WIREDGOV

The European Parliament voted in Strasbourg yesterday (22 October) on a new EU law to regulate the manufacture and use of devices to conduct diagnostic tests such as blood glucose monitors or HIV tests.

Removed exemption

However, when first proposed, the new regulation would have removed the current exemption which allows NHS organisations to produce their own devices in-house for specialist tests for patients.

Special patient groups

Specialist NHS organisations, such as NHS Blood and Transplant, produce a variety of diagnostic tests in-house for special patient groups where suitably sensitive commercial devices are not available.

Examples include tests to screen for viral and parasitic transmissible agents; blood tests for clinically significant rare complex blood groups or to assess suitability for blood transfusions and donor transplants.

'Catastrophic impact'  

The inability to continue to manufacture these tests in-house would have resulted in the loss of essential blood and tissue donations, and would have had a catastrophic impact on the provision of essential clinical services across the NHS.

Key vote

Yesterday’s key vote by the European Parliament paves the way for a final round of EU negotiations to agree the new EU regulation.

The NHS Confederation's European Office will continue to engage to ensure the concerns of the NHS are taken into account by EU decision-makers.

'Immensely relieved'

Director of the NHS Confederation’s European Office Elisabetta Zanon said: "We are immensely relieved the European Parliament has listened to our concerns and that NHS organisations will continue to be allowed to produce specialist devices to conduct diagnostic tests for patients.

Devastating impact on patient care

“The loss of these tests would have had a devastating impact on patient care and public health and its impact felt across the NHS for years to come."

Find out more

Find out more about the NHS European Office's work on medical devices.