EU MDR Compliance for Surgical Instruments: 2026 Guide
26 May 2021 changed what a plain steel forceps is, legally speaking. Under the old Medical Device Directive, a reusable Kelly clamp was Class I self-certified — the manufacturer wrote a Declaration of Conformity, kept a technical file, and shipped. Under Regulation (EU) 2017/745, that same clamp is Class Ir, and a notified body has […]
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