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Another Notified Body shuts up shop

  • Posted by: inetika
  • Category: GLOBAL NEWS

UL International, designated as a Notified Body (NB) by the UK Medicines and Healthcare products Agency (MHRA) is one more NB that has decided not to offer services under the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746), and has reached an agreement with the Polish NB Polskie Centrum Badan I Certyfikacji (PCBC), for existing MDD/IVDD UL clients to transfer their certificates to PCBC.

With regards to the MDR and IVDR, PCBC has applied for designation under both, with designation expected in time for the end of the MDR transition next May. Although UL will no longer be a NB, it will operate as a subcontractor to PCBC for audits and technical file assessments.

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