I'm working for small medical device (OEM) supplier firm in Turkey. And we produce bone wire, bone plates , bone clamps, bone nails, bone screws, joint prosthesis, external fixators, spinal implants. All of them are 2b products -required Technical File- until 1st September 2007. Because EU Commission Directive 2005/50/EC (Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices) submitted and our products class 3 products now -required Design Dossier-

So, what will we do? (any information, idea, interpretation, source etc.)

Thank you...

PS: Related docs attached.

I'm working for small medical device (OEM) supplier firm in Turkey. And we produce bone wire, bone plates , bone clamps, bone nails, bone screws, joint prosthesis, external fixators, spinal implants. All of them are 2b products -required Technical File- until 1st September 2007. Because EU Commission Directive 2005/50/EC (Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices) submitted and our products class 3 products now -required Design Dossier-

So, what will we do? (any information, idea, interpretation, source etc.)

Thank you...

PS: Related docs attached.It appears the weight bearing components have been reclassified. Apparently You will need clinical data for these components. As always, check with your Notified Body.

Hi

Firstly work out whther your devices are covered, this is specifically load bearing, hip, knee and shoulder joint replacements and not the "ancillary implanted components". Secondly, if your products are already on the market, you have until 2009 or 2010 to make the changes.

But probably the most important point, as Al says, is to talk to your Notified Body, alternatively, get your EU Rep to talk to the NB.

i'm just preparing the audit. Everybody knows that there are more than one method/route for CE Marking. But, one of them is cheap and one of them expensive. We are small company and we must choice appropriate route.

For a class III device you also need a Examination of the design of the product (Annex II.4) or a EC Type-Examination (Annex III), depending on your conformity assessment procedure - Annex II or Annex V (or IV).

Ask your NB, if the design examination or type examination is the cheaper way (design examination must be performed by the same notified body that performs the Annex II.3 full quality assurance system certification, EC-type examination can also be performed by an other notified body).

Ah yes, and the reclassification only applies on "hip, knee and shoulder total joint replacements"