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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]).

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.

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.

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.

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.

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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.

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.

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.

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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.

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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.

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.

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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.

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.

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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:

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

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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.

This publication is available at https://www.gov.uk/government/publications/medical-devices-legal-requirements-for-specific-medical-devices/medical-devices-legal-requirements-for-specific-medical-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.

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.

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.

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.

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

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

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