How to register class IIA medical device accessories

Son of Paperman

Starting to get Involved
#1
Our company designs, manufactures and distributes dental implants and the accessories for their placement.

We grouped our products for registration, and one of those groups contains only accessories that have the shared intended use "Transient reference point for the production of prostheses or attachment constructions.".
We have established their class as being IIa because they are either:
1) Invasive, reusable, transient use, goes through body orifice, does penetrate skin, not connected to class I active device => annex VIII, rule 6. or​
2) Accessory to a device that is invasive, reusable, goes through body orifice, does not penetrate skin, not connected to class I active device => annex VIII, rule 5.3.​
We consider these accessories not to be medical devices because they do not "alleviate or compensate an injury or disability" nor do they "replace or modify the anatomy" (article 2 definition 1). They only are temporary assistance.

So my questions:
- can you register accessories on their own or can only medical devices be registered?​
- can the standard registration procedure be used or is an alternative route required?​
Thank you in advance for your assistance.
 
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Ronen E

Problem Solver
Moderator
#2
In the EU accessories to medical devices are regulated just like medical devices (same requirements and procedures apply, unless explicitly stated otherwise).

I'm currently not going into the question of whether or not classification as accessories (rather than devices) is correct in this case.
 
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