R
Hi Fellows,
I see that MEDDEV 2. 4/1 does not deal specifically with accessories.
I have a class IIb device that is powered by a power supply which is a part of the basic kit.
Can I classify the power supply separately as a class I accessory (under rule 1 or perhaps rule 12) and include it in the declaration of conformity for the accessories which includes spare parts, carrying bag and such?
Appreciate your support!
BR,
Shimon
I see that MEDDEV 2. 4/1 does not deal specifically with accessories.
I have a class IIb device that is powered by a power supply which is a part of the basic kit.
Can I classify the power supply separately as a class I accessory (under rule 1 or perhaps rule 12) and include it in the declaration of conformity for the accessories which includes spare parts, carrying bag and such?
Appreciate your support!
BR,
Shimon
Hi all,
I am new in this forum but I might say I have learnt so many things. Thanks a lot for that!
Hereby, I have finally a question for you as well. I was checking quite much the available information however it is not clear to me what should be my next step hereafter. I would like to kindly ask you for a little bit of help regarding accessories for medical devices according to MDD (93/42). As far as I know already we should approve them with the NB with all necessary technical Doc and so to say to treat them as a medical device.
If I make the TD according to STED is that ok?
It is not exactly clear to me how we should label them? All of our Accessories will be Class I registered. Should they also have CE mark from the main medical devices or not at all.
I will be very happy if somebody can help me?
Thank in advance.
Best regards to all