We use other medical device in combination with our device (accessory to our medical device)... Should our technical file (STED) include all biocompatibility and sterilization validations from that "of the shelf" medical device or the declaration of conformity should be sufficient?
Medical devices as an accessory from another manufacturer
- Thread starter med_cert
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dgrainger
Trusted Information Resource
The definition of an 'accessory to a medical device' makes it clear that it cannot be a device in it's own right.
If you are making claims about the combination you need to ensure that the combination is safe. Can you demonstrate safety just by relying on the declaration of conformity?
If you are making claims about the combination you need to ensure that the combination is safe. Can you demonstrate safety just by relying on the declaration of conformity?
The safety of combination of our and other device is ensured by our verification in development phase.
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