in which class are reusable orthopedic instruments used to fit implants classified ?
A drill bit or reamer which are attached to a power drill in which class would they fall?
A jig used in knee surgery which is used to take knee cuts would fall in which class
Retractors, Gouges ,forceps would be in which class
Gamma biological indicators used to check sterility of batch after gamma irradiation would fall in which class
Please give rationale for selection of each class
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...
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.