With the deadline for class D high-risk IVDs less than 18 months away and the underpinning regulatory structure still embryonic, MedTech Europe calls for clearer policies to give manufacturers a good chance of overcoming the regulatory challenges in time.
It is important that all manufacturers who still need to apply for conformity assessment of their high-risk class D devices in the context of the IVD Regulation encounter improvements in the efficiency and predictability path to certification.
But, at present, manufacturers wishing to transition their class D IVDs to the IVDR “face numerous challenges.”
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TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.
Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
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