Chicago Chapter: EU MDR Updates – Annex II Technical File Documentation

When:  Nov 8, 2018 from 5:15 PM to 8:45 PM

Thursday, 8 November 2018
5:15–8:45 pm CDT
Hollister Inc.
2000 Hollister Drive
Libertyville, IL 60048
+1 800 323 4060

On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards.

The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come engage with professionals from your local regulatory community for an interactive session on how to prepare for the implementation and learn strategies to help your device company navigate the higher level of scrutiny, including:

  • Annex II Technical File Documentation. (EU MDR 2017/745 ANNEX II TECHNICAL DOCUMENTATION: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include the elements listed in this Annex.)
  • Classification rules of MDR
  • Technical documentation assessment process
  • How to ensure a smooth transition to MDR certification
  • Latest updates on EU MDR

This program, hosted by Hollister Inc., is brought to you by the RAPS Chicago chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim three RAC recertification credits.

Featured speaker:
Caroline Dore Geraghty, head of medical devices, NSAI (National Standard Authority in Ireland)

Registration Information:
RAPS Members:  $30
Nonmembers:  $45


2000 Hollister Dr
Libertyville, IL 60048-3746