Category:Patient Specific Implants
A Patient Specific Implant is a medical device wicht is tailor made for an individual patient:
The definition according to the Medical Devices Directive:
‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.
custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.
These devices shall not bear the CE marking.
Media in category "Patient Specific Implants"
The following 2 files are in this category, out of 2 total.
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Patient Specific Implant.png 1,141 × 1,146; 1.2 MB
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Xilloc Patient Specific Implant Titanium.png 2,880 × 1,080; 11.87 MB
