Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.
Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.
Shortfalls in manufacturer technical documentation submitted to notified bodies cause delays for manufacturers and notified bodies alike. A new document from the notified body association, TEAM-NB, aims to streamline processes.
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.
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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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