(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and clinical evidence; (d) comparison to a similar device already available on the market. (iii) The essential principles checklist should incorporate a cross-reference to the location of such evidence both within the full technical documentation held by the manufacturer and within the dossier. A template for a checklist is shown in as under:— Essential Principle Relevant Yes/No Specification!standard Subclause!reference Complies Yes /No Document Reference Justification and/or comments 6.0 Risk analysis and control summary: The dossier should contain a summary of the risks identified during the risk analysis process and how these risks have been controlled to an acceptable level. This risk analysis should be based on prescribed standards and be part of the manufacturer's risk management plan based on complexity and risk class of the device. The technique used to analyse the risk must be specified, to ensure that it is appropriate for the medical device and risk involved. The risks and benefits associated with the use of the medical device should be described. The risk analysis submitted shall have periodic updation of the risks identified as per risk management plan.