MDR - annex X - article 1

Original text

Expert opinion

Conformity assessment based on type-examination

1. EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentation and relevant life cycle processes and a corresponding representative sample of the device production envisaged, fulfils the relevant provisions of this Regulation.



By this approach, i.e. the type examination, a Notified Body (NB) certifies that the product and its documentation is compliant to the regulation MDR 2017/745.

Obviously, the NB will examine a sample or samples of the product to be certified along to the technical documentation and process documentation.

The manufacturer has to agree with the NB on the testing lab. Applicable standards will be reviewed by the NB and applicable tests thereof will be carried out on the product in the agreed lab.


An EU type-examination report on the results of the assessments and tests carried out will be provided by the NB.

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