This post introduces a new collection of EC and EU papers concerning the regulation of medical devices.
In the course of searching for sources which might illuminate the history of medical device regulation in Europe, I visited the website for the Historical Archives of the European Union. However, I could only access a very small number of relevant files due to the 30 year rule. This states that Commission documents will only be transferred to the archive after 30 years. One can, nevertheless, write to the Commission directly and ask for anything they might be able to share. Which I did, and received a great deal of very valuable assistance from their archivists. The result was a new collection of papers related to the development of three pieces of EC/EU legislation concerning medical devices. I have prepared a guide to these documents which can be accessed here.
The guide gives important information about each document, and also a short description concerning their contents. It also includes hyperlinks to each document, which I am making accessible through my Google drive. The links are open to everyone and should not require you to log in anywhere in order to access them.
By way of introducing this new collection, I thought I would write about a couple of the themes I noticed after reading these files.
Devices and Medicines
Throughout these proceedings delegations often wanted to emphasise a distinction between existing European legislation governing pharmaceuticals and medical products, as opposed to devices. I was primed for this kind of discussion thanks to my earlier work on the pre-history of medical device regulation in the UK and Ireland. There, while researching the creation of The Medicines Act 1968 in the UK, I learnt that it was initially intended to include devices, though these were eventually excluded from the Act’s scope. My working hypothesis is that this exclusion arose at least in part because of how much difficulty legislators faced distinguishing between pharma and non-pharma, making the question of devices a bridge too far.
It was, therefore, interesting to see how often the UK delegation brought up the worry about distinguishing between medical products and medical devices during the development of these pieces of legislation. For examples see st05887.ed89, st09899.en89, and st05998.en92. Likewise, see the interesting discussion of whether human tissues should be considered more like products or devices, as in st04325.en96. Definitional problems are unavoidable in the making of legislation, given that the world is not easily carved up, and different people will see categories and their distinctions differently. But aside from this generic point, the power dynamics between the pharmaceutical industry, on the one hand, and the medical devices industry, on the other, are worthy of much closer attention.
Other scholars have already pointed out that the UK, France, and Germany were the main players when it came to determining the shape of EC/EU medical devices legislation. And to a large extent these documents confirm that point. Nevertheless, they also reveal some further interesting episodes. For instance, in order to try and influence the range of devices incorporated into the scope of Class I devices (concerning what would eventually become Directive 93/42/EEC), the Irish delegation used the fact that it basically had no existing regulatory apparatus in place as a reason to keep that scope narrow. As they wrote in a note to the Working Party (st10136.en92), “It is fair to say that Ireland will be starting its Medical Device Vigilance System from scratch.”
The question of how medical devices were governed prior to this time, and the kinds of informal vigilance mechanisms that may have been in place, would make for an interesting future research project. Another interesting suggestion was supplied by the Dutch delegation, when it came to this same piece of legislation. They were, however, interested in increasing specificity of context when it came to a manufacturer’s stated expected performance levels for their devices. The performance of a device in the home, for instance, might be expected to be different if located in a hospital, etc. In st08171.en92 one can read their overall concern, and learn a little about a scheme carried out in the Netherlands regarding wheelchair performance, the thrust of which they felt could inform device assessment more generally. While the Netherlands and Ireland do not loom large in these proceedings, thanks to these documents we can at least gain some insight into their own more immediate concerns and contributions.
Someone with a more fine-grained appreciation for the development of legislation will no doubt be able to draw much more interesting lessons from these documents than I can. The draft Articles and Annexes that we can watch grow, receive criticism, and go through redrafting must surely tell a story about bureaucratic preferences, changing conventions, the influence of stakeholders, etc. These documents are, however, relatively sanitised, and it would require more general access to the relevant archive materials to get an insight into the interests motivating discussions. Even learning which people were involved is not a straightforward task, as delegates are rarely (if ever) referred to directly in these files. I hope that this collection, nevertheless, proves useful to some, and inspires future work in others.
Written by: Dominic J. Berry.
Funding: Work on this was generously supported by a Wellcome Trust Investigator Award in Humanities and Social Sciences 2019-2024 (Grant No: 212507/Z/18/Z).