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Prediction: The MedTech and NHS sector is set to benefit from new reforms

Regulation
Product Safety, Liability and Recall
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Prediction

Following on from the government’s agenda in the UK’s Life Sciences Sector Plan and the 10 Year Health Plan for England, the ongoing reform of medical device regulation in the UK will develop in the coming year. The Medicines and Healthcare products Regulatory Agency has published its consultation outcome on future routes to market and it has announced a consultation on the indefinite recognition of CE-marked medical devices. These initiatives will reduce barriers to market entry with the aim of delivering the latest technologies to patients faster, while also helping boost the MedTech sector. The headline changes include a new international reliance framework, giving patients access to new medical devices approved as safe by trusted regulatory partners such as the United States, Australia and Canada, and removing the requirement for UKCA marking once the proposed system of 'Unique Device Identification' is in place. Indefinite recognition of CE-marked devices would be a welcome move for the industry and safeguard the supply chain and thereby patient access.

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