Medical Devices Directive – Brief Overview

The Medical Devices Directive applies to the medicallevels' promised by manufacturers. This Medical
devices industry which is responsible forDevice Directive also contains additional articles not
manufacturing some of the most essential productsfound in the original document of 1976. These include
for patients, hospitals and medical professionals beingextra provision for the protection of breast implant
used in the medical world today. They includemedical devices, further consideration, regulation and
anything from low-risk items such as first aidprotection over the transmission of transmissible
bandages and surgical gloves to higher risk items likespongiform encephalopathies through medical devices
heart valves to breast implants.that have been made from materials deriving from
Of course it's essential for any business involved inanimal tissues and the reclassification of breast
making items used for saving lives and making sickimplants, knee, shoulder and hip joints.
people better to be regulated properly so that theFor most patients, the Medical Devices Directive
items they produce are high in quality, use the bestwon't make a visible difference to their treatment or
materials available and are ultimately safe to thein the way that they are nursed in hospital or
end-users. One way that medical professionals areconsulted by doctors and specialists. What the
regulated therefore is through the Medical DevicesMedical Device Directive will do however, is to ensure
Directive, which was last updated in 1993 (Directivethat patients get the very best care, advice and
93/42/EEC).treatment with the best products at all times –
The Medical Device Directive's primary objective is toas well as helping to guarantee that behind the
give patients who come into contact with, who usescenes, the medical devices industry remains
and are treated with medical devices are given thecomplaint, well regulated and accountable for its
‘high level of protection' and ‘performancework.