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
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