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Tag: MDR Classification

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Dr. Oliver Eidel

No, Telemedicine Software Is Not Class IIa Under The MDR

Dr. Oliver Eidel
updated 9 months ago

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A

Should You Do a BfArM Classification Request? The Answer Is No.

Anonymous
updated about 1 year ago
We have no clue how to classify our medical device under the MDR. It could be class I, so we won’t have a notified body. Is there anyone who could give us a final decision? Our company is located in G
Dr. Oliver Eidel

Accepted answer

If you think your device is a MDR class I device, you have three options: • Just bring it to market and wait for a surprise audit by the (state) co

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