(1) Identity of the device
The manufacturer should identify the device, and where applicable the various configurations / variants covered by the checklist.
(2) Applicable to the device?
Is the listed Essential Principle applicable to the device? Here the answer is either ‘YES’ or ‘NO’. If the answer is ‘NO’ this should be explained briefly in the ‘method used to demonstrate conformity’ column.
Example: For a device that does not incorporate biological substances, the answer to Essential Principle 5.8.2 would be ‘NO’ and, in the ‘method used to demonstrate conformity’ column, would include an explanation such as ‘The device does not incorporate biological substances.’
(3) Method used to demonstrate conformity
In this column the manufacturer should state the type(s) of method(s) that they have chosen to use to demonstrate conformity e.g. the recognised standard(s), industry or in-house test method(s), comparison study(ies) or other method used.
(4) Method reference
After having stated the method in the previous column, here the manufacturer should now name the title and reference of the recognised standard(s), industry or in-house test method(s), comparison study(ies) or other method used to demonstrate conformity. For standards, this should include the date of the standard and where appropriate, the clause(s) that demonstrates conformity with the relevant EP.
(5) Reference to supporting controlled documents
This column should contain the reference to the actual technical documentation that demonstrates conformity to the essential principle, i.e. the certificates, test reports, validation reports, study reports or other documents that resulted from the method used to demonstrate conformity and its location within the STED.