The audit was carried out on 23 August 2022.
Objective
The objective of market surveillance is to monitor products covered by harmonised goods rules to ensure that only products that comply with applicable regulations are sold in the internal EU/EEA market.
Result
The audit identified four non-conformities concerning:
- Information in instructions for use
- Use of Norwegian language in instructions for use
- Safety information
- Declaration of conformity
Furthermore, we observed one improvement point concerning fundamental parameters.
What happens now?
We have asked IKM Instrutek AS to report by 5 December 2022 on how the non-conformities will be addressed and for their assessment of the improvement point observed.