BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device regulation (MDR)
The scope of BSI UK’s new 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 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 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:
- Scope code MDN 1104 Non-active soft tissue and other implants: Annexes X and XI without breast implants
- Scope code MDT 2013 Devices which have undergone reprocessing: Only for medical devices that are foreseen by the manufacturer to undergo reprocessing
Astonishingly, the designation’s horizontal scope includes MDS 1012 Products without an intended purpose listed in Annex XVI to Regulation (EU) 2017/745, considering that the Common Specifications for Annex XVI of the MDR have not officially been published yet.
Apart from these two, many more NBs are in line / under auditing process to be designated under MDR.