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And a follow up – A similar challenge I see in the sector is around distinguishing wellbeing products from regulated medical devices. Many companies aim to position themselves in the wellbeing space to avoid the regulatory burden, but their marketing or functional claims can easily push them into “medical” territory. From your experience, where does the real line lie between wellbeing and medical under the MDR, and what kinds of claims or design features most often cause companies to inadvertently cross that line?
In my experience working with early-stage medtech companies, I often see uncertainty around whether a device should be classified as Class I or Class IIa under the MDR. Many teams aim for a Class I designation to minimise cost and regulatory burden but ultimately find themselves slipping into Class IIa territory. From your perspective as a regulatory expert, what are the key indicators that clearly distinguish Class I from Class IIa classification, and what are the most common pitfalls companies make when trying to justify a lower classification?