Anticipated Upcoming Changes in European MedTech Regulation: Business impact and practical considerations

Monday, March 24 2014
11:30 am – 1:30 pm

This event was posted by Voisin Consulting, Inc.

Location: MassBio's Collaboration Room, 8th Floor

Anticipated Upcoming Changes in European MedTech Regulation: Business impact and practical considerations

Voisin Consulting Life Sciences invites you to participate in a discussion on how the European regulatory scene will evolve in 2014, and what impact it will have for manufacturers.

March 24th, 2014 – 11:30am-1:30pm –

Massachusetts Biotechnology Council – Contact Melanie Rausch

 Devices are under high scrutiny in Europe. Medical devices, In-Vitro diagnostics tests and drug/device combination products have been the subject of a 3-year debate, and with so many articles and opinions flying around about proposed changes, it can be hard to anticipate the impact on products under development, or placed on the market.

 The discussion will explore the expected benefits of the significant changes that the MedTech regulatory environment is about to experience and the foreseeable impact on time to market and companies' ability to operate efficiently (i.e. prevention of delays, market denials, etc.). Insights will be shared regarding new stakeholders for CE marking - Special Notified Bodies (SNB) and Medical Devices Coordination Group (MDCG). In addition, the revised procedures, regulators expectations in terms of vigilance, market surveillance and clinical evidence to gain market approval will be discussed. Christophe Amiel will also speak on the supervision process for high-risk devices - which remains a controversial issue - and timelines for adoption of the new regulations.

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