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HARMONIZED Standards as per MDD

Harmonized standards are European Norms (EN) that are elaborated by the European standardization bodies (CEN, CENELEC, ETSI) under a mandate from the European Commission. The Commission specifies certain essential requirements within a given directive that have to be set out in greater detail.

The use of standards is voluntary, except in those cases where certain standards have been deemed mandatory by the Regulatory Authority. Manufacturers should be free to select alternative solutions to demonstrate their medical device meets the relevant Essential Principle. Manufacturers may use "non-recognised" standards, in whole or in part, or other methods.

The manufacturer should retain or can provide documentation to demonstrate that the Medical Device complies with the selected standard or alternative means of meeting the Essential Principles in the Medical Device Technical File. Technical File / Design Dossier Documentation MUST include a list of applicable Harmonized standards and Non applicable International Standards.

When a standard is not applied, or is not applied in full, the manufacturer should retain, and submit where appropriate, data or information to demonstrate

We can help you with testing of medical device as per harmonized standards. More details refer Medical Device Testing.

LMG can also assist you with

  • Medical Device Classification
  • Identification of MDD requirements
  • Identification of Harmonized standards
  • ISO 13485 Implementation
  • Identification of Notified Body
  • Technical File preparation
  • Technical File submission to Notified Body
  • Technical file re-submission
  • Assistance with Notified Body audit
  • Assistance in closing non-conformities
  • Affix CE Mark

 
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