May 13, 2019 - May 14, 2019
Date: May 13 & 14, 2019
Location: Brussels, Belgium
RAPS Regulatory Conference – Europe 2019 is the inaugural conference designed by European regulatory affairs professionals for European regulatory professionals. It’s where the regulatory community will gather to discuss the most pressing regulatory topics, share experiences and network with other stakeholders.
A wide range of current issues facing medical device, IVD and medicines regulatory professionals will be covered, as well as general subjects that impact all professionals in the healthcare products space.
Substance-Based Medical Devices and the Regulatory Implications of the EU Medical Device Regulation (EU 2017/745)
Session Leaders and Speakers: Anja Wiersma, mi-CE consultant and Inette Nieveen, Qserve Group.
1. Describe what are the new requirements for the substance-based medical devices comparing the Medical Device Directive (MDD) with the Medical Device Regulation (MDR).
2. Prepare gap analysis of the current products placed on the market and to show compliance with the EU MDR, rule 21 requirements.
3. Make regulatory strategic plan on the rule 21 products including the impact of the potential notified bodies decisions not to prioritize these product groups.
With offices in the USA, Europe, and China we are an essential partner for medical device manufacturers. With our global team of multilingual consultants, Qserve's expertise and experience provide international support, on a local level.