E-ssentials MedDev Blog

Regulatory updates for the medical device industry

“Animal Origin”: International conference with first-hand information

In only two years’ time, application of the new MDR will become binding. These new regulations also apply to medical devices incorporating materials of animal origin. Learn more about the regulations and risks related to animal origin at our international conference in Munich on May 14, 2018.

New scientific findings on TSE risk

There is no doubt of the effectiveness and biocompatibility of medical devices incorporating materials of animal origin. However, these devices nevertheless hold certain residual risks, such as diseases being transmitted by viruses or other pathogens. At our “Animal Origin” international conference, TÜV SÜD expert Dr. Ursula Lauer provides insights into the current research on risk minimization, focusing in particular on Transmissible Spongiform Encephalopathy (TSE). A further talk on the topic of TSE risk will be presented by Dr. Immo Rettmer from Miltenyi Biotec GmbH. In his talk “The numbers of the beasts,” he will explain the significance of regulations 745/2017, 722/2012, and the EN ISO 22442 standard.

Best cases from the perspective of a notified body

What will the future bring, and how to ensure compliance as a manufacturer? TÜV SÜD expert Dr. Susanne Rubenwolf approaches the topic from another perspective: At the conference in Munich she will present the current legislative framework in relation to TSE-relevant and non-TSE-relevant animal species. In addition to this, she will address the future developments that await TÜV SÜD as a notified body and present reference examples. Especially interesting for manufacturers of medical devices incorporating materials of animal origin will be Dr. Lauer’s talk in the afternoon, which will highlight special aspects in the production process, such as the traceability of materials and the requirements of supplier audits.

Registration for the “Animal Origin” conference

Our international conference will take place at Holiday Inn Munich Westpark on May 14, 2018, from 8.30 a.m. to 6 p.m. Places are limited! Given this, why not register now: Go to registration

Further information

More information about the topic of medical devices incorporating materials of animal origin is available on our website.

E-ssentials MedDev Team

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