Clever Compliance - SWEDEN
Experienced leader, Board Member and expert with a demonstrated history of working in the medical device and lifescience industry. Skilled in All aspects of quality and regulatory affairs with long experience in most markets and handling of most authorities in the world. Working from strategy to whole way to the submissions, interim management, reorganization support quality systems, insourcing and outsourcing
All Sessions by Peter Löwendahl
LEGAL ISSUES: New CE requirements for medtech products/medical SWOnline
The rules for putting medical devices and IVD products on the market in EU are drastically changing very soon. The new regulations are adding many new requirements for all manufacturers but specific for the ones in the lowest risk class. This presentation discuss the overall changes vs today and a few critical considerations companies needs to do going forward. Unlike many other countries many software apps are getting regulated in the same way as traditional medical devices. For these devices there are still a few months to be registered according to the old regulation (25 May 2021) and hence be able to sell the product to 25 May 2024.