If your device is already CE marked, you have probably read MDCG 2020-6 (published in April 2020), which provides guidance on the clinical evidence needed for legacy products. You would have also developed a Clinical Evaluation Report (CER) for your devices and carried out post-market surveillance (PMS), but where should you get your clinical data from?
Yet again, footnotes hidden away in MDCG do provide some helpful information regarding post-market sources of clinical data and tells us that independent clinical studies using the device are to be included. Now, I know what you are thinking; ‘Well that’s stating the obvious!’
Yes – I guess it is. But what IS really interesting is that footnote 37 states;
“Including for example devices used during clinical trials of pharmaceutical substances, or accessories to other medical devices, where the device is clearly identified”
This means that there is a potential risk, that you could miss out on essential keywords during your literature searches, if you first don’t investigate what other devices or pharmaceuticals, your device is used in conjunction with. If your device’s name is not the focus of the article, it could still be mentioned within the body of the paper concerned, but the search wouldn’t find it. So, there could be more quality data out there, which you then don’t use as evidence within your own PMS.
For example: for a widely used device like a syringe (which shows 20,006 results via the PubMed search engine), you could add keywords on the pharmaceuticals used (narrowing it to 1,201 results) or other devices it’s used with; such as to give intravenous medication through a butterfly needle (focusing it further to 39 relevant results).
This is why it is so important to have a clear literature search strategy and a well-thought-out list of keywords; so that you can include every piece of important clinical data within your CER and PMS.
Of course, this will be more relevant for devices used in certain therapeutic areas. But it’s well worth pausing to take into account the wider usage and complimentary products used in combination with your device, to consider all possibilities; especially if you have struggled to obtain enough worthwhile data on your specific device in the past.
Article written by Medilink Midlands member IMed Consultancy. For further information please email email@example.com