The IMDRF has issued new guidance on the regulation of custom devices, which incorporates recommendations reflecting new advances in 3D printing and other personalized manufacture.
New final guidance on the regulation of personalized devices from the International Medical Device Regulators Forum (IMDRF) reflects recent technological advances that allow custom devices to be produced at a mass scale.
The 22-page document, which is dated 28 March but posted online last week, recommends a harmonized approach to ensure custom devices are regulated consistently across IMDRF member nations
While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.
One year after the UK mooted the Rules-Based Pathway to give medtechs clarity on what can be expected from an evaluation, the devices industry says UK healthtech assessment and adoption processes are still failing to meet the needs of innovators and patients.
“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”
