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  • CE Technical Documentation
  • Risk Assessment
  • Quality System ISO 13485


For European market access, medical devices must comply to the European Medical Devices Directive MDD 93/42/EEC, to ensure that they are safe and perform well. As a Notified Body for the MDD, ECM is designated to review the conformity of medical devices to the requirements of the MDD for access to the EU market. ECM can also provide ISO 13485 Quality Management System certification simultaneously with the MDD assessment.

The MDD certification process begins with the device risk classification, which determines the possible conformity assessment routes and whether a Notified Body certification is required.

Refer to the classification rules in Annex IX of the MDD to determine your device class:

  • Class I devices with low risk such as external patient support products
  • Class IIa/b devices with medium risk such as electro-medical devices
  • Class III devices with high risk such as cardiovascular catheters

All Class I-s, I-m, IIa, IIb, and Class III devices require Notified Body approval.

ECM is a Notified Body for I-s, I-m, IIa, IIb.

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