BREXIT’s Impact on Medical Devices – Webinar Recording/Transcript
BREXIT’s rapidly approaching deadline — Jan. 1, 2021 — means changes are coming to getting your devices certified, obtaining a UK Conformity Assessed (UKCA) mark and registering your device with the Medicines and Healthcare products Regulatory Agency (MHRA).
Make no mistake: this will require additional effort over and above what you’re planning and implementing for the EU Medical Device Regulation (EU-MDR) and In Vitro Diagnostic Regulation (EU-IVDR).
You need to put a plan in place now to ensure your devices can be sold in the UK going forward, after the clock strikes Jan. 1, 2021 and the BREXIT-related changes begin.
Dan O’Leary, President of Ombu Enterprises, will not only explain the guidance documents, he’ll use change documents to a prior version of the UK regulations to highlight the inevitable issues you must address to sell devices there after Brexit.
- How the BREXIT transition will impact medical devices
- The timeline for action
- The role of the UK Conformity Assessed (UKCA) mark
- Making sense of the UK conformity assessment bodies
- The separate rules for Northern Ireland
- Some of the planned changes in the UK regulations
By understanding the clues to be uncovered in these change documents and what BREXIT means for your devices, you can plan for the modifications to come and ensure your products will be accepted into the UK market after Jan. 1, 2021.
Meet Your Presenter
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. He has a Master’s Degree in Mathematics; is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit
Manufacturers who plan to market medical devices in the UK after Jan. 1, 2021, particularly:
- Quality Managers
- Regulatory Managers
- Marketing Managers
- Compliance Specialists
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Nov. 19, 2020