Tag: MDR Class I

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As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?

Anonymous

updated about 1 year ago

We want to bring MDR class I software as a medical device to market. We’ve talked to other founders and checked out the list of MDR class I devices on this website and it seems that MDR class I softwa

Accepted answer

Yes, probably. Long Answer Some quick background information first! (By the way, if you're interested in a summary of MDR class I in general, check

MDR Class 1 Devices: Do They Exist (as software)?

Anonymous

updated about 1 year ago

I’ve heard that, under the MDR, software is usually classified as class IIa device or even higher. In the past, under the MDD, many software devices were classified only as class I. That made regulato

Accepted answer

Yes. Two examples come to mind: Software for the (primary) prevention of disease, and software for directly treating a disease. It boils down to readi

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

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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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Tag: MDR Class I

Articles

The MDR Class I Software Situation

No, Telemedicine Software Is Not Class IIa Under The MDR

MDR Class I: Everything You Need To Know

Questions

As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?

MDR Class 1 Devices: Do They Exist (as software)?

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

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Templates