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Medical Devices Directive


Understanding the Medical Devices Directive



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:


BSI Logos

Legal & Essential Requirements

Routes to Compliance

Post Market Surveillance

Manufacturing Standards