Guidance

Medical devices: legal requirements for specific medical products

Updated 1 July 2023

Read this for information on how to comply with the legal requirements for prosthetic, orthotic and ophthalmic devices. The guidance includes:

• classification
• custom-made prosthetic, orthotic and ophthalmic devices
• examples

This guidance is specific to medical devices placed on the market in Great Britain. For guidance on the legislation applicable to medical devices in Northern Ireland, please see our published guidance.

The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime

Prosthetic and orthotic devices

This guidance is for external prostheses and orthoses only.

All manufacturers should check the Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) to see if their product meets the definition of a medical device.

Most prosthetic and orthotic devices are either:

• Class I with a UKCA, CE or CE UKNI marking
• custom-made devices
• systems made up of multiple UKCA, CE or CE UNKI-marked devices, where each one is used for their intended purpose – these devices should be used as intended by the manufacturer

CE marked medical devices continue to be accepted on the Great Britain (England, Wales and Scotland) market with the deadline for acceptance depending on the type of device and the legislation it complies with. The latest of these deadlines is 30 June 2030.

Systems that include a device(s) without a UKCA, CE or CE UKNI mark, or used outside of its intended purpose, will be considered a device in its own right. This does not apply to sockets.

See examples of prosthetic and orthotic medical devices.

You need to follow the relevant essential requirements for your device in (Part II of the UK MDR 2002, Annex I [as modified by Part 2 of Schedule 2A to the UK MDR 2002]).

Manufacturers and healthcare establishments who supply medical devices to be placed on the market either for use or distribution, at a cost or free of charge, must follow the regulations. This applies to new or fully refurbished devices and those not intended for a clinical investigation. See our guidance on in-house manufacturing for more information.

You will automatically become a manufacturer if you refurbish a prosthetic/ orthotic device outside of the original manufacturer’s instructions. You need to follow the regulations in the MDD and register as a class I manufacturer if this is the case.

You will automatically become a manufacturer if you refurbish a prosthetic/orthotic device outside of the original manufacturer’s instructions. You need to follow the regulations in the UK MDR 2002 and register as a Class I manufacturer if this is the case.

Contact a suitable Notified Body or UK Approved Body to get your device certified if it is not Class I.

You will also need to report incidents as part of your vigilance procedures once the device is on the market.

Activities not covered by the UK MDR 2002

Activities around prosthetic and orthotic medical devices that fall outside the scope of the regulations include:

• aligning, fitting or assembling the medical device
• medical devices that are manufactured by a healthcare establishment - for example a device made in an NHS workshop and given to a patient under its care, even if the patient is referred from another NHS trust

This also applies to custom-made devices although you still need to follow the general law around consumer protection and product liability. You must ensure the safety of patients, users and any third party.

Prosthetic devices

The MHRA considers an external prosthetic device to be made up of 2 parts - hardware and a prosthetic socket.

The hardware of a prosthetic device refers to all the components up to where the socket is. Some of those components may require a UKCA, CE or CE UKNI mark while others may be custom-made.

A prosthetic socket could be:

• an accessory to the medical device, which is treated as a medical device in its own right - this is covered by the UK MDR 2002 as it would be attached to the assembled hardware to be used as intended
• custom-made according to the instructions of a healthcare professional, prosthetist or prescribing officer to meet the specific needs of a patient – this should include instructions by the manufacturer for how to put it together

The hardware and prosthetic socket are joined together according to the manufacturer’s instructions.

Modular prostheses

These types of medical devices are made up of multiple components and are considered to be Class I, which are generally low-risk devices requiring a UKCA, CE or CE UKNI mark. They need to be assembled according to the manufacturer’s instructions and adapted for individual patients.

Orthotic devices

Classification

Most orthotic devices are classified as Class I. This includes:

• orthotic kits/parts that have been mass produced (e.g. swivel walkers) and can be adjusted according to height
• reciprocating gait orthoses
• mass produced/stock item orthotic device which does not give energy to the user such as cervico thoracic orthoses
• mass produced footwear and insoles or segments for making insoles – if the manufacturer doesn’t intend for the insoles to have a medical function, they will fall outside the regulations

Orthotic devices are considered to be Class II if they support mobility with functional electrical stimulation (FES), where energy is given to the user.

All medical devices except custom-made devices, and devices for clinical investigations, must bear an appropriate mark demonstrating conformity to the relevant medical device legislation.

Examples of prosthetic and orthotic devices

Prosthetic devices

Limb type/component	Custom-made device	Class I UKCA/CE/CE UKNI-marked device
Lower limbs
Modular hip		x
Modular knee		x
Modular gain control (includes IP unit)		x
Modular shin		x
Modular ankle		x
Modular foot		x
Partial foot (chopart)	x
Non-modular limbs (conventional limbs)	x
Upper limbs
Hand (including myoelectric)		x
Terminal device (ie split hook)		x
Wrist		x
Forearm		x
Elbow		x
Shoulder		x
Partial hand	x
Prosthetic sockets	x when supplied on written prescription for the sole use of a particular patient	x when considered ‘accessories’ within the definition of the UK MDR 2002

Orthotic devices

Type of orthosis	Custom-made device	Class I UKCA/CE/CE UKNI-marked device
Cervical orthosis (from a cast)	x
Cervical orthosis (stock item)		x
Cervico-thoracic (from cast)	x
Cervico-thoracic (stock item)		x
Cervico-thoraco-lumbo-sacral (CTLSO from cast)	x
CTLSO (from stock items)		x
Footwear - bespoke (from cast/last)	x
Footwear (stock item, mass-produced)		x when placed on the market principally for a medical purpose
Shoulder, elbow, hand, wrist, knee, ankle orthoses etc	x when made direct from casts (eg ortholen splints) or from measure charts	x when supplied as stock items
Stock footwear / shoes		x when mass-produced for a cross-section of users and adapted as necessary for individual patients (manufacturers should provide guidelines for acceptable adaptations)
Stock inlays, insoles and mass-produced segments for making insoles		x only when intended for a medical purpose
Swivel walkers and standing frames		x these are supplied as a kit of parts and assembled in accordance with the component/kit manufacturer’s instructions
Reciprocating gait orthoses		x note: the electrical stimulation equipment for electrical impulse action is Class IIa as it imparts energy to the user

Custom-made prosthetic and orthotic devices

Orthotic devices are generally custom-made if they are made up of a mixture of Class I UKCA, CE or CE UKNI-marked devices, such as knee joint side members and devices designed for individual patients. They are also custom-made if they are made to fit from casts, for example, cervical, cervico, thoracic, orthotic splint, bespoke footwear.

See guidance on custom-made devices for more information.

Ophthalmic products

If you are manufacturing an ophthalmic product, you must follow the UK MDR 2002.

Ophthalmic products include:

• ophthalmic appliances (e.g. spectacles)
• contact lenses and solutions
• instruments and equipment

You must include a UKCA, CE or CE UKNI mark on all ophthalmic products covered by the regulations except for custom-made devices. This shows that you have met the legal requirements applicable for your device. See guidance on conformity and UKCA marking for more information.

Classification

The classification of your ophthalmic product depends on the possible risk associated with it. Most ophthalmic products fall into a Class I category but you need to follow the guidance on classifications to know which category your device fits into.

You must get your device approved by a Notified Body or UK Approved Body if it is Class IIa, IIb, III or if it is a Class I sterile/measuring device.

Generally, your device will be:

• Class I if it is considered to be low risk (e.g. spectacle frames, lenses, trial sets, ready-made spectacles, ophthalmoscopes)
• Class IIa if it has a medium risk such as contact lenses
• Class IIb, which is also medium risk such as contact lens care products, surgical lasers and phacoemulsification and/or viteoretinal systems
• class III if it is considered high risk for example, contact lenses containing medicinal substances

Activities relating to ophthalmic products

You must follow the regulations set out in the UK MDR 2002 if you are carrying out certain activities related to ophthalmic products. These activities include:

• glazing, which involves cutting and fitting the finished lenses into the frames – this is recognised as an assembly of devices and all glazing shops must be registered with the MHRA
• surfacing, which is to finalise the surface of the lens – those carrying out surfacing work are considered manufacturers of a Class I medical device and should follow the regulations as well as register with the MHRA
• post-market surveillance – you must report all adverse incidents to the MHRA if the medical device is covered by the UK MDR 2002

Activities not covered by the UK MDR 2002 include:

• normal activities of medical practitioners, optometrists, dispensing and manufacturing opticians (e.g. eyesight testing)
• repairing broken appliances, refitting lenses or replacing screws, including for spectacles already being used

Custom-made devices

Most ophthalmic products are not custom made, such as lenses as they are mass-produced and adapted to an individual’s needs. If a healthcare professional prescribes a bespoke spectacle frame to fit a certain face shape, it is considered a custom-made device.

You need to register with the MHRA if you are manufacturing a custom-made device.