Policy & Regulation
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FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot
The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices.
FDA Offers Draft Guidance For Developers Of Drug Delivery Devices
The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.
EU Regulatory Roundup, May And June 2024: Sweeping New Proposals Take Medtech By Surprise
During this period of intense regulatory pressure for the medtech industry, work has been ongoing in the background to try and find a better way forward for the medtech industry, for innovation and for patients.
Amendments To Breakthrough Device Coverage Act Push Bill Out Of House Ways And Means Committee
The amendment introduced to the Ensuring Patient Access to Critical Breakthrough Products Act in the Ways and Means committee markup of helped usher the legislation to a passing vote.
EU Regulatory Roundup, May And June 2024: Sweeping New Proposals Take Medtech By Surprise
During this period of intense regulatory pressure for the medtech industry, work has been ongoing in the background to try and find a better way forward for the medtech industry, for innovation and for patients.
Does The AI Act Apply To My Medtech Product And What Do I Need To Know?
The AI Act is due for publication in July 2024. Marco Caproni of notified body, TÜV SÜD, explained how requirements over and above those in the MDR and IVDR impact medtech manufacturers.
MedTech Forum: Experts Suggest Short And Long-Term Solutions To EU’s Innovation Crisis
After focusing on the severity of the EU’s regulatory innovation crisis, Medtech Insight now reports on discussions in Austria last month on a range of changes that could improve the outlook for cutting-edge products.
MedTech Forum: Is Global Regulatory Convergence Needed To Address EU’s Slow Innovation Exodus?
Does the difference in the height of the respective regulatory bars for innovation in the EU and US matter? And how severe are the problems being created by companies choosing to launch new products outside the EU? Hear the views of speakers at the Medtech Forum in Vienna in this first section of a two-part report from a session at the conference on innovation.
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