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MDR classification of medical devices – are you aware of your obligations?
The correct classification of medical devices according to the MDR (EU 2017/745) is the first and crucial step on the way to CE marking – and thus to market approval in Europe. However, many manufacturers have difficulties with this step.
- What rules apply to your software as a medical device?
- How do you avoid errors in the crucial intended purpose?
- What impact does, for example, ‘Rule 11’ have on your medical software?
Example of the much-discussed ‘Rule 11’, MDR
De often difficult determination of the intended purpose shows that your software can be classified in class 1. This means that the conformity assessment and CE marking could be carried out without a notified body. The result: it becomes easier and cheaper!
We can help you to see more clearly!
In our 1- to 3-day workshops – individually tailored to your products and issues – we analyse the classification rules together, discuss the requirements and define a sound regulatory strategy.
Your advantage
You save time, avoid costly mistakes – and get CE marking faster.
Conclusion
A correct classification of your product is the basis for a successful authorisation. Use our expertise before it gets expensive.
Request a workshop and get MDR-ready!
Our specialist Dilek Imre (info@sinovo.de) will be happy to advise you and organise a suitable workshop for you!
