Tips and Tricks to EU MDR Technical Documentation Preparation
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 new standards.
Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and postmarket surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your medical device company navigate the higher level of scrutiny, including helpful advice on EU MDR technical documentation preparation:
- How to prepare MDR documentation in accordance with Annex II of the EU MDR 2017/745
- What information is required to be included
- What additional information is being requested in comparison to MDD
- Provide suggestions/tips on format and ways to address specific requirements
- Indicate what is no longer acceptable to notified bodies
This event, hosted by Medtronic, is coordinated by the RAPS Colorado chapter to encourage knowledge sharing and community development. Dinner will be provided and RAC holders may claim two RAC recertification credits.
Ratinder Dhami, director of regulatory affairs, Network Partners
RAPS Colorado Chapter Members: $30