In February 2023, we posted an explanation of the EU Medical Device Regulation, which, to the best of our knowledge, still applies to the UK post-Brexit:
We have also run posts on the vaginal mesh saga, the weight loss balloon and other deadly devices.
One of the key weaknesses of the current system is the assumption that a new device is equivalent to an ancestor device, which could even be a legacy device no longer in use. Proof (and often self-certified proof) of equivalence will get your device through the regulatory process and get a CE mark. You can then market your device within the indications listed in your certificate.
The concept of equivalence holds for any device, from toys to medical devices.
As we have explained, the regulatory process is convoluted, but it does not sufficiently address the significant issue of medical devices being used on human beings, not on toys, widgets, or vending machines.
Our mesh work was cited in a recent paper on the streamlining of regulation which is why we got an automated message drawing our attention to the paper by Sündermann and colleagues.
The abstract which gives you the summary of the article:
The paper is full of regulatory and IT jargon. Still, the bottom line is that big data methods can be used to assess the similarity of new devices to existing licensed devices, allowing the speeding up of registration processes.
Similarity is not defined and is assumed to be the same as equivalence. Computerised algorithms would automatically assess similarity: “distributional semantics to generate text similarities.” The example of registering and using the mesh and other deadly devices is cited but brushed aside as “not part of the paper.”
In an ideal system, streamlining device registration through the analysis of structural similarities may work (although some of our readers may have other views on the issue).
However, automated systems that do not correctly assess the risks and benefits of device use in humans are on the fast track to further disasters, with thousands more women being irreversibly harmed.
This post was written by two old geezers who are not equivalent.
Readings
Medical device similarity analysis: a promising approach to medical device equivalence regulation. Expert Review of Medical Devices, 1–13. https://doi.org/10.1080/17434440.2024.2402027
The cited paper is a classic example of naive writing about algorithms. Leaving aside all the questions about the nature of rules and the social contexts that shape their interpretation and use, how long would it be before device manufacturers were gaming the system in their use of language to describe their products? This is a proposal to assess the similarity of texts not of devices...
In the aviation and military world “similar” items to already certified items still need to be certified (or qualified in their jargon). Such qualification can be by test, analysis (e.g. simulation), read across to previously qualified parts, etc. This proposal seems to be suggesting adopting the read across approach but this should only be used if the changes are relatively minor. Creating a new item using different materials, different functionality and different reliability and maintenance regimes do not count. As RD has already said, manufacturers will start gaming the system to get their products through. Which is precisely what they do now when trying to get aerospace parts qualified - they try to qualify by read across because it is the quickest and cheapest method. The only thing keeping them on track is the regulatory authorities but I have little confidence our health regulators are anywhere near the level of competence, integrity and professionalism of our air safety regulators.