New scope designation to include non-standard sterilization modalities for sterile medical devices

Date: 25 May 2023

BSI The Netherlands Notified Body (2797) is now ready to support the strategic goals of the medical device industry as it seeks to introduce new technologies and drive sustainability. Concerns over sterilization capacity, availability of natural resources and environmental exposure have grown over the past decade leading to exploring alternative sterilization modalities.

On 8 March 2023, BSI’s scopes of designation under MDR and IVDR were expanded to include six new sterilization modalities.

We are the first Notified Body to achieve this designation to allow CE marked devices using such technologies onto the EU market. In absence of dedicated ISO standards, these sterilization modalities will be assessed under ISO 14937 by our global team of 40 Microbiology Technical Specialists.