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Joint replacements to face tougher checks

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Joint replacements have been reclassified by the European Commission from medium risk to high risk medical devices.

Joint replacements have been reclassified by the European Commission from medium risk to high risk medical devices.

They will now face tighter safety and quality checks before they can be marketed in the UK. Regulators said they had been concerned about hip implant performance for several years and the resultant risk of premature implant failure.

John Williams, chair of the Committee on the Safety of Devices at the Medicines and Healthcare Products Regulatory Agency, said: 'The rate of development and the complexity of many such devices necessitates greater stringency being applied.'

John Getty, president of the British Orthopaedic Association, added: 'It is absolutely essential that devices implanted in the human body come under the most stringent regulatory control possible under the medical devices directive.'

www.mhra.org.uk

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