The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday announced plans to reform medical devices regulation to improve patient health and encourage innovation.
To signify products have met these world-leading standards, they will carry the UKCA marking, a new stamp of certification, replacing the CE mark.
The new measures include: “Making the UK a focus for innovation, and the best place to develop and introduce innovative medical devices – ensuring the new regulatory framework encourages responsible innovation so that patients in the UK are better able to access the most advanced medical devices to meet their needs.”
Our Director of Research, Policy and Innovation Dr Karen Noble said: “The focus on innovation is an encouraging one. The use of devices to improve the effectiveness of drug delivery to brain tumour patients and to reduce the systemic toxicity they endure is one we believe to be vital as we push for improved patient outcomes. Any legislation designed in part to lessen harsh treatments is to be applauded and the Government describes this as ‘an ambitious, transformational programme of reform’ and that is exactly what is needed.”
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