Please find below the recently updated BAHT MHRA / Medical Device guidance.
The Medical and Healthcare products Regulatory Agency (MHRA) is the Government organisation that monitors and regulates medicines, medical devices and blood components in the UK. MHRA are also responsible for Medical Device Regulations (MDR) which covers off-the-shelf devices and thermoplastic custom moulded splints that Hand Therapists provide for a medical purpose.
The government has laid legislation to continue recognition of current EU requirements, including the CE marking (Conformité Européene, or European Conformity marking). The legislation will apply indefinitely for a range of product regulations. This means businesses will have the flexibility to use either the UKCA (UK Conformity Assessed) or CE marking to sell products in England, Scotland and Wales (Northern Ireland is not yet included). This legislation can be found in The Product Safety and Metrology etc. (Amendment) Regulations 2024 here https://www.legislation.gov.uk/ukdsi/2024/9780348260311/contents
Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, see https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#NI
The government has now put in place legislation to extend acceptance of CE marked devices in Great Britain. It has introduced legislation which provides that CE marked medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and can be placed on the Great Britain market up until the 30 June 2030. For more detail of these transitional arrangements see the implementation update on work towards a strengthened future medical devices regime visit https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
Post-Brexit changes to Medical Device Regulations (MDR) previously led to uncertainty amongst hand therapists and BAHT have provided the following guidance and reassurance to hand therapists working in the NHS.
Pre-Fabricated (aka off-the-shelf) devices / splints
Prefabricated / off the shelf splints need to display a CE / UKCA mark. Manufacturers of prefabricated devices need to meet the requirements of the UK Medical Device Regulations, 2002.
A therapist using a CE/UKCA marked splint and adjusting to fit for an individual patient holds no additional regulatory requirements as long as the device is used according to manufacturer instruction and intention.
Pressure Garments
When we write a prescription for custom made pressure garments, the company producing the garment is the legal manufacturer. The legal manufacturer needs to meet the regulatory requirements for custom made medical devices. They will need to register with MHRA if they have not already done so and supply the relevant declarations. In-house manufactured pressure garments would fall under custom made device advice below.
Custom-made Devices / Splints
Splints / devices manufactured by therapists in-house and provided to patients within your Trust, are subject to in house exemption. Splints must not be put onto the market or put into service outside your Trust. Any prefabricated components should be CE/UKCA marked. Thermoplastics supplied as raw materials (e.g. as rolls or sheets of material) from which to manufacture the splints are not regarded as medical devices in their own right.
Documentation
MDR recommend that medical professionals providing medical devices should record the following information for each product they prescribe to a patient (indicated in bold
font). This information should enable the repeatable provision and tracking of the product. Additional guidance from BAHT for each MDR recommendation is provided in italics.
The written record / prescription should detail:
1. Data allowing identification of the device in question, i.e. description, serial number, order number, generic name.
· additional information: record the accepted generic name of the splint and detail of material used. Where relevant, the serial / batch number of the splint material should be documented as this allows exact tracing back to the product.
2. A statement that the device is intended for exclusive use by a particular patient, together with the name of the patient (this may be an identification number if patient confidentiality needs to be maintained, provided it can be traced through records to the named patient)
· additional information: the patient record should document that the device is for the exclusive use of that particular patient. This should be explicit on written patient information provided with every device.
3. The name of the qualified person, medical practitioner or other authorised person who made out the prescription and, where applicable, their place of work
· additional information: the device ‘prescription’ will be recorded in the patient therapy / medical notes and entry dated and signed off by the prescriber.
4. The particular features of the device as specified in the relevant prescription, i.e., the written prescription with its special features extracted to define the particular device.
· additional information: this should include detail such as position of limb / joint(s) within the splint, whether the inserts (metal or plastic) from off the shelf splints have been adjusted & if so how, or removed.
· from this information a medical professional should be able to repeat the prescription of the product from the detail documented in the patient record.
5. A statement that the device in question conforms to all the relevant essential requirements and, where it does not, the grounds for believing it is safe for use.
· additional information: this could be a department statement that the off the shelf & thermoplastic splints provided conform to essential requirements i.e. CE/UKCA marked and used in line with manufacturer recommendations. This can be added to the patient information leaflet which is issued with the device.
6. The name and address of the manufacturer
· additional information: the distributor's company name is sufficient to hold within the therapy department records.
Examples:
1. A volar wrist extension / cock-up splint using 3.2mm xxx material manufactured and fitted for exclusive use of Joe Bloggs. Moulded over cotton stockinette with additional provided. Wrist extension of 30 degrees achieved and digits unrestricted. Splint secured with 3x hook and loop / Velcro straps and additional stockinette provided for use under the splint . As prescribed by XX therapist (signed and dated). A patient information leaflet should be provided with every splint issued.
2. Elastic wrist brace medium left (brand name) fitted for exclusive use of Josie Bloggs. Volar extension bar adjusted to increase wrist extension to 30 degrees as prescribed by XX therapist (signed and dated). A patient information leaflet advising that off the shelf splints meet CE / UKCA safety requirements.
Or consider using a template:
This splint has been provided for exclusive use of (patient name)
Splint Name Hand Resting Splint
Material 3.2mm XXX
Position Volar hand and forearm based. Wrist 20 ext, MCP’s 50 flex, IP’s -10 ext
Fastening 3 x Hook and Loop Straps
Wearing Instructions Overnight and daytime rest periods
Additional
Information Stockinette provided for use with splint Patient aware to check skin for pressure areas Written information leaflet provided
For further information please refer to the links below: https://www.gov.uk/government/publications/custom-made-medical-devices/custom-made-devices-in-great-britain
https://www.gov.uk/government/publications/in-house-manufacture-of-medical-devices/in-house-manufacture-of-medical-devices
The information provided is based on our best judgement of the information available and subject to change. This is not a definitive statement of law and we advise you to seek the views of your own professional advisors.