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EU MDR Annex II Technical Documentation Details: Too Much? Too Little? What is “Just Right”?

6.0
RAC Credits
Monday, 21 September 2020 (9:00 AM) - Tuesday, 22 September 2020 (2:00 PM) Eastern Time (US & Canada)
As the EU Medical Devices Regulation (MDR) is soon to be the governing regulation for medical devices in Europe, manufacturers are actively updating their existing device technical documentation. The summary documentation is expected to provide greater detail than had previously been required, but how much detail is enough?

Manufacturers find themselves in a conundrum when choosing between explicit detail in the summary technical documentation (potentially hastening review and approval by the notified body) vs. driving resource efficiencies in maintenance of the information and global submission strategies. ’How much detail is sufficient?’ is a common question to be addressed through speakers and attendees sharing their experiences.

Pricing Amounts & Deadlines 

6/23/2020 -8/14/2020:  Early Bird $400.00 Member | $500.00 Nonmember

8/15/2020 – 9/18/2020:    Regular $500.00 Member | $600.00 Nonmember


Objectives

  • Describe the appropriate level of detail to support the requirements of EU MDR Annex II.
  • Provide examples of continuity of device information throughout the summary Technical Documentation and why this is important.
  • Discuss practices to establish resources to maintain the documentation compliant to regulation.


Who Should Attend?
Regulatory professionals and managers with responsibility for preparing summary technical documentation for the EU MDR will find this topic beneficial.


Click here to download the agenda

Speakers

Julien Senac, Phd, Director, IVD Global Focus Team, TÜV SÜD


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Program Contact

Stephany Evans
Meeting and Events Specialist
Regulatory Affairs Professionals Society® 
Tel: 301 770 2920, ext. 229
5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA