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class IIb medical device

Class IIb Medical Device

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

Class IIb Medical Device Conformity Assessment

Class IIb Medical Device 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 marking 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 for medical devices 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 11b medical device

  • 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 medical devices (Excluding WET), the CE mark conformity assessment route is as follows:

class IIb medical device

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

Class IIb Medical Device Consultants Responsibilities

  • 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 European Authorized Representative from EU
  • Prepares Periodic Safety Update Report (PSUR), PMS plan and PMCF plan and report
  • Arranges Free Sale Certificate from European Union
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