To maintain a valid CE Mark under Annex II, what should the manufacturer do?

To maintain a valid CE mark under Annex II, manufacturers are required to actively manage their technical documentation throughout the validity period of the certification. The correct approach involves collecting all relevant new information and compiling it to update technical files for audit and review by the notified body (NB) as required during the five-year period following CE marking.

This process ensures that manufacturers stay compliant with evolving regulations and standards, as well as any new safety or performance data that might affect their products. By updating technical documentation regularly within this timeframe, manufacturers are demonstrating their commitment to product safety and efficacy, which is crucial for maintaining their market access in the European Economic Area (EEA).

The other options suggest either insufficient frequency of updates or a lack of required compilations, which would not meet the regulatory expectations outlined in Annex II. Regular audits and reviews by the notified body are essential to confirm ongoing compliance and safety, hence the choice highlighting updates during the defined five-year period is the most aligned with regulatory obligations.