Class 3 Medical Device

Class 3 Medical Device

Class 3 Medical Device CE Marking requirments are much more in MDR as per annexes II and III. This is where strict guidelines will come into play, mostly because these devices pose the greatest risk to the patient.

Most critical medical devices categorized under Class 3 /111/III as per MDR requirements. For Example All Class 3/III Medical Device manufactures has to undergo stringent performance and safety tests in addition to Clinical Evaluation as per latest Meddev guidelines compared to others..

Class 3 /111 Medical Device manufactures has to submit Technical Documentation / Technical File to the Notified Body for approval under Annex II and do not allow the Annex III / Annex VI option.

Definition & Examples for Class III Medical Device

Class 3/111 follows the same guidelines as Class 1s, Class 2a, Class 2b, but also has to have Notified Body design Examination and Technical Documentation / Technical File review before affixing CE Logo on your medical device.

Class III at times will be relied on to sustain human lives, so malfunctions are not acceptable in any manner.

Some examples would be pacemakers, cerebral simulators, and heart valves, medicated bandages etc.

Notified Body must carry out audit under Annex II full quality assurance system (EN ISO 13485:2016), plus that the manufacturer must submit the Technical File / Design Dossier to the Notified Body for approval under Annex II, for all type of Class III medical devices including medical devices with ancillary medicine.

(OR)

Type-examination (Annex 3) plus one of the two options given here:

  • Batch Inspection as per Annex IV

  • Audit of the production quality assurance system (Annex V) EN ISO 13485:2016 (with mandatory Design evaluation)

Details about Annex can be obtained from Medical Device Regulation-MDR.

Need help in Class III Medical Device Approval Process?

  • Technical Documentation covering the following,
  • Risk Analysis,
  • Clinical Evaluation,
  • Post Market Surveillance,
  • Post Market Clinical Follow Up,
  • IFU /User Manual review
  • Notified Body Technical Documentation /Technical File clearance.

More details about CE Certification Process click here .

We strongly support Class 3/III Medical Device manufactures with the following Services:

(a) Guidance on MDR Design Dossier / Technical File along with preparation.

(b) Identify Biocompatablity test requirements as per EN ISO 10993-1 and Identify the suitably accredited laboratory.

(c) Review the external Protocols and Reports.

(d) Conduct Clinical Evaluation and Prepare Clinical Evaluation Reports as per Meddev 2.7/1 Rev 4.

(e) Conduct Risk Analysis and prepare Risk Management File as per EN ISO 14971.

(f) Arrange Notified Body and Coordinate with them till the issue of CE Certificate.

(g) Arrange EU Representative from Europe.

(h) Arrange Free Sale Certificate from Europe.

(i) Development of Clinical Evaluation Report.

Class 3/III Certification Cost click here

 

We provide Medical Device Class 111/III/3 Regulatory Consulting services across the Globe. Few of the clients are from i:e: Canada, Germany, France, Egypt, India, UK (United Kingdom), USA (United States), UAE (United Arab Emirates), Australia, Dubai, Singapore, South Africa, many Europen countries.


Client Testimonial...


I 3 Consulting Reviewed by Mr. Manjunath Hegde on . Class III certification made easy! Thanks for help and support provided by members of I 3 Consulting. Rating: 4.9


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