BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an Notified Body (NB) under the Europe Union’s (EU) medical device regulation (MDR).
The scope of BSI UK’s new Medical Device Regulation (MDR) designation ranges from medical devices incorporating medicinal substances or nanomaterial to class III custom-made implantable devices, according to NANDO. BSI’s designation under the European Unions (EU’s) in vitro diagnostic regulations (IVDR) is reportedly set for upcoming months.
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.
Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen became the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR).
TÜV SÜD’s designation under the European Unions (EU’s) in vitro diagnostic regulation (IVDR), which goes into effect in May 2022, is still ongoing, with a notification expected by the end of this summer.
TÜV Süd’s designation covers all Notified Body Operations Group (NBOG) scope codes, but with some limitations like:
Apart from these two, many more Notified Bodies (NBs) are in line / under auditing process to be designated under Medical Device Regulation (MDR).