medical device ce marking

Medical Device CE Marking & Approval Services


Medical Device CE Marking is a mark which shows the medical devices 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 EU MDR Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 are the two new regulation.

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 as per MDR

The definition of medical device CE Marking is provided in MDR 2017/745, Article 2. The following devices fall article 2 definition for example:.

  • General use medical devices (Sterile and Non-Sterile)
  • Active Medical Devices
  • Non-Active medical device
  • Implantable Medical Devices
  • Medical equipment and machinery
  • Home Healthcare Devices
  • Software as Medical Devices (SAMD)
  • Active Implantable Medical Devices

Medical Device CE Marking Process

Planning for CE marking for a medical device. Below are the important steps to be followed:

  1. Identify the device risk classification and route for CE marking.
  2. Identity the product-specific and harmonized standards.
  3. Implement medical device quality management system (EN ISO 13845)
  4. Complete design & development activities
  5. Conduct risk analysis as per iso 14971
  6. Complete verification and validation.
  7. Conduct electrical safety and biological safety testing.
  8. Complete manufacturing environmental studies.
  9. 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 the suitable notified body.
  15. Submit a technical file to the notified body.
  16. Ready for the onsite QMS audit. (ISO 13485).
  17. Answer and update technical file as per nb review comments.
  18. Close all finds from the onsite audit.
  19. Approve the draft certificate.
  20. Affix CE Logo on the medical device.

In-Vitro Diagnostic Devices CE Marking as per IVDR

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 fall 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 Process

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

  1. Identify the IVD Risk Class (A, B, C or D).
  2. Identify the product-specific and harmonized standards.
  3. Implement medical device quality management system ( EN ISO 13845).
  4. Conduct Risk analysis as per ISO 14971.
  5. Complete performance evaluation plan.
  6. Conducts device performance and efficiency studies.
  7. Complete shelf life and stability studies.
  8. Complete proactive post-market performance follow-up (PMPF).
  9. Conduct batch testing.
  10. Complete technical documentation / technical File.
  11. Non-European Manufactures must appoint a European Authorized Representative.
  12. Identify suitable notified body.
  13. Submit a technical file to notified body
  14. Ready for onsite QMS (ISO 13485) audit.
  15. Answer and update the technical file as per NB review comments.
  16. Close all finds from the onsite audit.
  17. Approve the draft certificate.
  18. Affix CE Logo on In Vitro diagnostic device.


For a detailed quote about CE marking for medical device or approval services, please fill the Request for Quote [RFQ] and submit online.

 

We are Medical Device CE Marking & Vitro Diagnostic Device Consultants providing services across the Globe from the year 1999. Our clients are from various counties and cities.

1. USA (New York, Los Angeles, Chicago, Houston, San Antonio, San Diego, Dallas, Boston, and Miami), 2. UK (London, Birmingham, Manchester, Liverpool, Newcastle, Sheffield) 3. Germany (Berlin, Hamburg, Munich, Cologne, Dusseldorf) 4. India (New Delhi, Bangalore, Mumbai, Chennai, Pune, Ahmedabad, Kochi, Hyderabad, Kolkatta, Coimbatore) 5. UAE 6. France 7. Netherland 8. Australia 9. South Africa 10. Spain 11. Norway 12. Mexico 13. Canada 14. Malaysia 15. Singapore 16. South Korea 17. Egypt.

Recent Client Testimonial.


EMC Medical BV Reviewed by Sam James in . Wonderful Team!!!. They are very good. I am glad to recommend I 3 CONSULTING to others looking for CE Marking support. Rating: 4.9

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