In general, a medical device cannot be marketed in Europe without carrying a CE marking. A CE marking is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.For all but the very lowest risk devices, such as unmedicated bandages, this must be verified by an independent certification body, called a Notified Body, before the CE marking can be affixed. The MHRA is responsible for appointing UK Notified Bodies and regularly audits them to ensure that they perform to high standards.
Manufacturers should be able to support their performance claims for the device. In many cases,
and in particular for higher risk devices, this information will come from a clinical trial. Where
a manufacturer plans to carry out a clinical trial in the UK, agreement must be obtained from the MHRA. On average, the Agency refuses one in five such requests on the grounds of patient safety or health policy restrictions.
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