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    Class 1 Device Technical File

    Check the fees and timeline for Technical File preparation and Testing

    What is a Class I Medical Device?

    Class 1 Medical Device can be self-declared for CE compliance as per the MDR. Self-declaration means neither the Notified Body certification is required nor any other kind of approvals from any certification bodies! Class 1 have the lowest risk perceived. In its case, the manufacturer can self-certify it.

    Class 1 Medical Device

    How to self-certify Class 1 Medical Device?

    Following are the steps for affixing CE mark on Class I medical devices:

    • Affixing the CE mark as per Annex V
    • Technical Documentation preparation as per Annex II and III
    • Declaration of Conformity preparation as per Annex IV

    For detailed information about each risk Class 1 and CE marking conformity assessment requirement, refer to individual pages.

    Sterile Medical Devices

    Class 1s medical devices have low/medium risks perceived. In this case of devices placed on the market in sterile condition, the Notified Body involvement is limited to the aspects of manufacture concerned with securing and maintaining sterile condition.

    Measuring Devices

    Class 1m medical devices have low/medium risks perceived. In this case of devices placed on the market with a measuring function, the Notified Body involvement is limited to the aspects of manufacture concerned with the conformity of devices with the metrological requirements.

    Reusable Surgical Instruments

    Class 1r medical devices have low/medium risks perceived. In this case of reusable surgical instruments placed on the market, the Notified Body involvement is limited to the aspects relating to the re-use of the device in particular, cleaning, disinfection, sterilization, maintenance, and functional testing and related instructions for use.

    CE Conformity Assessment Route

    For Class 1s / 1m / 1r medical devices (inspection is limited to sterility/metrology/re-use as applicable), the conformity assessment route is as follows:

    Technical Documentation (Technical File) preparation as per Annex II and III

    • Declaration of Conformity as per Annex IV
    • Affixing the CE mark as per Annex V

    Steps for placing Class 1 Medical Device on the EU market

    • Confirm product as a medical device
    • Confirm product as a class 1s or 1m or 1r medical device
    • Confirm if the general safety and performance requirements have been met
    • Perform clinical evaluation
    • Prepare technical documentation
    • Request notified body involvement (For Class 1s, 1m & Ir)
    • Prepare instruction for use and labeling
    • Check compliance with general obligations for manufacturers as established in Article 10
    • The draw of the EU Declaration of Conformity
    • Affix the CE marking

    Steps after placing Class 1 Medical Device on the EU market:

    1. Collect and evaluate Post Market Surveillance Data
    2. Vigilance system
    3. Non-conforming products -If a manufacturer finds that a device which they have placed on the market or put into service is not in conformity with the EU MDR, they will immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate.

    Role of Consultants in Class 1 Medical Device (s/m/r) CE Marking

    It is a must to have experts on-board who have previous experience in Class 1s/1m/1r EU compliance and Clinical Evaluation for a successful outcome! Roles of I3CGOBAL are as follows:

    • Guidance and Technical File preparation
    • Identifies test requirements and reviews the external reports
    • Prepares Clinical Evaluation report as per Meddev 2.7/1 Rev 4.
    • Arranges Notified Body and coordinates with them till the issue of CE Certificate
    • Arranges EU Representative from the European Union
    • Arranges Free Sale Certificate from the European Union