There has been a lot of discussion surrounding the focus of treatment within primary care.  The NHS published guidance in August 2023 for integrating point of care IVD’s (NHS England » Integrating in vitro point of care diagnostics: guidance for urgent community response and virtual ward services).  The Labour Party’s recent manifesto for the 2024 General Election stated that “Labour’s reforms will shift our NHS away from a model geared towards late diagnosis and treatment, to a model where more services are delivered in local communities” and “The National Health Service needs to move to a Neighbourhood Health Service, with more care delivered in local communities to spot problems earlier. To achieve this, we must over time shift resources to primary care and community services.”  (Change Labour Party Manifesto 2024).  Whilst this is good news for patients, it is not as simple as changing the location of the testing – there will be implications for the IVD industry in order to meet these proposals.

The In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’) defines a “device for near-patient testing” as “any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.”

During Design & Development, IVD manufacturers have to determine the use environment and end users within their intended purpose.  It is then their responsibility to demonstrate that the device is safe and effective when used in these environments by these intended end users and therefore there will be a number of additional requirements that need to be considered for devices intended for near-patient testing.

Performance Requirements:

The performance testing conducted will need to demonstrate that effective and reliable testing outside of the traditional controlled laboratory environments.  Considerations such as the following will need to be considered:

• Use Environment Testing:

Annex I section 9.4 states “The characteristics and performances of the device shall be specifically checked in the event that they may be affected when the device is used for the intended use under normal conditions:

(b) for devices for near-patient testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances).”

Testing of the device will therefore need to be conducted in the intended use environments. Manufacturers will need to show that the test can be used reliably in the environments that they indicate that the test can be used in. This could be, for example, doctor’s surgeries, A&E departments, patient’s homes or in ambulances.  Any conditions specific for these environments would need to be considered e.g. vibrations or temperature fluctuations for devices intended to be used on an ambulance.

• Usability Studies:

Annex I section 19.1 states that “Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user’s technique and environment. The information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result provided by the device and to avoid misleading information. In the case of near-patient testing, the information and the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience required by the user.

It is important for manufacturers to have designed their device in such a way as to ensure that the intended end users can successfully use the device.  Therefore it is vital that manufacturers conduct usability studies with their target end users who are often not laboratory trained personnel.  This can then be used to demonstrate that consistent results can be obtained by these target end users, determine if the instructions provided with the device are adequate and help to identify if any training is required for the end users before the device can be used reliably.

Labelling Requirements:

The IVDR has also introduced specific labelling requirements for NPT (near patient testing) devices, including:

• Devices labelled as Near-Patient Testing: The device label must indicate that the device is for near-patient testing.  Although there are currently no symbols for this within ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer, MedTech Europe has provided some suggested symbols that can be used to indicate near-patient testing (New IVD symbols for compliance with the IVDR – MedTech Europe).
• Individual Instructions for Use: Each individual device must be accompanied by its own instructions for use (IFU).  For devices for professional use within a laboratory setting, if multiple devices were supplied then a single copy of the IFU could be provided if agreed by the purchaser.  This is not allowed for devices intended for near-patient testing.
• Paper-Based Instructions: According to Annex I 20.1(f) of the IVDR, the instructions for use must be provided in a physical paper format for near-patient tests, and, unlike laboratory based professional use devices, cannot be provided in electronic format.
• Language Requirements: The languages that the Member States require for the device label and instructions for use for near-patient testing may be different to those for professional use only tests.  This may add more translation costs on to manufacturers to access different markets.

The labelling provided must be appropriate to the device, its intended use, and the technical knowledge, experience, education, or training of the intended users.  This will need to be considered by manufacturers when designing the labelling and tested during usability studies.

Notified Body Assessment

Whilst devices for near-patient testing are classified in their own right according to Annex VIII rule 4(b), the notified body assessment is slightly different.  For Class B & Class C devices, the technical documentation of all devices for near-patient testing has to be assessed rather than the notified bodies sampling one technical file per generic device group or device category. Where a manufacturer has a number of devices for near-patient testing the increase of upfront cost to have their devices assessed will need to be considered.

Final thoughts

Whilst near-patient testing seems like a real win for patients and the direction of travel that the diagnostic industry is heading, this does provide some challenges for manufacturers.  The additional burden to demonstrate that the device is effective and reliable when used outside of a laboratory setting and the potential increased upfront costs of conformity assessment is something that needs to be considered before being able to place the device on the market.  For Great Britain, although the UK MDR 2002 does not specifically call out devices for near-patient testing currently, the indications from the MHRA on the future regulations is that it will be similar to the IVD Regulation with the new Essential Requirements being based on the General Safety & Performance Requirements.  This is likely therefore to mean that the additional requirements for these types of devices will also be required here.  However, if done correctly, near-patient testing will enable quicker diagnoses for patients and hopefully therefore better patient outcomes, which is ultimately what the IVD industry wants to support.

If you’d like to discuss near-patient testing or any of the compliance services that come along with it, from design and development to regulatory services, you can speak to us by dropping an email to [email protected] or book time with us via this link for when best suits you