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Declaration of conformity templates (IVDs)

11 December 2020

As part of the conformity assessment procedures, the manufacturer of an IVD medical device is required to make a Declaration of Conformity which declares that the device complies with:

  • the applicable provisions of the Essential Principles
  • the classification rules
  • an appropriate conformity assessment procedure

The declaration also requires the manufacturer to provide details that are relevant to the conformity assessment procedure and the manufacture of the IVD medical device covered by the declaration.

It should be noted that these templates are published to assist in the preparation of declarations of conformity. It is the responsibility of the manufacturer signing a declaration to ensure that it is drawn up correctly and meets all the legal requirements.

Clause 6B.6

How to access an rtf or Word document

Clause 1.8

Clause 4.7

Clause 6.6

Clause 7.5