In June 2015, the EU Council published a set of revisions to the EU medical devices and IVD regulatory proposals, originally published in 2012 by the EU Commission. As the regulatory process moves forward, medical device manufacturers wait for the updated regulations to analyze on how to absorb important points like conformity assessments and reclassifications. The compromise documents that were published in June take medical device manufacturers another step forward in the process of understanding their evolving regulatory requirements.
The webinar will cover topics like:
- Reclassifications and regulatory scope expansions,
- Conformity assessment changes proposed in the documents, and
- What the next steps are in the process.