![MHRA guidance document on clinical investigations in UK]()
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.
BONUS RESOURCE: Click here to download our 15-in-1 clinical investigations content bundle to help you run studies and collect clinical data more efficiently.
How has the guidance been revised for Northern Ireland?
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:
- You have a study site(s) in Northern Ireland. In this case, your submission to the MHRA must be in line with the requirements of EU MDR.
- You have a study site(s) in Northern Ireland and Great Britain (England, Wales, and Scotland). In this case, you must still be in line with the requirements of EU MDR. By satisfying the requirements of EU MDR, the MHRA will consider you to have satisfied the requirements of UK MDR 2002.
You do not have study sites in Northern Ireland. In this case, your clinical investigation needs to meet the requirements of UK MDR 2002.
If you do plan to have study sites in Northern Ireland, pay close attention to the boxes in guidance that provide information on the Northern Ireland-specific requirements. They look like this:
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Finally, a note on some of the acronyms you’ll see in the guidance:
- UKCA (UK Conformity Assessed) marking is used for products placed on the market in Great Britain (England, Wales, and Scotland).
- UKNI marking is used for products placed on the market in Northern Ireland.
- CE marking is used for products placed on the market in the European Union.
It’s important to point out that Great Britain intends to extend recognition of CE marking for goods placed on the market in the UK indefinitely. That’s why you’ll see UKCA/CE and UKNI/CE used in the guidance document. It’s recognizing that CE marked devices may also be placed on the market in the UK.
Clinical investigation in the UK: general considerations
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:
- verify that under normal conditions of use the performance characteristics of the device are those intended by the manufacturer; and
- determine any undesirable side effects under normal conditions of use and assess whether these constitute risks when weighed against the intended performance of the device.
If the purpose of your clinical investigation is anything other than demonstrating performance and safety (e.g. user handling or preference studies) then the investigation should not be carried out on a non-UKCA/CE marked device.
In other words, you’ll need to demonstrate the performance and safety of your device in order to get UKCA/CE marked. Other types of studies have to wait until you’ve demonstrated the device adequately complies with the general safety and performance requirements in Annex I of EU MDR.
The guidance writers conclude this section by pointing to BS EN ISO 14155:2020, saying, “This is not a designated standard, however, we would expect manufacturers to adhere to this ISO standard as it is deemed to be best practice.”
Is a clinical investigation required: the practical decisions
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:
- What are the essential requirements/general safety and performance requirements relevant to the device in question with which compliance must be demonstrated?
- What data is required in order to demonstrate this compliance?
- What testing is necessary to produce this data e.g. bench testing, animal testing?
- Is clinical data required to demonstrate compliance? If so, does the clinical data already exist on the device in question (published or unpublished) or by analogy with published data generated in respect of an equivalent device?
The guidance also includes a section on “special considerations”, one or more of which could apply to your device:
- Change in intended use/performance claims of a device
- Comparative studies
- Prototype devices
- Clinical investigations also submitted to the FDA or other regulatory authorities
- In-house manufactured medical devices
- Off-label use
- Research tools
- Humanitarian use of non-UKCA/CE UKNI/CE marked devices
Clinical investigations — things to consider
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:
- Innovation, where the design of the device, the material, the principles of operation, the technology or the medical indication is new
- Severity of the disease
- Sensitive target population
- Risky anatomical location
- Well-known risks associated with a similar marketed device
- Well-known risks identified from the literature
- Identification of an acceptable risk during pre-market clinical evaluation, which should be monitored in a longer term and/or through a larger population
- Identification of emerging risks in similar products
- Obvious discrepancy between the pre-market follow-up windows and the expected life of the product
BONUS RESOURCE: Click here to download our 15-in-1 clinical investigations content bundle to help you run studies and collect clinical data more efficiently.
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