European market access

Given the stringent requirements on patient safety and device performance, accessing the European market brings challenges that can delay your product launch.  It is critical to work with a Notified Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

BSI The Netherlands (2797) is a leading Notified Body achieving full-scope designation under MDR and IVDR. We review your medical devices and IVDs to assess conformity against European Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to market.

Stay up to date with the latest updates from BSI