The government of the United Kingdom is working to align its requirements for certain medical devices with those of the European Union (EU).
According to a news item posted to the website of Pharmacy.biz, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is proposing changes to the UK’s 2002 medical device regulations to incorporate specific requirements for high-risk in vitro diagnostic (IVD) devices that are consistent with those currently in effect in the EU.
The proposed changes will reportedly be incorporated into regulations later this year as part of the UK Government’s efforts to reform its current medical device regulations.
Rob Reid, the Deputy Director of Innovation Devices at the MHRA says that the changes “will improve patient safety,” while also making it easier for manufacturers to “navigate regulatory requirements across different markets.”
In addition to the changes regarding IVDs, the MHRA is also calling for the repeal of regulations applicable to the approval of Coronavirus testing devices.
The Pharmacy.biz article about the planned regulatory changes in the UK is available at https://www.pharmacy.biz/patient-safety-2673091768/.
