It is vital to involve patients in medical device development, regulatory assessments, and post-marketing activities. The European Patients’ Academy on Therapeutic Innovation (EUPATI) has explained why and what it is doing to drive progress.
Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.
Determining how to provide adequate clinical evidence for CE marking under the EU’s Medical Device Regulation can be a tricky business. But legacy device manufacturers will take comfort knowing they are familiar with some elements of the latest guidance.
The new EU Medical Device and IVD Regulations are reaching a critical tipping point. The 19-point plan just released is not going to cut it, medtech players fear. Is this really the lifeline needed for the medtech industry?
The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may be challenging the operability of some aspects of the new medtech regulations, especially for less mature businesses and SMEs. Legal medtech expert, Shuna Mason, of CMS explains why.
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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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