Europe - Nov/Dec 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. Contact us at


Recent Posts

See All

Europe - May 2020

Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by one year EU: Continued use of lead as a thermal stabiliser in P

EU: MDR delayed to 26 May 2021

Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in getting essential medical devices needed to combat Covid-19. The

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle
  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle



Call us:

   : +65 6909 0396

   : +65 9067 1432


Email us:


© 2020 ARQon All Rights Reserved. 

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle