Article 17 requires the manufacturer to draw up the EU declaration of conformity (DoC) before placing the IVD on the market or putting it into service. The DoC contains the Article 17(1) information set out in Annex IV. By drawing up the DoC the manufacturer assumes responsibility for compliance. The DoC is kept available for the competent authority for 10 years. Article 18 requires affixing the CE marking visibly + legibly + indelibly on the device or its sterile pack and on the instructions for use and on the sales packaging. Where a notified body is involved (per Article 48 + Article 49) the NB identification number follows the CE marking.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.