Question on MDR classification

#1
We are a US based dental instrument manufacturer. We manufacture forceps, scissors, needle holders. Does this mean we are all Class 1r for the MDR? Is there any piece we can self certify?
 
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chris1price

Trusted Information Resource
#4
They appear to be surgical instruments, are they reusable? If they are, then they are class 1r.

Are the supplied sterile? If they are, then they are also class 1s.

If they are not reusable, and not sterile, then class 1 (self-certify).
 

KShaw

Starting to get Involved
#5
Hi Karena,

Just to add to the great replies above, the MDR defines a reusable surgical instrument as (Annex VIII 2.3):
‘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.

The devices you've mentioned seem to fall into this category and would thus require NB-intervention. Keep in mind that if you have these currently registered under the MDD, you can benefit from the transitional provisions in Article 120(3) and have till 2024 to comply with the MDR (terms and conditions apply - see Article 120(3)).

Best of luck,
Kenneth
 
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