For a medical device manufacturer to self-certify EU conformity for a Class I cannabis oil vaporizer, the following documents must be prepared and made available to demonstrate compliance with the Medical Devices Regulation (MDR) 2017/745:

1. Technical Documentation:
   • A comprehensive set of documents that demonstrate the device’s design, manufacture, and performance, including:
     • Device description and specifications.
     • Intended purpose and indications for use.
     • Design drawings, diagrams, and schematics.
     • Manufacturing processes and quality control measures.
     • Risk management documentation (ISO 14971 compliance).
     • Software validation (if applicable).
     • Biocompatibility testing (if the device comes into contact with the body).
     • Performance testing and verification (e.g., safety, functionality, and usability).
2. Declaration of Conformity (DoC):
   • A signed document declaring that the device complies with the MDR and any other applicable EU legislation.
3. Unique Device Identification (UDI):
   • Implementation of the UDI system, including the assignment of a UDI-DI and UDI-PI to the device.
4. Labeling and Instructions for Use (IFU):
   • Labels and IFU must comply with MDR requirements, including:
     • Device identification.
     • Manufacturer details.
     • Intended use.
     • Safety information.
     • CE marking.
5. Clinical Evaluation Report (CER):
   • A report demonstrating the device’s clinical safety and performance, based on a review of relevant clinical data.
6. Post-Market Surveillance (PMS):
   • A PMS plan and system to monitor the device’s performance and safety after it is placed on the market.
   • Periodic Safety Update Reports (PSURs) for Class I devices (if required).
7. Quality Management System (QMS):
   • Evidence of a QMS in place, compliant with ISO 13485 or equivalent, covering design, production, and post-market activities.
8. CE Marking:
   • Affix the CE mark to the device, packaging, and IFU to indicate compliance with the MDR.
9. Person Responsible for Regulatory Compliance (PRRC):
   • Documentation identifying the PRRC within the organization, as required by the MDR.
10. Registration with EUDAMED:
    • Register the device and manufacturer in the European Database on Medical Devices (EUDAMED) once it is fully operational.
11. Harmonized Standards:
    • List of harmonized standards applied to demonstrate compliance with the MDR (e.g., EN ISO 10993 for biocompatibility).
12. Vaporizer-Specific Requirements:
    • If the cannabis oil vaporizer has specific regulatory requirements (e.g., related to emissions or materials), ensure compliance with relevant standards and regulations.

These documents must be kept up to date and made available to competent authorities upon request. Note that while Class I devices generally do not require involvement from a Notified Body, certain Class I devices with higher risks (e.g., sterile or measuring function) may require Notified Body intervention. Ensure the device is correctly classified under the MDR.