| answer text |
<p>All medical devices placed on the United Kingdom market must comply with the European
Union Medical Devices Directive 93/42/EEC (MDD). The European Conformity (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.</p><p> </p><p>For
higher risk devices, including hip replacement implants, manufacturers must have the
product’s safety and performance assessed by an independent certification body, called
a notified body, before the CE mark can be affixed.</p><p> </p><p>A notified body’s
tasks will vary depending on the classification of the products concerned, but typical
activities include an examination of the design dossier relating to each type of product,
an assessment of the full technical information, and manufacturer inspections. Under
the MDD, manufacturers are required to have clinical and safety data to support their
performance claims for the device, which is also assessed by the notified body.</p><p>
</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> </p><p>Furthermore, the new European Union Medical
Devices Regulation 2017/745, which entered into force in May 2017, has 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>
|
|
