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BSI-UK is designated as first Notified Body for the MDR

The British Notified Body BSI-UK is the first NB designated for the MDR, as can be seen in the European Database for Notified Bodies, NANDO. According to NANDO no NB has yet been designated for IVDs, but this may follow shortly.

The designation covers all NBOG codes, and for all these codes BSI is designated for Annex IX (I) (Quality Management System), Annex IX (II) (Assessment of Technical Documentation) and Annex XI (A) (Production Quality Assurance).

BSI is only designated for Annex X (Type Examination) and Annex XI (B) (Product Verification) for codes MDA 0305 (Active non-implantable devices for stimulation or inhibition), MDN 1210 (Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases), MDN 1214 (General non-active non-implantable devices used in health care and other non-active non-implantable devices – limited to gloves). In more general terms, BSI can audit quality system, review technical documentation but their testing capacities are limited.

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