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Medical Devices Directive

 

Understanding the Medical Devices Directive

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The Medical Devices Directive 93/42/EEC, as amended by 2007/47/EC, is the most demanding of regulations that Robinson Healthcare must comply with in order to legally market and sell the wide range of medical products that it manufactures. 

 

This section of the website provides an overview of the Directive, how Robinson Healthcare determines which Class each product belongs to and the regulatory framework which has to be followed to gain compliance. This has been broken down into the following areas of the Directive:

 

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FM12010

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MD514840

Legal & Essential Requirements


Routes to Compliance


Post Market Surveillance


Manufacturing Standards


Certification