Classification of reusable orthopedic instruments used to fit implants

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/