Article 19 requires the manufacturer to draw up the EU DoC per Annex IV before placing the device on the market or putting it into service. By drawing up the EU DoC the manufacturer assumes responsibility for compliance. The EU DoC is kept available for 10 years (15 years for implantable devices). Article 20 requires affixing the CE marking visibly + legibly + indelibly on the device or its sterile pack and on instructions for use and on sales packaging. Where a notified body is involved, 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.