Custom-made devices in Great Britain

Question 1

Custom-made devices in  Great Britain

Accepted Answer

This guidance applies to medical devices placed on the market in Great Britain (England, Wales and Scotland). Medical device regulation in Great Britain is defined by the UK Medical Devices Regulations 2002 as they apply in Great Britain (SI 2002 No 618, as amended) (UK MDR 2002).

These guidelines aim to help manufacturers understand compliance requirements for the manufacture of custom-made active implantable medical device or custom-made medical device.

As defined by UK MDR 2002 5 (1), a custom-made device is:

manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other person authorised to write such a prescription by virtue of their professional qualification, which gives under their responsibility, specific characteristics as to its design
intended for the sole use of a particular patient, but does not include a mass-produced product which comprises a medical device and medicinal product forming a single integral product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user.

As far as active implantable medical devices are concerned the requirement is that only a medical specialist may write the prescription. This is defined in the Regulations UK MDR 2002 as ‘a registered medical practitioner as, or is undergoing training intended to lead to qualifications, a specialist’.

Examples of professional users: Ophthalmologist, optometrist, orbital prosthetist, ocularist, audiology technicians, orthotist, dentist, hearing aid dispenser, orthopaedic shoe fitter.

A written prescription may take the form of a letter from a qualified person or a moulded impression of the shape of the required device together with the order specifying customer details, and a request to ‘make as pattern’.

It is the qualified person who is responsible for specifying the particular design characteristics of the product.

The manufacturer of a custom-made device must meet the particular requirements of the UK MDR 2002 which relate to custom-made devices. These requirements are not intended to interfere in any way with the professional and clinical responsibilities of the prescriber. The activities carried out by the healthcare professional in supplying or fitting a custom-made device (e.g. preparation, impression taking, prescribing, final fitting and any adaptation), are not considered to fall within the scope of the UK MDR 2002.

Mass-produced devices, which need to be adapted to meet the specific requirements of a healthcare professional (and which are supplied for the sole use of a particular patient), are not considered to be custom-made devices (e.g. contact lenses and stock footwear).

Question 2

See MHRA’s Guidance for manufacturers of prosthetic and orthotic devices.

Question 3

Conformity assessment requirements

Accepted Answer

Manufacturers of custom-made devices must follow the requirements specified in the relevant Annexes which apply to them:

for medical devices: Part II of the UK MDR 2002 (as modified by Part II of Schedule 2A)
for active implantable medical devices: Part III of the UK MDR 2002 (as modified by Part I of Schedule 2A)

Although a custom-made device is manufactured to the prescribed requirements of the healthcare professional, if it is to be fit for its intended purpose, it must meet all the relevant essential requirements (Annex I [as modified by Schedule 2A for the relevant Part of the UK MDR 2002]). The manufacturer should consider whether the following are relevant:

chemical, physical and biological properties of the device
infection and microbial contamination
construction and environmental properties
protection against radiation
requirements for medical devices connected to or equipped with an energy source
information supplied by the manufacturer, including labels

As a minimum requirement the labels on a custom-made device must include:

The manufacturer must also review the requirements regarding other information that is to be supplied with the device and determine what is appropriate for their products.

Question 4

UKCA marking

Accepted Answer

Custom-made devices and custom-made active implantable medical devices are not required to be UKCA marked when they are first placed on the market and/or put into service. However, they must meet the relevant provisions of the UK MDR 2002 that apply to them. In addition, manufacturers of custom-made devices do not require the intervention of a UK approved body.

Question 5

Statement concerning custom-made devices

Accepted Answer

The manufacturer of a custom-made device must comply with the relevant Annex of the UK MDR 2002 (as modified by Schedule 2A of the UK MDR 2002) which contains provisions relating to the drawing up of a statement containing the information detailed below and the keeping of documentation relating to the device.

If the custom-made device in question would have been classified as either a class IIa, class II(b) or class III device, within the definition of a medical device or is an active implantable medical device then that device must be accompanied by the statement referred to in:

for medical devices: Part II of the UK MDR 2002, Annex VIII (as modified by Part II of Schedule 2A of the UK MDR 2002)
for active implantable medical devices: Part III of the UK MDR 2002, Annex VI (as modified by Part II of Schedule 2A of the UK MDR 2002)

It should be noted that the statement does not need to be provided with a custom-made device which has been classified as class I.

It is the responsibility of the manufacturer of the device to review all the requirements of the UK MDR 2002 against their procedures. This statement must include:

data allowing identification of the device in question, i.e. description, serial number, order number, generic name
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)
the name of the qualified person, medical practitioner or other authorised person who made out the prescription and, where applicable, their place of work
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
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
the name and address of the manufacturer

Additionally, the manufacturer must retain and, upon request, make documentation available to the Competent Authority, allowing an understanding of the design, manufacture and performances of the product -including the expected performances - so as to allow assessment of conformity with the requirements of the UK MDR 2002. The documentation for all active implantable medical devices shall be kept for a period of at least 15 years from the date of manufacture.

The ‘statement’ should be available to the named patient for whom the device has been manufactured. It is a requirement that patients are made aware that they can request a statement and the statement will need to be made available on request. Whilst the technical document issued with the device should indicate if the manufacturer operates from more than one site, this need not be included in the statement.

We have examples of how this requirement for custom-made medical devices can be met.

Question 6

Post-market surveillance, corrective action and vigilance procedure

Accepted Answer

Manufacturers of custom-made devices are required to review and document experience gained in the post-production phase and to set up a post-market vigilance system of reporting to the MHRA.

Specifically, manufacturers need to report any incidents resulting from the constituents or design of the device if they pose a serious risk to public health, or the manufacturer initiates a field safety corrective action (e.g. a recall).

Ordinary return of devices to manufacturers for adjustment or fitting would not need to be reported.

More detailed guidance on vigilance is available in the vigilance and adverse incidents guidance.

Question 7

Registration

Accepted Answer

A manufacturer of custom-made devices or their UK Responsible Person must register with the MHRA. Registration will include a description of the devices concerned and the business address. This requirement applies to both general medical devices and active implantable medical devices. More detailed guidance on registration is available in the registration of medical devices guidance.

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