UK Aligning Great Britain's High-Risk IVD Standards With EU Specifications

Original from: 360dx

The UK government said Thursday that it will align its regulations on high-risk in vitro diagnostic devices that are sold in Great Britain to align with EU specifications and repeal regulations specific to COVID-19 tests.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) said that it intends to publish amendments this year to its Medical Devices Regulations 2002 to incorporate the EU Common Specifications for high-risk IVDs and repeal the Coronavirus Test Device Approvals rule. It noted that the action follows public consultation that showed overwhelming support for the change.

"By aligning with standards already in place across Europe, we’re not only enhancing patient safety but also making it easier for manufacturers to navigate regulatory requirements across different markets," Rob Reid, deputy director of innovative devices for the MHRA, said in a statement.

The changes would affect IVD devices in England, Wales, and Scotland but not in Northern Ireland, which has separate medical device regulations.

The EU Common Specifications relate to standards for clinical evidence, performance evaluation, sensitivity and specificity, reference materials, measurement traceability, and post-market surveillance.

The UK government said that adopting the EU's common specifications also would help to improve performance standards that are applied to tests for hepatitis B, C, and D, HIV, and syphilis, among other infectious diseases, as well as improve the standards for devices used for blood grouping and tissue typing.

Source: UK Aligning Great Britain's High-Risk IVD Standards With EU Specifications