Classification of reusable orthopedic instruments used to fit implants
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All surgically invasive instruments can be classified according to Rule 6 and Rule 7 of Annex 8 – Classification rules in the MDR 2017/745. But, before answering your question, I have to state that according to Advisera's policy, we are not authorized to define the classification of medical devices. Therefore, I ask you to consider this answer only as a guideline.
Reusable surgical instruments are classified in a new class according to the MDR – class Ir.
Rationale: Rule 6
All surgically invasive devices intended for transient use are classified as class IIa unless they:
- are reusable surgical instruments, in which case they are classified as Class I.
A drill bit or reamer attached to a power drill and jig used in knee surgery is class IIa:
Rationale: Rule 6 - All surgically invasive devices intended for transient use are classified as class IIa unless they...
or
Rule 7 - All surgically invasive devices intended for short-term use are classified as class IIa unless they...
Under which rule drill bit or reamer will go depends on how long it is used during the operation - if it is below 60 minutes then Rule 6 is valid, and if it is longer than 60 minutes then rule 7 is valid.
Retractors, Gouges, forceps are all reusable surgical instruments and goes under the same classification path as any other reusable surgical instruments – so class Ir.
For more information, see:
- EU MDR Annex 8 – Classification rules https://advisera.com/13485academy/mdr/classification-rules/
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Aug 19, 2021