Following the UK’s exit from the European Union (EU), the government identified a unique opportunity to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the United Kingdom. Powers in the Medicines and Medical Devices Act (2021) allow for amendments the Medical Devices Regulations 2002 which govern medical devices in Great Britain.
The MHRA ran a consultation on proposed changes to how Devices are regulated in the UK between September and November 2021and the government have now issued their response to that consultation:
In this 155 page document the Government has outlined how it plans to respond to all issues regarding the regulation of medical devices, however for distributors of devices there are a few keys points to scrutinise:
Section 13 – Obligations of Importers and Distributors:
The consultation invited views on a number of obligations that could be introduced for importers and distributors of devices, to support better accountability, transparency and safety. Further detail on these requirements is set out in the consultation document.
The government’s response:
The consultation set out a number of obligations on importers and distributors that could be introduced. After careful consideration of all responses, the government intends to proceed with the proposal to introduce obligations on importers and distributors, as outlined in the consultation. We will give further consideration to the concerns raised regarding the ability of importers and distributors to ensure that the end user does not receive a time expired device. We consider that this approach will improve device traceability, helping to ensure the safe supply of medical devices to the UK market. Some respondents indicated that additional guidance may be necessary to clarify the roles and responsibilities of importers and distributors, and the government intends to produce supplementary guidance on the regulatory requirements.
After careful consideration of consultation responses, the government intends to proceed with the proposal to require economic operators to inform the MHRA if they are aware of any issues that will interrupt supply or cause a shortage of medical devices on the UK market. The MHRA will take account of consultation feedback regarding the need to set clear requirements and intend to publish supplementary guidance, alongside the regulatory changes, that will address these points.
These additional requirements may not have significant impact on some suppliers but may have on others. The supplementary guidance will be eagerly awaited to add further clarification. As always, if you require any support in the management of your supply of Medical Devices Pharmacy Consulting are always on hand to provide whatever help you need.https://pharmacyconsulting.co.uk/contact/