BSI started a NB in The Netherlands conducting Conformity Assessment and Certification Activities under the Medical Device Directives (Nov 2018: MDD, AIMD, IVDD) and the new Medical Devices Regulations¬† [Nov 2019: MDR and xx Dec 2019: (….)].

Furthermore, BSI in The Netherlands has been accredited (April 2018) by the Dutch Accreditation Council (RVA) to conduct conformity assessment and Certification activities for ISO 13485 “Medical Devices - Quality Management System”.

During the session, the process of accreditation and the process of designation as a Medical Devices Notified Body will be discussed. Furthermore, the impact of a (potential) Brexit on Certification will be discussed.

The British Standards Institution (BSI) is a large Notified Body (NB) for Medical Devices. BSI NB (NB 0086) is located in Milton Keynes in the UK. Bert Roossien (Regulatory Lead) will discuss how BSI has recently set up a second NB (NB 2797) for Medical Devices in The Netherlands.