MDR’s hidden toll: why small medtechs are exiting the EU market

MDR was supposed to raise the floor on patient safety and create a harmonised single market. To be fair, the theory is sound. In practice this means a much higher bar of clinical evidence, heavier technical documentation (Annex II), and ongoing post-market obligations (Annex XIV) that scale poorly for small teams. I’ve watched otherwise-viable Class IIa and IIb manufacturers in Switzerland and the EU quietly stop selling into Europe because the compliance bill didn’t add up. Genau — it’s not gla