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    Class iib Medical Device

    Class iib Medical Device constitutes medium to high-risk devices such as incubators for babies, intraocular lenses, orthopaedic nails, and plates, etc. For Class iib Medical Device, the declaration of conformity is backed up by notified body assessment, and sometimes clinical evaluation consultation procedure depending on the type of device.

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    Class iib Medical Device Rule 12 CE Marking Conformity Assessment Route

    Followed by the above-given assessment methods, Class iib Medical Devices falling under rule 12 must run through:

    • Clinical Evaluation Consultation Procedure as per Annex IX sec. 5/Annex X sec. 6
    • Declaration of Conformity as per Annex IV
    • Affixing the CE mark as per Annex V CE marking

    Class iib excluding rule 12 CE Conformity Assessment Route

    Class iib Implantable WET* Medical Devices, Class IIb Non-implantable (non-rule 12, non-WET) CE marking Conformity Assessment Route

     

    *Well-Established Technologies (WET) – sutures, staples, dental fillings and braces, tooth crowns, screws, wedges, plates, wires, pins, clips & connectors as per Article 52 of MDR.

    The CE mark conformity assessment route is as follows:

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

    Class IIb Implantable Device CE Conformity Assessment Route

    For Class iib Implantable Devices (Excluding WET), the CE mark conformity assessment route is as follows:

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

    For detailed information about each risk class and CE mark conformity assessment requirement, refer individual pages.

    Class IIb Medical Device & Role of Consultants

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