Mechanical Testing for Orthopaedic Implants for CE Marking

[mpfizer]

We manufacture orthopaedic implants viz plates , screws , nails we are applying for CE mark .We have different types of screws viz cortical , cancellous , malleolar , dhs etc in various diameters and lengths , the same is the case for plates and nails

Notified body is asking us to do mechanical testing as per ASTM F 382 , 384 , 1264 etc for each and every type of screw and plate is that justified??

Is there any guideline on this ?

michelle

 

[Marcelo]

Notified Bodies should not ask for particular testing, they should inquiry how you comply with essential requirements (and testing is obviously part of it).

On the other hand, tests for implants are usually defined in ASTM standards, so I would say it?s a general expectation that you use those.

 

[yana prus]

Hi Michelle,

While conducting the mechanical testing (including but not limited to static and dynamic loading fatigue tests), you should determine based on your design what is your worst case for testing, and then based on the worst case testing whether the other devices are covered in the testing.

There is a useful FDA guidance: Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080222.htm#4 where the section IV deals with product testing - their rational for the testing may be very helpful for you while negotiating with the NB with regards to the extend of the necessary testing.

Good Luck,

Yana