MEDCERT’s Klaus-Dieter Ziel, TÜV SÜD Product Service’s Bassil Akra and Qserve Group’s Gert Bos answered questions about the EU’s new Medical Device and In Vitro Diagnostic Regulations at MedCon 2019.
Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.
2018 needed to be medtech’s year to focus on the ongoing implementation of the EU MDR and the IVDR and the structures and documents to support them. But lack of progress means a 2019 work bulge amid Brexit issues and recent journalistic investigations. Here’s a look at the top EU regulation issues and articles of the past year.
Manufacturers who have not managed to transfer their certificates from a UK notified body prior to Brexit, or who have not obtained certificates under the EU Medical Device or IVD Regulations in time, can not expect to receive a sympathetic hearing from the EU Commission. In an interview with Medtech Insight, Lawyer Alison Dennis examines options for medtech firms.
The latest revelations in London and Brussels over the last week show concrete progress is being made toward the designation of notified bodies. But which organizations will be named first and when?
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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