Medical Device CE Marking

CE Marking of Medical Devices


CE Marking of Medical Devices is a mark which shows the medical device is in conformity with health, safety, and environmental protection standards and sold within 28 EU Member countries, EFTA/EEA countries covering Norway, Liechtenstein, Iceland, Turkey & Switzerland.

Medical Device Regulation EU MDR Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 are the two new regulation on medical device.

CE Marking logo affixed on the medical device indicates the device fulfills the quality requirements and harmonized standards.

It is the responsibility of the Medical Device manufacturers or distributors to make sure device sold in the above countries must comply with the Medical Device Regulation (MDR) before affixing CE Marking and placing them on the European Market. Failure to do so can result in sanctions such as removal of products from sale or use and in some cases prosecution..


Medical Device CE Marking Definition

The definition of medical device CE Marking is provided in MDR 2017/745, Article 2.

The following devices falls article 2 definition for example.

CE Marking of Medical Devices Process


Planning for Medical Device CE Marking. Below are the important steps to be followed.

01: Identify the Device Risk Classification and Route for CE Marking

02: Identify the Product Specific and Harmonized Standards.

03: Implement Medical Device Quality Management System ( EN ISO 13845)

04: Complete Design & Development Activities

05: Conduct Risk Analysis as per ISO 14971

06: Complete Verification and Validation.

07: Conduct Electrical Safety and Biological Safety Testing.

08: Complete manufacturing Environmental Studies.

09: Conducts device performance studies.

10: Complete Shelf Life and Stability Studies.

11: Complete Transportation and Packaging Validations.

12: Complete Clinical Evaluation and Post Market surveillance.

13: Complete Technical Documentation / Technical File.

14: Identify Suitable Notified Body.

15: Submit Technical File to Notified Body.

16: Ready for onsite QMS (ISO 13485)

Audit.

17: Answer and Update Technical File as per NB review comments.

18: Close all finding from Onsite Audit.

19: Approve the Draft Certificate.

20: Affix CE Logo on medical Device.

In Vitro Diagnostic Devices CE Marking

The definition of In Vitro Diagnostic Devices and accessories for In Vitro Diagnostic Devices are provided in MDR 2017/746, article 2.

The following devices falls article 2 definition for example.

  • General purpose laboratory Reagents and products

  • Calibrator

  • Kit.

  • Control Material and Reagent

  • Instrument or Apparatus.

  • Software or System

In Vitro Diagnostic Devices CE Marking of Medical Devices Process

Planning for Medical Device CE Marking of In Vitro Diagnostic Medical Device. Below are the important steps to be followed.

01: Identify the IVD Risk Class (A,B,C or D)
02: Identify the Product Specific and Harmonized Standards.
03: Implement Medical Device Quality Management System ( EN ISO 13845).
04: Conduct Risk Analysis as per ISO 14971.
05: Complete performance evaluation plan .
06: Conducts device performance and efficiency studies.
07: Complete Shelf Life and Stability Studies.
08: Complete proactive Post-Market Performance Follow-up (PMPF).
09. Conduct batch Testing.
10: Complete Technical Documentation / Technical File.
11. Non-European Manufactures must appoint European Authorized Representative.
12: Identify Suitable Notified Body.
13: Submit Technical File to Notified Body.
14: Ready for onsite QMS (ISO 13485) Audit.
15: Answer and Update Technical File as per NB review comments.
16: Close all finding from Onsite Audit.
17: Approve the Draft Certificate.
18: Affix CE Logo on In Vitro Diagnostic Device.

If you need help with In Vitro Diagnostic Device CE marking, please contact us.

MDR 2017/745 PDF file for Download.

IVDR 2017/746 PDF file for Download.

CE Marking of Medical Device Process Flow Chart which explains the complete process.

Medical Device CE Marking Fees / Cost click here

For a detailed quote, please fill the Request for Quote [RFQ] and submit online.

 

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