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<p>The Government is committed to the safe and effective regulation of medical devices
in the United Kingdom; we continue to strengthen safety while ensuring patients and
the public have fast access to new, innovative devices.</p><p>All medical devices
placed on the UK market must comply with the European Union Medical Devices Directive
93/42/EEC (MDD). The CE mark for a device is placed on a product by a manufacturer
to attest to its compliance with the safety, quality and performance requirements
of the MDD, before it can be placed on the market, which includes supply to the National
Health Service.</p><p>Once a device is placed on the market, the manufacturer is required
to continually monitor the performance of their device, submit vigilance reports to
the Medicines and Healthcare products Regulatory Agency (MHRA) when incidents occur
involving their device and take appropriate safety action when required. Additionally,
the MHRA monitors adverse incident reported though the Yellow Card reporting system.
Adverse incident reports can be submitted to the MHRA by members of the public, healthcare
professionals and the device manufacturer.</p><p>Furthermore, the new EU Medical Devices
Regulation 2017/745 (MDR), which entered into force in May 2017, have introduced more
stringent requirements from manufacturers to ensure a high level of patient safety.
These include increased scrutiny by notified bodies, particularly for higher risk
devices, new standards for clinical evidence and more rigorous vigilance reporting
requirements.</p><p><strong> </strong></p>
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