Practice registration requirements
Background
As an eye care provider in the UK, you will need to register and remain registered with all the appropriate authorities. You will also need to ensure you understand and comply with applicable health professions regulation.
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Ophthalmic optician, optometrist and dispensing optician are protected titles. If you intend to use a protected title in your company or trading name, you must register with the GOC and obtain proof of registration before Companies House will incorporate your business. Failing to register when you are required to do so will make you liable on summary conviction to a fine.
To register with the GOC you must also meet one of the four requirements set out in the GOC’s application form. You can also choose to register if you are not using a protected title but meet one of these registration requirements.
When you are registered with the GOC you will have to comply with its Standards for optical businesses – read our guidance on the Standards.
References:
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You have to comply with legal requirements if you manufacture ophthalmic products such as:
- Ophthalmic appliances – e.g. spectacles
- Contact lenses and solutions
- Instruments and equipment.
This is because these are classed as medical devices – e.g. spectacles are classified as a Class 1 medical device.
If you carry out regulated activities, then you must also follow all applicable regulations. For example, include a CE mark on all products covered by medical device regulations.
If you glaze new products in your business, then you must be registered with the MHRA. You do not have to register with the MHRA if you only repair, refit lenses or replace screws in existing frames etc.
Read sector guidance on registering with the MHRA.
References
MHRA, Medical devices: legal requirements for specific medical products, accessed 24 November 2019.
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As an eye care provider processing personal healthcare data, you will need to register with Information Commissioner’s Office. There are three tiers of fees based on the size of your organisation.
Also see
Other
In some cases, you might need to register with other health regulators, if you perform a regulated activity and do not have an exemption. In most cases, however, primary eye care providers are exempt from these additional regulatory requirements whereas ophthalmology services will need to register. Depending on the location of your practice(s) you should be aware of the following regulators:
- England, the Care Quality Commission – the independent regulator of health and adult social care service providers in England
- Northern Ireland, the Regulation and Quality Improvement Authority – responsible for inspecting the availability and quality of health and social care services
- Scotland, Health Care Improvement Scotland – responsible for regulating independent healthcare services.
- Wales, Healthcare Inspectorate Wales – the independent inspectorate and regulator of healthcare in Wales
Learn more by reading our guide on the regulation of healthcare providers.
If you would like advice and support on this or another regulatory issue, please get in touch [email protected].
You will also need to make sure all the health professionals you engage are registered and remain registered as required by law. Read providing eye care in the UK.
Updates
Originally published: November 2011
Reviewed: January 2020
Next review date: March 2022
Info: The Optical Confederation guidance on completing the RG2 form was developed in collaboration with the MHRA in November 2011. Other resources were added in September 2018 and January 2020 as part of changes to the FODO website.
Reference and notes
The next review was originally planned for December 2021. This was changed due to prioritising work during the pandemic.
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