21 January 2026

Since the EU Medical Device Regulation (EU-MDR) came into force, Swissmedic has aligned its authorisation requirements for medicinal products with integral medical device components with EU rules. Applications must include a Notified Body Opinion (NBOp) confirming that the device component meets the general safety and performance requirements. A review of ten NBOps revealed frequent deficiencies, including unclear scope and incorrect classifications. Based on this analysis, Swissmedic issued guidance on the key content and expected quality of NBOps, emphasising that applicants are responsible for ensuring their completeness and plausibility.

For more information, see here.