R10.2 Medical Devices

R10.2 Medical Devices

R10.2.1 Medical devices used in optical practice are regulated in the UK under the Medical Devices Regulations 2002 (UK MDR 2002), as amended. These regulations apply in Great Britain (England, Scotland and Wales) and are overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). In Northern Ireland, due to the Windsor Framework, medical devices continue to be regulated under the EU Medical Device Regulation (EU MDR) 2017/745. The regulations define a medical device as any instrument, apparatus, appliance, software or related article intended by the manufacturer to be used for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or injury. Under this definition, equipment commonly used in clinical eye examinations is regulated as medical devices, including (but not limited to): autorefractors, phoropters, tonometers, visual acuity charts, retinoscopes, slit lamps, optical coherence tomography (OCT) systems, keratometers and corneal topographers. All such equipment must comply with the applicable regulatory framework and be supplied by appropriately registered manufacturers or suppliers. Devices must meet general safety and performance requirements, be supported by appropriate technical documentation, and undergo conformity assessment in line with their risk classification. In Great Britain, devices placed on the market must be registered with the MHRA and bear the appropriate UKCA marking (with transitional recognition of CE marking where permitted). In Northern Ireland, devices must comply with EU MDR requirements and bear a CE marking, with registration through the EU system where applicable.

R10.2.2 Prescription spectacles, including frames and lenses, are classified as medical devices as they are intended by the manufacturer to correct vision, which constitutes a medical purpose under the UK Medical Devices Regulations 2002 (UK MDR 2002), as amended, and the EU Medical Device Regulation (EU MDR) 2017/745. Ready-made reading spectacles are also within scope where they are intended for vision correction. As medical devices, spectacles must comply with applicable safety and performance requirements and be supported by appropriate conformity assessment and technical documentation. In Great Britain (England, Scotland and Wales), medical devices placed on the market must meet UK MDR requirements, be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), and bear the UK Conformity Assessed (UKCA) marking, with continued recognition of CE-marked devices under current transitional arrangements. The ongoing recognition of CE marking in Great Britain has been extended and remains under review for longer-term implementation. In Northern Ireland, medical devices must comply with EU MDR requirements and bear a CE marking, in line with the Windsor Framework. Where required, conformity marking should be applied to the spectacle frame and/or accompanying documentation, and to the packaging or product labelling of spectacle lenses, in accordance with regulatory guidance and manufacturer instructions.

R10.2.3 Contact lenses are classified as medical devices under both the UK Medical Devices Regulations 2002 (UK MDR 2002), as amended, and the EU Medical Device Regulation (EU MDR) 2017/745, due to their intended purpose and direct contact with the eye. Their use for vision correction or cosmetic alteration places them within the scope of full regulatory oversight, with classification and conformity requirements reflecting their risk profile. Contact lenses placed on the market must comply with applicable safety and performance requirements and undergo appropriate conformity assessment. In Great Britain (England, Scotland and Wales), devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and bear the UK Conformity Assessed (UKCA) marking, with continued recognition of CE marking under current transitional arrangements. In Northern Ireland, contact lenses must comply with EU MDR requirements and bear a CE marking, with registration through EU systems where applicable. Cosmetic (non-corrective) contact lenses are also regulated as medical devices and are subject to the same regulatory, safety and labelling requirements as corrective contact lenses.