2022 Outlook – Updates for Europe’s Regulatory Landscape: Recent Changes in the EU, United Kingdom and Switzerland

2021 Marked the Medical Devices Regulation (MDR) date of application, new dates for the In Vitro Diagnostics Regulation (IVDR) implementation and a host of other changes for the European Union. In addition, regulators in the U.K. published new requirements for medical devices and IVDs as manufacturers adjust to the post-Brexit landscape. Manufacturers also had to find a new approach to the Switzerland market as that country has yet to finalize key agreements governing the medical device and IVD markets. 

This webinar discusses key changes anticipated across European markets, including: 

  • Anticipated updates to the EU IVDR 2017/746 and EU MDR 2017/745
  • What to look out for from the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Next steps for Switzerland and its mutual recognition agreement with the EU

ABOUT THE PRESENTER:

Ronald Boumans, a senior consultant for Regulatory Affairs with specific Brexit expertise will present the webinar. Ronald acts for Emergo in the European Association of Authorized Representatives (EAAR) and represents EAAR at the European Commission in Brussels. He has also helped the foundation of the U.K. Responsible Person Association (UKRPA), an organization that represents Responsible Persons for the U.K. and has frequent meetings with the MHRA.

This webinar was recorded on February 17, 2022.