ASAP Innovations outlines the latest legislation changes concerning Britain’s medical industry
Following Britain and Northern Ireland’s formal exit from the European Union on January 1 2021, The Medicines and Medical Devices Act 2021 is now in force and presiding over British medical regulations post-Brexit.
As one of the first manufacturers to ensure their products are certified and ready for post-Brexit distribution, ASAP Innovations offers a first-hand account on steps and procedures businesses must take to ensure they fall in line with the new regulation.
Sean Keller, Managing Director of ASAP Innovations explains: “in the wake of Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) now finds itself as the sole body responsible for the regulation of medical devices in England, Wales and Scotland (Great Britain).
“Since 1 January 2021, all medical devices placed on the Great Britain market need to be registered with the MHRA. Medical devices currently sold across the Britain can still display the CE mark, a requirement under EU law since 1985, but medical device companies with products on the UK market must now focus and plan for how they will attain a UK Conformity Assessment (UKCA mark)”.
Sean continues: “in post-Brexit Britain, all medical devices within the British market must now be registered with the MHRA. There are some dates to bear in mind for grace periods, one of which has already passed – here are the key dates:
|Device Category||Deadline for registration|
|Active implantable medical devices
Class III medical devices
Class IIb implantable medical devices
IVD List A products
|Class IIb non-implantable medical devices
Class IIa medical devices
IVD List B products
|Class I medical devices
“Medical devices can still be placed onto the UK market using a CE mark until 30 June 2023, but as of 1 July, all medical devices and in vitro diagnostics (IVDs) now require a UKCA mark to be sold.
“Northern Ireland is the only region which is not affected by these changes, meaning that CE-marked devices will continue to be sold across Northern Ireland and no other UK nation” explains Sean.
Sean continues: “moving forward, for manufacture and supply of medical devices in Britain, MHRA registration is lawfully required. However, if a medical device has already been registered with the MHRA before 1 January 2021, there is no requirement for re-registration, but there is a requirement to ensure the information held by the MHRA remains compliant. There is also a new requirement for manufacturers based outside of the UK to assign a UK Responsible Person (UKRP) to register and act on their behalf.
“The UKRP should be appointed as soon as possible to allow time to process documentation and ensure compliance before registration with MHRA. It is recommended that the UKRP has the required skills and competence to understand the changing regulatory environment and continue to represent your company. Importers and distributors are not required to appoint a UK Responsible Person” concludes Sean.
ASAP Innovations UK has over 30 years’ experience manufacturing disposable products with a commitment to hygiene control and quality assurance. ASAP Innovations has 150 certified product lines of masks and gloves available to UK organisations and is based in Ireland and Malaysia.
ASAP Innovations UK ensures that each design meets current trends and abides by all regulatory requirements, with all its masks and gloves tested and certified by authorised notified bodies.