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Class IIb Medical Device

Class IIb Medical Device constitutes medium to high-risk devices such as incubators for babies, intraocular lens, orthopedic 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.

Class 2b Rule 12 Medical Devices CE Marking Conformity Assessment Route

Class IIb Medical Device 1

Followed by the above-given assessment methods, class 2b 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 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:

Class IIb Medical Device 2

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

CLASS IIb Implantable Excluding WET* Devices CE Marking Conformity Assessment Route

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

Class IIb Medical Device 3

  • 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

Roles of I3CGLOBAL are as follows:

 

  • Guidance and Technical File preparation
  • Identifies Biocompatibility test requirements and reviews the external Protocols and Reports.
  • Prepares Clinical Evaluation Report as per Meddev 2.7/1 Rev 4
  • Conducts Risk Analysis and prepares Risk Management File as per EN ISO 14971
  • Arranges Notified Body and coordinates with them till the issue of CE Certificate
  • Arranges EU Representative from European Union
  • Prepares Periodic Safety Update Report (PSUR), PMS plan and PMCF plan and report
  • Arranges Free Sale Certificate from European Union