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In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the agency that regulates medical devices and in vitro diagnostics, as well as clinical investigations into those devices.
The MHRA has a guidance document for MedTech companies, Clinical investigations of medical devices - guidance for manufacturers, that provides information on everything from the decision to undertake a clinical study, to the timeline for receiving approval for your application.
If you plan on carrying out a clinical investigation in the UK, this document will be your go-to for understanding the requirements and regulations you’ll need to comply with.
So in this article, I’ll give you a primer on what you can expect to find in the guidance and some of the most important points you’ll want to consider as you read through it.
One of the first things you’ll notice as you read through the guidance is that Northern Ireland is a special case in regards to clinical investigations.
As the MHRA guidance document notes:
The Northern Ireland Protocol requires Northern Ireland to continue to align with EU rules for devices after 1 January 2021… This means that clinical investigations being conducted in Northern Ireland must meet the requirements of the EU MDR and be submitted to MHRA in accordance with these regulations.
In other words, there are three scenarios here:
Finally, a note on some of the acronyms you’ll see in the guidance:
One of the most important points to keep in mind here is that if your device is not already UKCA/CE marked, you must notify MHRA of your planned clinical investigation.
Investigations into non-UKCA/CE marked devices must be designed to:
This section of the guidance deals with the initial question of whether or not your device requires a clinical investigation.
These include asking questions like:
The guidance also includes a section on “special considerations”, one or more of which could apply to your device:
This section of the guidance includes a number of considerations to take into account while planning your clinical study.
I’d recommend reading through them all carefully, but one of the most important points here is the post-market clinical follow-up (PMCF). Both UK MDR 2002 and EU MDR require manufacturers to actively update their clinical evaluation with the data they obtain from post-market surveillance.
If you don’t believe a PMCF is required in your case, you’ll need to justify and document that decision. However, there are numerous situations listed in the guidance which will require you to undertake a PMCF:
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Stephanie Hinton is a Clinical Medical Device Guru with over a decade of combined experience working in human subjects research. Her expertise includes recruitment strategy, protocol development, IRB submissions and amendments, preparing for NIH grant applications, as well as coordinating and planning for DSMB...