Medical Devices Regulation
Regulation of medical devices in the UK falls to the Medical and Healthcare Products Regulatory Authority (MHRA). The UK, through the MHRA, is currently a member of the European devices regulatory framework.
The EU Medical Devices Regulation ((EU)2017/745) entered into force on 25 May 2017. During its implementation period it will gradually replace the existing Medical Devices Directive and will apply in full from May 2020. Although the implementation period for the MDR crosses the Brexit date (29 March 2019), The Government will comply, and align UK law, with all key elements of the Medical Devices Regulation (MDR).
Our briefing provides more information on the current regulatory framework for medical devices in the UK and what may happen after Brexit.
Spectacle frames and lenses are Class 1 medical devices. Optical practices should be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA) for “assembly” of spectacles. “Assembly” is the act of putting together lenses and frames to make complete spectacles. This requirement only applies to new products, i.e. assembling new lenses into new frames. New frames and lenses must both be CE marked. Before registering with the MHRA a conformity assessment must be undertaken in order to put the CE mark on products.
The registration process has changed since the following Optical Confederation guidance was created, but the definitions and detail surrounding when to register remains the same.
Registration currently costs £100. Full details regarding MHRA registration can be found here.
Detergent and Disinfectant Wipes
The MHRA issued a warning – on 27 March 2013 – that some detergent and disinfectant wipes have been reported to damage plastic surfaces of medical devices (equipment).
The main risk/concerns are:
- that the compromised surface may not clean properly in the future – increasing risk of infection etc.
- the damaged surface may interfere with diagnostic results.
Members should refer to manufacturers guidelines on decontamination to ensure:
- devices remain fit for use
- that patients are not put at risk – e.g. infection, incorrect readings that may affect the accuracy of a diagnosis
- registrants should be made aware of the optimal way to clean equipment
- contract cleaners should either avoid cleaning clinical equipment in the practice or be trained to do so
- check for any damage to plastic surfaces on medical devices currently in use
- if manufacturer instructions on cleaning/decontamination are insufficient you should contact them for written clarification and also inform the MHRA.
In general, even for metallic medical devices, the advice above should be followed.