EU medical devices regulation is very much in flux: the European Commission is working on the text of the recast of the medical devices directive (MDD), and work is underway on a new guidance on stand-alone software under the MDD. In the meantime, medical device companies are producing more software-enabled devices and software that might qualify as medical devices. Clinical institutions and others are developing an increasing number of medical apps and websites with diagnostic and therapeutic functionality. Given these developments, it is vital for companies and institutions to be aware of how these products are regulated, and to determine if and how their software products are regulated.

This audio conference presentation reviews the current EU rules for software related to or incorporated within medical devices, and also sheds light on where these regulations are likely headed in the future. Our speaker also discusses FDA guidance on mobile medical apps, and how it can help guide companies in their efforts in Europe.

This audio conference covers:

• EU requirements for software running on medical devices and as a stand-alone medical device
• Expected developments in the recast of the MDD
• How the recent FDA draft guidelines on mobile medical apps can apply in the EU, giving companies a transatlantic frame of reference for product development
• The progress on the EU MEDDEV guidelines for stand-alone software

About the speaker:

Erik Vollebregt has 13 years experience as an IP and regulatory lawyer, and is one of the founding partners of EU life sciences niche firm Axon. His practice comprises advice to and litigation for clients from the pharmaceutical, medical device and biotechnology industry in legal, regulatory, intellectual property and anti-trust matters. Erik is author of a number of publications on legal and regulatory subjects relating to pharmaceuticals and medical devices as well as editor of two legal journals in the field of pharmaceutical law and medical technology law, and author of the medical device law part of the Dutch language loose leaf commentary on pharmaceutical and medical technology law. He is a frequent speaker at national and international conferences of, among others, DIA and RAPS.

Who should attend?

• Regulatory Affairs
• In-house Legal Counsel
• External Counsel
• Marketing
• Business Development