BHTA outlines important regulatory advice for mobility retailers, manufacturers and importers, ahead of possible no-deal Brexit
As the 29th March 2019 draws closer, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance setting out how medical devices will be regulated in the UK in the event of a no-deal Brexit, affecting retailers, distributors and manufacturers in the mobility and healthcare industry.
Ensuring that companies in the industry are kept up-to-date with the new guidance, the British Healthcare Trades Association (BHTA) has outlined key points for each segment of the market.
If there is no deal with the European Union, the UK’s current participation in the European regulatory network for medical devices would end, and the MHRA would take on the responsibilities for the UK market currently undertaken through the EU system.
Highlighting the need for businesses in the mobility sector to be aware of the potential changes, Andrew Stevenson, interim Director General of the BHTA, commented: “With Ministers and Parliamentarians still unclear about what will be happening next month, the Government is continuing to step up the provision of guidance in preparation for a potential ‘No Deal’ outcome. The BHTA, and all business organisations, have expressed concern again about the uncertainty over how international trades may be conducted and regulatory frameworks changed at short notice.
“At the request of the MHRA, we are passing on their advice about necessary preparations to be made allowing for leaving the EU without an agreement.”
Setting out how Medical Device Regulations will be transposed into UK law, mirroring most of the EU requirements, the Trades Association says the advice serves as a timely reminder of some of the new obligations which are coming into place, regardless if the UK leaves the EU or not.
What is the UK Responsible Person role and why is it important for manufacturers?
From the 29th March 2019, if no deal is reached with the EU, a manufacturer established outside of the UK must have an appointed UK Responsible Person who acts of its behalf to carry out specified tasks in relation to the manufacturer’s obligations, including registering with the MHRA before a device is placed on the UK market.
Importantly, the manufacturer must have someone physically located within the UK for the MHRA to communicate with, with the individual providing an address to be used for official communications where they can be reached.
This individual will also be required to keep certain information at the disposal of the MHRA, such as declarations of conformity and technical documentation.
What about placing products into the EU market from the UK?
In the event of no-deal, any UK-based Authorised Representative will no longer be recognised under EU law and unable to carry out tasks on a UK manufacturer’s behalf for the purposes of placing products on the EU market.
Manufacturers with a UK-based Authorised Representative will need to establish a new Authorised Representative based in the EU.
For mobility retailers and distributors selling medical devices
Distributors – defined as “any person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market” – are not normally liable for harm to consumers or their property caused by an unsafe product, as long as they identify the producer, however, do have some responsibility for safety and can face enforcement action.
From 26 May 2020, mobility shops and wholesalers selling medical devices will have to ensure the devices they are selling are CE marked, are accompanied by relevant information to be supplied by the manufacturer, and that the importer has complied with their general obligations.
Additionally, it is the responsibility of the retailer or distributor to ensure a Unique Device Identifier (UDI) has been assigned to the device – essentially, that there must be an identifier such as a barcode on the device, to enable it to be tracked and traced.
For importers of medical devices
From 26 May 2020, importers – defined as “any person established within the UK that places a device from a country outside the UK on the market – will be responsible for checking that medical devices they place onto the market have been CE marked, as well as ensuring the manufacturer is identified and has a UK Responsible Person.
In addition, importers must verify that the device has been labelled correctly and a UDI has been assigned to the device, as well as ensuring the device is registered with the MHRA.
For manufacturers of medical devices
In the event of a no-deal Brexit, manufacturers wishing to place a medical device on the UK must ensure it is registered with the MHRA and if that manufacturer is based outside of the UK, it must designate a UK Responsible Person – see our section on what is a UK Responsible Person.
Transposing the relevant requirements for the EU Medical Device Regulations, there are additional responsibilities for manufacturers, including correctly classifying the device against the new risk classification criteria and meeting general safety and performance requirements, including for labelling and technical documentation and quality management systems.
In addition, manufacturers must meet increased requirements for clinical evidence where required, ensure a person responsible for regulatory compliance is in place, meet the new vigilance reporting timescales, and create an annual periodic safety update report.
What is classed as a medical device?
Equipment intended for the alleviation of, or compensation for a disability may or may not be considered as medical devices, with the determining factor being if there is a direct link between the corrective function of the equipment and the individual concerned and that there is a stated medical purpose. Products such as hearing aids; mobility aids such as walking frames, crutches, wheelchairs; orthoses; and patient hoists are classed as medical devices.
Some products, however – usually considered aids for daily living – are considered ‘general equipment’ since this equipment may be used by all, rather than having a direct link with a specific individual. Examples include stairlifts, shower seats, commodes and portable ramps.