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The new EU Medical Device & IVD Regulations: Implementation Insights Workshop
5th February 2019 @ 10:00 am - 4:30 pm£180
Medilink members fee – £180 + VAT per delegate*
Medilink non-members fee – £215 + VAT per delegate*
15% Christmas bonus discount will be applied to all bookings made before 5 January 2019!
The new EU Medical Device Regulation (MDR) is in its implementation phase and will be effective from May 2020. All medical devices will need to comply with this new legislation. Similarly, the IVD Regulation (IVDR) will be in force from May 2022. Many companies are not yet ready for the journey let alone have a roadmap of how to get to compliance. Join this interactive workshop to find out more about the key areas of change within the MDR and IVD regulations.
This one-day event will:
• Provide you with an overview of the key areas likely to need upgrading to comply with the MDR/IVDR
• Assist you in assessing your company’s current preparedness for the transition
• Give you a clear, practical guide to the next steps that you and your company need to take to gain CE Marking under the MDR/IVDR
• Gain an overview of the new EU Medical Device and IVD Regulations
• Understand the key areas of compliance required
• Understand the technical documentation that should be in place for each device
• Gain a plan of action for implementation and CE Marking under the new legislation
Medical Device & IVD companies as well as those Pharma companies with combination products
C-suite, executives, product owners, medical officers, regulatory and clinical specialists within a company that need to understand the overall requirements of the new Medical Device Regulation and IVD Regulation for their medical devices to enable them to place a device on the market and to maintain access after May 2020. All company sizes will find it useful, but particularly helpful for smaller, resource constrained organisations.
*Invoices to be forwarded after registration.