SME Success: How Eyenuk Traversed ’Stringent’ EU MDR For AI Eye Screening System
The new EU Medical Device Regulation sets a high bar for medtech companies. Kaushal Solanki, founder of US-based Eyenuk, tells Medtech Insight how the firm navigated the new regulation and gained two extra indication approvals for its class IIb eye screening device.
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The UK regulator is likely to establish mid-2024 as the new deadline for the standstill period during which CE-marked devices may access the UK market. Compulsory UKCA marking would accordingly also be delayed by a year.
Alignment with other relevant regulations, including medtech, should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence, according to MedTech Europe’s director for international affairs.
A work-sharing group made up of regulators in Australia, Canada, Singapore, Switzerland and the UK has been expanded to include advanced therapy medicinal products, which could lead to greater harmonization in the regulatory approaches taken by different agencies.