Gynaecological examinations and procedures can often be daunting for patients. Both patient and clinician require a vaginal speculum that is safe and comfortable with no risk of cross-infection. Instraspec Contour® addresses these needs and more thanks to thoughful design and the use of advanced materials in its manufacture.
It is a legal requirement for all medical devices to comply with the Medical Devices Directive (MDD) 93/42 EEC and carry the CE mark. Regulatory requirements differ according to the risk attached to the use of the product. The lower the risk, the easier it is to comply with the Directive.
Single-use instruments are relatively high risk as many are surgically invasive and therefore classified as lla devices. They are therefore subject to greater levels of control than reusables, which are Class l devices except those used on central nervous tissue. Class l devices can be sold without any authorisation from an independent third party - a Notified Body. Class lla devices require a Notified Body to assess the production of the device to Annex lV, V or Vl of the Directive and issue a certificate of conformance before a CE mark can be applied and the product legally sold.
Certification by the British Standards Institution (BSI) verifies that Instraspec Contour® products meet fully the requirements of the Regulation.