Surgical Instrument Tray Classification

#1
Hi,

I was hoping to get some help on a classification query I have. We sell instrument trays used to hold the instruments during reprocessing and Sterilisation. I’m not sure whether they should be classified under MDR as a Class I or Ir or ClassIIA. Any opinions/advice?

Thanks in advance s-l500.jpg
 
Last edited:
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planB

Super Moderator
#2
drwallice,

classification depends on your defined intended use: if your instrument tray is intended to just _hold_ the instruments in place during reprocessing, then your tray is class Ir. If you claim that your tray is "intended specifically to be used for disinfecting or sterilising medical devices" (quote from Rule 16), then your tray would be class IIa. Typically, an instrument tray is classified as 1r device.

HTH,
 

RosaB

Registered
#4
Hello,
thank you planB for your answer. May I ask though, why a tray is supposed to be class Ir, if this class is intended for reusable surgical instruments? A tray is definetely not a reusable surgical instruments, as thos are defined as follows: "‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out."

I agree though on the classification in class IIa if Rule 16 applies. As I have the same problem as drwallice, I would classify it as an accessory of class I. Would you two agree?

Thanks!
 

Asia78

Involved In Discussions
#5
Hi, they are definitely not.class ir because they are not surgical devices.
They are also not following rule 16 because they do not act as disinfectant ( art 16 is.followed by other type of devices).
I would classify them as class I, rule 1
 
#7
Accessories for a medical device shall be classified in their own right separately from the device with which they are used. Chapter II 3.2
 

Asia78

Involved In Discussions
#8
Accessories for a medical device shall be classified in their own right separately from the device with which they are used. Chapter II 3.2
Exactly.
The accessory take the same class if it is driving or influencing the performance of a (hardware) medical device
 
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