Webbased tool to analyze effect of significant changes to devices covered by MDD or AIMDD certificates

  • May 13, 2020
  • Posted by: confinis
  • Categories: confinis, Regulations
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The Swiss Notified Body SQS published a helpful tool on their website to analyze the effect of significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD: www.sqs.ch/de/mdr-assessment

Results can be submitted by email and may serve as documented evidence of the analysis.

It follows the respective MDCG 2020-3 guidance: ec.europa.eu/docsroom/documents/40301

 

Author: Beat U. Steffen (Founder & CEO)

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