![]() You need to decide if your product is a medical device before you go through the compliance process.Īccording to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), a medical device is described as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of: ![]() For information on how to comply with the legal requirements in Northern Ireland, please see our guidance on Northern Ireland. This guidance is specific to the provisions in Great Britain (England, Wales and Scotland). This guidance outlines the steps you need to follow before your product can be placed on the Great Britain market with a UKCA mark.
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