Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3 to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.”
The acquisition brings MAXIS’ expertise in pre-clinical engineering, design validation and verification, regulatory affairs, field clinical services, and trial management to Avania’s contract research and MedTech development capabilities.
The FDA is hosting a webinar on February 2 for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices.
The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device Regulation. The proposal will now be negotiated by the European Parliament and the Council.
One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.
The acquisition expands Veranex’s European footprint as well as the scale and scope of its clinical studies capabilities.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.
The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
