Press Release updated: Aug 24, 2018 08:00 EDT

TORONTO, August 24, 2018 – The new European Medical Device Regulations (MDR) and the In Vitro Diagnostic Medical Device Regulations (IVDR) represent some of the most wide-ranging and disruptive changes to recently affect the world’s second-largest medical technology market.

Now, with just a two- to four-year transition period before full compliance is required in 2020 for MDR and 2022 for IVDR, device developers will need to implement changes to help new and existing products succeed. The scope and complexity of this legislation will require significant changes in areas such as product development, data reporting, quality assurance and manufacturing processes. While these dates may seem a long way off, manufacturers need to start planning immediately, as adjusting will take time and effort.

Join Karen Hill, BSc (Hons), Senior Manager of Regulatory Affairs at ICON plc, on Monday, Sept. 17, 2018, at 1 p.m. EDT to learn:

  • The key changes that are occurring under the new regulations
  • How to prioritize product portfolios
  • The importance of early planning in preparing clinical studies to certify new devices and to recertify existing ones
  • How early transition can give products an advantage in the market

To learn more about this complimentary event, visit: How to Ensure Compliance with the New EU Medical Device Regulations: MDR & IVDR.

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Contact:

Nima Rajan
Tel: +1 (416) 977-6555 ext 352
Email: [email protected]

Source: Xtalks

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