Medical Device Registration

Several years ago, at the start of the Open Voice Factory project, it became clear that we'd need to register the Open Voice Factory, or some part of it, as a medical device. It was publicised to, in the words of the relevant european directive 'mitigate handicap', and so it needed to be registered.

There is no moral way around that.

It also became clear that there were almost NO other open source medical devices. Or at least, none that could be found.

So we start from the begining. in the UK medical devices should be registrered with the MHRA before they can be sold (or 'made availible' according to the EU directive - this includes letting them be downloaded). We understand that we have to submit a technical file to the MHRA before we can properly release the Open Voice Factory.

This is the letter we sent to the MRHA originally: MRHA letter.

We've consulted with a developer who has experience taking software through medical device registration and who already has some familiarity with our work. Here's the understanding we now have: To register as a medical device you must produce a technical file. Part of that technical file is about the organisation itself - how do you decide what features to add, how do you assess risk and so on. To show this, we need to have a set of policies that cover the developement of the device, and, we need to be able to show that we are following them. So the process looks like this:

• Write and approve policies
• Wait (while writing the rest of the technical file)
• Check that we've been following our own policies (with evidence)
• Add the evidence to the technical file and submitt.

Our consulting developer has recommended the following five policies (based on his experience, this isn't a standard set):

• Development,
• Document Management,
• Risk Management,
• Continuous Improvement
• Post Market Surveillance

(Drafts of these policies can be seen here

Now, the medical device rules say that you have to have a 'state of the art' process. It appears that you can either prove your own process to be state of the art, or follow one of the International Standards, on the basis that it's understand that these standards establish the state of the art. The relevent standards here appear to be:

• IEC 82304, 6
• ICE 2304
• ISO 14971
• Possibly ISO 13485

...and we have purchased these.

We're now at the point of creating a technical file, our understanding is that part of the technical file is about the organisation itself – how do you decide what features to add, how do you assess risk and so on. To show this, we need to have a set of policies that cover the developement of the device, and, we need to be able to show that we are following them. So the process looks like this:

• Write and approve policies
• Wait (while writing the rest of the technical file)
• Check that we’ve been following our own policies (with evidence)
• Add the evidence to the technical file and submit.

which in summary is "The policies and the evidence that we are following them" but which actually contains a few more bits. This repository is being built up to contain the full submission. There is more information (and links to the threads for each individual element here)

Background

(from the perspective of a UK organisation)

There is some government guidence here. More here. In particular:

It is a requirement of the UK Medical Device Regulations that you inform MHRA, the UK competent authority, when you first place certain devices on the market

To register a medical device with the MHRA you must first register on their website. We've explored that option to check at what point there is a problem (or if there are particular formats they want for the technical file), and you can find information about how far we've got with that here