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Class 1 Device Technical File

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Class 1 Medical Device

Class 1 medical device can be self-declared for CE compliance as per the MDR. Self-declaration means neither the Notified Body certification is required nor any other kind of approvals from any certification bodies!

 

Class 1 Medical Devices have the lowest risk perceived. In its case, the manufacturer can self-certify it.

Class 1 Medical Device

How to self-certify Class 1 Medical Device?

Following are the steps for affixing CE mark on Class I medical devices:

  • Technical Documentation preparation as per Annex II and III
  • Declaration of Conformity preparation as per Annex IV
  • Affixing the CE mark as per Annex V

For detailed information about each risk class1 and CE marking conformity assessment requirement, refer to individual pages.

Class 1s Medical Device (Sterile Medical Devices)

Class 1s medical devices have low/medium risks perceived. In this case of devices placed on the market in sterile condition, the Notified Body involvement is limited to the aspects of manufacture concerned with securing and maintaining sterile condition.

Class 1m (Measuring Devices)

Class 1m medical devices have low/medium risks perceived. In this case of devices placed on the market with a measuring function, the Notified Body involvement is limited to the aspects of manufacture concerned with the conformity of devices with the metrological requirements.

Class 1r Medical Device (Reusable Surgical Instruments)

Class 1r medical devices have low/medium risks perceived. In this case of reusable surgical instruments placed on the market, the Notified Body involvement is limited to the aspects relating to the re-use of the device in particular, cleaning, disinfection, sterilization, maintenance, and functional testing and related instructions for use.

CE Conformity Assessment Route

For Class 1s / 1m / 1r medical devices (inspection is limited to sterility/metrology/re-use as applicable), the conformity assessment route is as follows:

 

Technical Documentation (Technical File) preparation as per Annex II and III

Class 1 Medical Device 1

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

Steps for placing Class 1 Medical Devices on the EU market

  • Confirm product as a medical device
  • Confirm product as a class Is or 1m or Ir medical device
  • Confirm if the general safety and performance requirements have been met
  • Perform clinical evaluation
  • Prepare technical documentation
  • Request notified body involvement (For Class 1s, 1m & Ir)
  • Prepare instruction for use and labeling
  • Check compliance with general obligations for manufacturers as established in Article 10
  • The draw of the EU Declaration of Conformity
  • Affix the CE marking

Steps after placing Class 1 Medical devices on the EU market:

  1. Collect and evaluate Post Market Surveillance Data
  2. Vigilance system
  3. Non-conforming products -If a manufacturer finds that a device which they have placed on the market or put into service is not in conformity with the EU MDR, they will immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate.

Role of Consultants in Class 1 (s/m/r) CE Marking

It is a must to have experts on-board who have previous experience in Class 1s/1m/1r EU compliance and Clinical Evaluation for a successful outcome! Roles of I3CGOBAL are as follows:

  • Guidance and Technical File preparation
  • Identifies test requirements and reviews the external reports
  • Prepares Clinical Evaluation report as per Meddev 2.7/1 Rev 4.
  • Arranges Notified Body and coordinates with them till the issue of CE Certificate
  • Arranges EU Representative from the European Union
  • Arranges Free Sale Certificate from the European Union