As the professional representative organisations for eye care providers registered optometrists, contact lens opticians, dispensing opticians, and ancillary staff in the UK, we have three overarching objectives in respect of medical devices regulation:
a) patient safety which is paramount
b) patient access to the widest possible range of safe devices to meet individuals’ needs
c) keeping costs of regulatory burdens to the minimum proportionate to risk and consistent with a) and b).
We would therefore argue for:
• the simplest regulatory system possible (commensurate with risk) which is easy for manufacturers, importers, and distributors to apply
• avoidance of any duplication in regulation e.g. that retail opticians are not inadvertently drawn into replicating regulatory requirements already fulfilled by manufacturers, importers or distributors and thus adding unnecessary costs to primary eye care for the NHS and patients.
We are responding only to specific overarching questions in this first round consultation. We look forward to being involved in future work the MHRA undertakes to ensure safe and proportionate regulation of medical devices, including relatively low risk devices such as spectacle frames and contact lenses in the United Kingdom.