Changes in the law post – Brexit regarding the registration of medical devices mean manufacturers, distributors and importers must follow new rules and guidelines. ASAP UK has already created all the necessary product technical files and is working towards meeting the requirements for registration under the new law; the company aims to be among the first to achieve this.
The Medicines and Medical Devices Act 2021, which dictates how the UK medical technology industry is regulated post – Brexit, came into effect on 1st January 2021; a key change is that the Medicines and Healthcare products Regulatory Agency (MHRA) is now solely responsible for registering medical devices for the UK market.
ASAP UK follows closely all legal and regulatory changes; the company’s products are Class I Medical Devices and fall under EU Directive 93/42/EEC, which continues to apply in the UK. Class I devices are subject to a grace period and must be registered from 1 January 2022.
The new rules apply only to Great Britain; there are different rules for Northern Ireland. CE marking will continue to be recognised in Great Britain until 30 June 2023.
Madan Natarajan, General Manager at ASAP UK, commented; “Our commitment to adhering to all relevant Standards and Protocols is absolute; indeed, our company is built around this. We will always comply with new laws or changes to existing laws, which is critical to our customers as they must have complete confidence in our products.”
Under the new law, manufacturers based outside the UK must appoint a single UK Responsible Person (UKRP) to register the device with the MHRA; importers and distributors are not required to appoint a UKRP. If a medical device was registered with the MHRA before 1 January 2021 then it does not need to be re-registered.
ASAP UK was founded in 2019 and is part of a group that started in Malaysia as ASAP international in 1988; the company now has a presence in over 80 countries worldwide.
The company is launching its range of Cleanroom gloves at the Cleanroom Technology Conference at the National Conference Centre in Birmingham on September 14th - 15th; ASAP is on Stand E7.
For further information about the new guidance and the role of the MHRA see here www.gov.uk/guidance/regulating-medical-devices-in-the-uk.