Medical device regulatory conformity and compliance in the UK and EU post-Brexit

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Medical device manufacturers are becoming increasingly familiar with managing regulatory changes. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR). However, for those hoping for time to relax after completing their transition to the MDR and IVDR, the UK has other plans!

While the detail of the UK’s future regulatory regime is yet to be determined there is an urgent need to understand the overlap between EU MDR and IVDR preparation and the emerging UK framework. This understanding will eliminate unnecessary duplication of effort and will help medical device manufacturers as they set their strategy and make important product portfolio decisions regarding the UK and EU markets.

THIS Guide COVERS:

  • Summary of the known requirements of the new UK regime
  • Highlight of top priority areas for attention
  • Identify where detail may still be emerging

To access you free copy of the “10 Steps to Prepare for UK Conformity Assessment” Brexit Guide please fill out the form on the page.

 

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“Together you all moved the mountain. I am greatly appreciative and humbled by all of your commitment to excellence. Thank you for all you have done for [our company].”

MDR submissions senior manager

Large multinational medical device manufacturer