The European Commission indeed works hard to provide further clarification on a number of aspect. Documents are being issued frequently now. It is great that long awaited clarification is being provided! However, stakeholder criticism is that some of the MDCG documents not only clarify aspects, but rather restate the requirements. Another fear is, that additional requirements are being introduced with the clarification instead of providing just the needed clarifications. These two aspects may become obvious when you would apply them. We certainly would appreciate feedback regarding this matter.
In any case, those documents, if they apply to your products or system, should be considered. For example the new software guidance is very important to support your classification for your software. That document was published last Friday 2019.10.11. mdcg_2019_11_guidance_qualification_classification_software.pdf
Europe | Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
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