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Essential Requirements Checklist Template - UKCA Marking

Essential Requirements Checklist Template - UKCA Marking

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ISO 13485 - QMS.4.2.3.1.4 - Essential Requirements Checklist Template - UKCA Marking

The Essential Requirements (ER) checklist is a checklist against annex I of 93/42/EEC used to demonstrate conformity with the UK Medical Device Regulations 2002 for the purposes of medical device UKCA marking. The device needs to be assessed against each clause of annex I, and evidence presented on how the requirements have been met and where the evidence is located, or a justification as to why the requirement is not applicable, just writing not applicable is not sufficient. This template provides a full list of annex I clauses and formatted to easily present the data required to demonstrate conformity.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

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