Europe - Nov 2019

December 4, 2019

  • EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels

  • EU: Industry expresses concerns about proposed Common Specifications for the reprocessing of single-use medical devices

  • EU: Proposal to update the Common Technical Specifications for certain types of assays

  • EU: MDCG publishes guidance on validity of certificates issued under Directives 90/385/EEC and 93/42/EC

  • EU: MDCG guide to the Summary of Safety and Clinical Performance is published

  • EU: MDCG guidance on qualification and classification of software under new Regulations

  • EU: MDCG updates Q&A on requirements relating to Notified Bodies

  • EU: Frequently asked questions about Europe’s new UDI system

  • EU: Guidelines released on the benefit-risk assessment of the presence of phthalates in certain medical devices

  • EU: EMA updates Q&A document to assist with implementation of Regulation (EU) 2017/745

  • Ireland: Significant fee increases/changes proposed for many medical device activities

  • UK: Medical device regulation and Brexit

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Click here for the full article on Global Regulatory Press.
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