRIGERATING APPLIANCES WITH A DIRECT SALES FUNCTION
CHAPTER 3 HOUSEHOLD DISHWASHERS
CHAPTER 4 HOUSEHOLD WASHING MACHINES AND WASHER-DRYERS
CHAPTER 5 REFRIGERATING APPLIANCES
CHAPTER 6 ELECTRIC MOTORS AND VARIABLE SPEED DRIVES
CHAPTER 7 ELECTRONIC DISPLAYS
https://researchbriefings.files.parliament.uk/documents/CBP-9302/CBP-9302.pdf
Hello: Andy:
The item(s) in question here in the US was "medical equipment" which is not remotely covered by UK or EU proposed rules.
I believe the suppliers used the defense that lives could be lost if the repair work is done under the "right to repair" rules.
Many hospitals have their own internal repair shops to do "maintenance" such as removing blood products from the inside of IV pumps.*
Anything more than maintenance, it has to returned back to the manufacturer.
The other question in "right to repair", is ownership (example "lease to buy" or the old term HP) . I assume it only kicks in if the owner has FULL ownership of the product.
Am I correct?
Peter Brooks
Palm Bay
* When I used to volunteer in the local hospital one of my jobs was to move medical equipment around.
The other question in "right to repair", is ownership (example "lease to buy" or the old term HP) . I assume it only kicks in if the owner has FULL ownership of the product.
The UK legislation isn't coming at it from that angle at all, taking displays as an example it states:
15.—(1) Manufacturers, authorised representatives or importers of electronic displays must make available to professional repairers at least the following spare parts—
(a)internal power supply;
(b)connectors to connect external equipment (including cable, antenna, USB, DVD and Blu-ray);
(c)capacitors above 400 microfarads, batteries and accumulators;
(d)DVD/Blu-ray module if applicable; and
(e)hard drive or solid state drive (HD/SSD) module if applicable;
for a minimum period of seven years after placing the last unit of the model on the market.
and
16.—(1) From no later than two years after the placing on the market of the first unit of a model or of an equivalent model until the end of the period referred to in sub-paragraph (1), the manufacturer, importer or authorised representative must provide access to the appliance repair and maintenance information to professional repairers in accordance with the following provisions.
(2) The manufacturer’s, importer’s or authorised representative’s website must set out the process for professional repairers to register for access to repair and maintenance information.
(3) Before granting access to the information, manufacturer, authorised representative or importer may require the professional repairer to demonstrate that –
(a)the professional repairer has the technical competence to repair electronic displays, and complies with the Electricity at Work Regulations 1989;
(b)the professional repairer is covered by insurance for liabilities resulting from its activities.
(4) The request for registration must be accepted or refused within 5 working days from the date of the request.
(5) Once registered, a professional repairer must be given access to requested repair and maintenance information within one working day of any request. The available repair and maintenance information must include—
(a)the unequivocal appliance identification;
(b)a disassembly map or exploded view;
(c)list of necessary repair and test equipment;
(d)component and diagnosis information (such as minimum and maximum theoretical values for measurements);
(e)wiring and connection diagrams;
(f)diagnostic fault and error codes (including manufacturer-specific codes, where applicable); and
(g)data records of reported failure incidents stored on the electronic display (where applicable).
(6) Manufacturers, authorised representatives or importers may charge reasonable and proportionate fees for access to the repair and maintenance information or for receiving regular updates. A fee is reasonable if it does not discourage access by failing to take into account the extent to which the professional repairer uses the information.
So it's about making sure manufacturers don't produce equipment that can't be repaired. And very much geared to professional repairers.
Now, if you were a lease owner I agree that probably your lease would prevent you undertaking repairs yourself, which would be a contract law matter. But the "right to repair" legislation is silent. It's not actually saying you have the "right" to repair equipment, it's saying that manufacturers don't have the right to make their equipment unrepairable.
But actually (and I'll admit I'd never looked at the legislation in detail before tonight) it's pretty insubstantial, for example they only have to make spare parts "available", they don't have to be cheaper than a complete replacement new unit. So I'm really not sure how useful it is.
The EU legislation looks to be rather better (from the equipment owners point of view):
manufacturers are to provide access to spare parts, repair and maintenance information or any repair related software tools, firmware or similar auxiliary means.
Those requirements ensure the technical feasibility of repair, not only by the manufacturer, but also by other repairers. As a consequence, the repairers and, where applicable, consumers will have access to spare parts and repair-related information and tools in accordance with Union legal acts and consumers will have a wider choice of repairers or, where applicable, the possibility to repair by themselves.
Spare parts should be made available at least for the time period set out in Union legal acts.
Manufacturers that make spare parts and tools available for goods covered by legal acts listed in Annex II to this Directive, whether because of corresponding legal obligations under Union law or voluntarily, should charge a reasonable price that does not deter access to such spare parts and tools, thereby preventing repair.
To complement those measures, manufacturers should not use any contractual clauses, hardware or software techniques that impede the repair of goods for which there are repairability requirements set out in Union legal acts listed in Annex II to this Directive unless they are justified by legitimate and objective factors, including to prevent or restrict the unauthorised use of works and other subject matters protected by intellectual property rights under Union and national legal acts
But again, whether you'll be in breach of your leasing contract to repair is a completely separate matter. Again, it's stopping manufacturer's preventing repairs, not saying that anyone has a right to repair anything.
Is the case you're referring to Medical Imaging & Technology Alliance, et al. v. Library of Congress and Carla Hayden ? If so, that's another complication again, as I understand it that's not really about the right to repair medical equipment - although that's the story that made the headlines. It's about to the right to gain access (or, from the other side, the right to prevent access) during the repair to copyrighted software (or indeed any IP) which could then be downloaded and cloned or reverse engineered. The UK and (proposed) EU regulations appear to avoid this by allowing the manufacturers to permit modular repairs, which could therefore be "closed and locked" modules. (Oddly, only a few days ago I was reading about a modular music synthesiser design sold through UK hobby magazines in the 1970s, where the modules were (presumably) discrete components but potted. So they couldn't be reverse engineered. An updated version of that would be fine under the regulations.) But that is a very thorny area. Also note the clause in the UK regulations which is another way around this, by saying that the manufacturer can manage a register of repairers, i.e. they only approve repairers where they have a contract protecting their IP.
I'm very glad that the valve amp I've just (very successfully) repaired was based on a 1950s design where it was just a matter of a quick Google to find the circuit diagram, that was much easier! For the two manufacturers I worked at for the longest periods of my career, at one we actually provided all the repair information (along with full circuit diagrams) along with each product, we assumed that purchasers would be likely to have competent in house maintainers. That made life very much easier. (I left 30 years ago but still occasionally get calls for help from owners of the equipment, which I'm always delighted to help with.) At the second manufacturer we made (and they still make) safety critical systems, and that was very definitely "return to base" repairs. Not for any financial reason, but because we couldn't risk incorrect repairs resulting in a fatality. If the UK legislation ever does widen out it'll be interesting to see what happens there, I suspect there would be clauses that for safety critical systems (so potentially including medical systems) that the manufacturer could limit the right to repair to strictly approved bodies. Wearing my day job hat as an ISA I'm always pointing out to clients that they do hold a level of responsibility for their equipment once it's left the factory gate, they do need to consider the full lifecycle.
Important to remember that the EU and UK "right to repair" legislation is about environmental protection (i.e. reducing waste), not civil liberties, I've no idea if the US legislation is coming from the same point of view. So "right" is really the wrong word to use, the EU legislation "promoting the repair of goods" is much better wording.
Back to the US case, I did lead the development of one product where there was one very critical bit of IP we would not want customers to access, for both financial and functional safety reasons. But if we had been covered by any sort of "right to repair" we would simply have made that circuit board available as a single component. However I suspect the situation in the US case was a much more complex system, which did require software access to "repair".
Hello Andy:
Boy you wrote such a lot that I am going to split my response into sections.
At one time I was involved in the creation of a industry specification for drop testing cellphones- so many feet over bare concrete floor.without damaging the end item. This forced companies to glue critical sub-components inside.
Sometimes they were forced to use special "silver based thermal glues to provide adequate heat sinking for the high wattage IC's. Think of the heat sinking problem on the early Xbox and PS3 systems.
From a sub-component point of view many orders for the product were "one of a kind" special orders - never to be made again.or were specially selected/screened, while carrying a regular part number, with final assembly taking place at a unique location maybe in a certain factory located in China or Malaysia.
Then there is the hidden backdoor situation.
It is a configuration control nightmare.
Peter Brooks
Palm Bay
It is a configuration control nightmare.
Oh absolutely. I can very much see this from both sides. It really annoys my how much 99% serviceable engineering goes into landfill for want of a single component (hence volunteering at a Repair Cafe), but equally having worked for (or these days with) manufacturers for most of my career it is, as you say, a configuration nightmare - you want to improve your products, you have to cope with component obsolescence, but as you do the ability to provide spares gets more and more complex. Now, in the two main manufacturers I worked for we did have a strong culture of designing for modularity so that if you did change part of the design it was, as far as reasonably possible, practical to make it backwards compatible (so spare parts for "old" versions weren't a problem, you could fit the later part). But that was in expensive equipment where we could afford slightly complex engineering to do this where needed. For "designed to a price" consumer products I can see it would be a lot more complicated.
And even with the best will in the world, in both companies we had to do a lot of educating to service teams as to what was compatible with what, sometimes 100% compatibility simply couldn't be achieved.
Of course a good start is to design and manufacture things so they don't break in the first place as far as you can...or so they don't simply become unusable, what I get really cross about is having to dispose of an otherwise perfectly functional mobile phone (for example) just because it can't run the "latest app" - I had to replace my last iPhone (yes I am naming and shaming Apple!) because I couldn't install a simple app to pay to park my car! Which is ridiculous, it was a perfectly functional, and (for someone born in 1960) very powerful "pocket computer" which was perfectly capable of handling a £1.50 transaction...whinge over.
We're about to take you to the IET registration website. Don't worry though, you'll be sent straight back to the community after completing the registration.
Continue to the IET registration site
