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  • dipanpatel replied to the topic Guidance Documents in the forum EU Regulatory Basics 7 years ago

    I believe the Guidance MEDDEVs is an important guideline. First and foremost they are drafted by the proper authorities that are in charge of being a safeguard for the public health, and guidelines that have that in mind will undoubtedly be useful to follow. As per my additional research, they can go through a consultation process with multiple parties are regularly updated. It is unusual to see a highly followed guideline not having a legal binding. But looking at the research, following these guidelines is very much expected by all interested parties. The guidelines range for many topics and provide multiply templets helpful for the devices.