Dear Burcinerek,
Best greetings of the day!!!
The Directive on the reclassification of Total hip, knee and shoulder replacements was formally adopted in August 2005 and published in the Official Journal of European Communities on 12 August 2005.
The Directive defines a hip, knee or shoulder replacement as- “an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint. Ancillary components (screws, wedges, plates and instruments) are excluded from this definition.”
The Directive is applicable to all implantable components which are parts of a load bearing total joint replacement system intended to provide a function similar to a natural hip, knee or shoulder.
The word “total” is interpreted as meaning to replace both opposing articulating surfaces of the joint, so the Directive covers-
a) both the femoral and the acetubular surfaces of the hip
b) both the femoral and the tibial surfaces of the knee
c) both the femoral and the tibial surfaces of the knee
Uni-compartmental knee components and hip resurfacing devices fall within the scope of Directive, as these devices replace both articulating surfaces. Partial joint replacements, i.e. hip hemiarthroplasties, are excluded from the Directive as are ancillary components such as screws, wedges, plates and instruments.
If hip, knee and shoulder replacements have been subject to Annex II section 3.2 conformity assessment, under the Medical Devices Directive they must undergo a complementary assessment procedure under Annex II section 4 and have an EC Design Examination certificate issued as required by Article 3.1 of the reclassification Directive. Alternatively the manufacturer can choose another route, he may submit an application for the Annex III EC type-examination procedure, coupled with an Annex IV EC verification or Annex V production quality assurance procedure.
If hip, knee and shoulder replacements have been subject to a conformity assessment under Annex III coupled with Annex VI product quality assurance, any of the available conformity assessment routes for a Class III device can be chosen as a complementary assessment. As specified in Article 3.2 of the reclassification Directive.
I hope i was able to clear your doubt.
B.R.
Sharad