Class III medical devices CE Marking procedures

CE Marking Approval for Medical Devices , Guidelines for Classification of Medical Devices

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CE Marking for Medical Devices, CE Mark, requirements, certification, approval, testing, European directives, and standards

If you are looking for CE Marking Certification for Medical Devices, If you want to sell your medical device/Products in European countries you will need a CE Marking Certificate on the Medical products to show it complies with European health, safety & environmental protection legislation. If you’re looking for a CE Mark Consultant to help you achieve a CE Certification, look no further than that.                                                             

Our Certification Body provides comprehensive testing and certification services, guiding you through every step of the CE Marking process for medical devices in India.
In order for your products to be placed in European countries, they must meet the requirements of the relevant product/Device directives. We help you understand and meet these directives to ensure your product completes the CE Mark Certification process efficiently & successfully.

Before the CE Mark may be affixed to a medical device or Medical Products & legally sold within the European Union, the manufacturer/Exporters/Suppliers must complete the following Guidelines:

  • (Technical File) Prepare for Technical Documentation to show the product’s compliance with applicable essential requirements & conformity assessment procedures of the applicable device directive
  • Register their Medical device with the appropriate Competent Authorities
  • Receive a Medical device-specific CE Certificate from a Notified Body (Class I devices do not require a certificate from a Notified Body)

8 Steps to Get CE Marking for Medical Devices in India:

Navigating the CE Mark Certification process does not have to be painstaking. In fact, we makes it as easy as the following steps:

1. Classify your product – Class I, IIa, IIb, and III according to the classification rules in Annex IX of the Medical Devices Directive 93/42/EEC MDD:

  • Class I. Medical Devices with low risk such as external patient support products.
  • Class IIa/b. Medical Devices with medium risk such as electro-medical devices.
  • Class III. Medical Devices with high risk such as cardiovascular catheters.
  • Some Class I and all Class IIa, IIb, and Class III Medical devices require Notified Body approval.

2. Determine your certification process based on your device class

3. Fulfill the essential requirements – Ensure that your medical device fulfills the essential requirements in Annex I of the Medical Device Directive MDD.

4. Establish a monitoring system – As a manufacturer, you are required to monitor your products once they are on the market, in case accidents involving your products occur.

5. Establish an accident reporting system – If an accident or near-accident involving any of your products takes place, you are obligated to report this to the authorities.

6. Issue a Declaration of Conformity

7. Save the documentation for five years – The new revision of the MDD Medical Devices Directive 93/42/EEC requires that records for implantable devices be kept for 15 years. Declaration of conformity, technical documentation, reports, and certificates from the Notified Body, etc. must be kept for at least five years after the product has been taken out of production.

8. Register with the appropriate authorities in Europe

CE Marking in India – Entry to European Market | Get a quote for Testing to support CE Marking.

Contact Now! Mr. Puneet Sharma
M: 08196980555 E: CE.Marking.Certification@Gmail.Com

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