Regulators are not there to be feared. Speaking to MHRA was one of the most useful Automedi positioning exercises.
You cannot touch upon UK healthcare product safety without considering several relevant bodies. The two most essential being:
Medicine and Healthcare products Regulatory Agency (MGRA)
Health and Safety Executive
Also, having a good lay-person's understanding of product safety law (General Product Safety Regulations) is a great advantage.
To that end, we always aimed to seek the regulators' advice in the creation of our catalogues and on-boarding processes. Especially how the law applies in a case where the manufacturing of a product crosses responsibility boundaries. Each such case, an Automedi scenario medical device regulations could not have foreseen.
Many conversations took weeks to organise, were quite chaotic, but provided extremely valuable takeaways.
Why In-house Manufacturing?
Determining whether a product is a "device" is an essential first step for the regulatory and compliance regimen granting a CE mark and allows introduction into the health sector. However, not everything is a device.
The Automedi appliance is not itself designed for the protection of the patient. The meeting with the MHRA seemed unanimous on this. However, what the products Automedi created, could potentially be devices. It is those that much of our energy has been focused on since.
This is where the in-house manufacturing regulations come into play.
These regulations don’t apply if your device is only being used for patients within the institute it was made, even if the product is made in one part of a healthcare establishment. For example, an NHS trust laboratory and moved to another part of the hospital, as this means you are not placing it on the market.
This decision led to our choice to provide services to hospitals, CCGs and care partnerships on a per establishment basis, using in-house teams for control of the machines and checking the manufacture, much the same as it would for prosthetics or implants. Allowing teams to create essential protective equipment, faster.
Current COVID-19 Climate. Exemptions
Several weeks ago, we attempted to speak to the MHRA to determine the regulations surrounding Automedi. While I was obviously very clear on the need for a CE markings from another life, what we didn't know was whether a CE mark would be required for Automedi "the appliance"; "the catalogue" as a whole or "products" within it. Our expectation was the appliance would fall outside scope, because by itself, it isn't to protect the patient. The whole catalogue probably wouldn't be in scope, but the individual printable items within it, probably would, depending on what it is.
Yet, for the COVID-19 effort, the MHRA created an exemption regime to allow providers to create and donate medical equipment, which was still safe and led to community efforts around face visors and ventilators. This will come to an end and products launched during this period must have a verified road-map to certification. This will certainly be a requirement to launch products on the Automedi platform.
Epilogue
When this project began, I was under no illusions we had to tackle health and safety from the very beginning of the project and treat it like a first class citizen. One of the first items in the first shipment of equipment and parts, was air quality metres and automatic fire suppression. The list of experiments we needed to run very deliberately included:
Appliance behaviour
Material science
Fumes, filters and toxicity
Energy emissions
Misuse research
Our research expected most of these to be unsurprising, which they were. Yet, as someone who has never relied on other people's research unless from a recognised university or scientific establishment, peer reviewed and in a journal. Especially in an era where everyone considers themselves "expert". Being useful with mathematics and statistics, especially in research form, I couldn't consider building the product without a strong understanding of health and safety implications and especially how it affects the context in which those devices operate.
I have never been more glad to have had a meeting with a regulator. If only to confirm the sanity.
Want to know more? Examine Automedi's purpose and download the brochure for more info.