Medical Device Classification Class III

Class III Medical Device

Most critical medical devices based on MDD are categorized under Class III. All Class III Medical Device manufactures has to undergo stringent performance and safety tests in addition to Clinical Evaluation as per latest Meddev guidlines compared to others. Class III Medical Device manufactures has to submit the Design Dossier to the Notified Body for approval under Annex II and do not allow the Annex III/Annex VI option.

Explaining Class III Medical Devices

A Class III Medical Device are very complicated in design and usage. This is where strict guidelines will come into play, mostly because these devices pose the greatest risk to patient. Class III follows the same guidelines as Class Is, Class IIa, Class IIb, but also has to have Notified Body design Examination and Design Dossier / Technical File review before affixing CE Logo on your medical device. Class III Medical Devices at times will be relied on to sustain human lives, so malfunctions are not acceptable in a 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 ancilary medicin.
(OR)
Type-examination (Annex III) 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)

Visit EU Website for more details about Medical device directive.

Need help in Class III Medical Device Design Dossier / Technical File prepration? We can help you with complete support starting from scoping, Drafting, Risk Analysis, Clinical Evaluation, Post Market Survilance, Post Market Clnical Follow Up, IFU review and follow up with Notified Body till Design Dossier clereance.

We support class III Medical Device manufactures with the following Services

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

(b) Identify Biocompatablity test requirments as per EN ISO 10993-1 and Identify teh suitable accredated laboratory.

(c) Review the external Protocols and Reports.

(d) Conduct Clinical Evaluation and Prepare Clinicial 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 issue of CE Certificate.

(g) Arrange EU Representative from Europe.

(h) Arrange Free Sale Certificate from Europe.

Contact us to discuss your needs and how we can help. You can drop us an Email to enquiry@i3cglobal.com or call nearest location.

INDIA – Bangalore
+ 91 994 591 2081
Phone / WhatsApp


USA – Chicago
+1 630 696 1293
Phone / WhatsApp


GERMANY – Bremen
+49 2161 990 8831
Phone / WhatsApp


mail enquiry@i3cglobal.com
LiveZilla Live Chat Software