The New EU Medical Device Regulation

[Joseph Wilcox]

Traininng.com, a well-known provider of professional training for all the areas of regulatory compliance, will organize a 60-minute webinar on the topic, “The New EU Medical Device Regulation”, on February 21. Dr. Salma Michor, who is the founder and CEO of Michor Consulting Schweiz GmbH, who teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission, will be the speaker at this valuable webinar.

Please visit http://bit.ly/2XnIM2o to enroll for this webinar and gain incisive insights into the way in which the upcoming medical device regulations from the EU is going to impact medical device companies.

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In 2012, the European Commission (EC) adopted a package of measures aimed at ushering in changes of a far-reaching nature for the European Union (EU) in the field of medical devices. At the heart of this new set of changes is a Communication and two regulation proposals, all three of which seek to revise existing legislation on general medical devices and in vitro diagnostic medical devices.

As part of this package, there is a now stronger focus in the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) than before. Both of these instruments will be replaced by a Regulation on medical devices. Simultaneously, a Regulation on the same subject that will replace the Directive on in-vitro diagnostic medical devices (98/79/EC) will also come into effect. These are the products that come under these revisions include all kinds of medical devices:

• In-vitro diagnostic medical devices, including home-use items like sticking plasters, pregnancy tests and contact lenses
• X-ray machines, pacemakers
• Breast implants
• Hip replacements
• HIV blood tests.

Since this Regulation, which will replace the current Directive will be altered in a significant way and is legally binding on all Member States, knowledge of the ways of implementing this Regulation is imperative for medical device companies.

Proper understanding of this new Regulation is a must

It is this crucial knowledge that this webinar will offer. Salma will participants an understanding of what to expect when the new regulations get implemented. These are the areas she will cover when explaining these regulations:

• The updated Regulation
• Implementation dates and transition
• Main changes and products affected
• Effect on medical device manufacturers.

Clinical Trial Managers, Regulatory Affairs professionals, and Medical Officers, whose work this upcoming package will greatly impact, will benefit immensely from this webinar.

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About the speaker:

Dr. Salma Michor holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University. She has also earned the RAC (EU), CQA and is a Chartered manager. At Michor Consulting Schweiz GmbH, she has served a number of high-profile clients that have included illustrious names such as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive.