How does this standard apply to you as a manufacturer? Do manufacturers with MDD compliance need to comply with ISO 13485:2016/A11:2021?Īlthough medical device companies who are already in compliance with the ISO 13485:2016 and have their Quality Management well established are considering the additional requirements stated in the MDR 2017/745 regulation or IVDR 2017/746 regulation pertaining to regulatory requirements, however, to be in compliance with the MDR or IVDR requirements (from a quality perspective), especially for the items that are not covered or are partially covered under ISO 13485: 2016, this standard can guide the manufactures to keep a track of the gaps and start updating their documents to allow for a smooth transition from MDD to MDR or IVDD to IVDR. Annex ZB: This annexure details the additional QMS requirements for in-vitro diagnostic devices as per IVDR 2017/746 when compared with ISO 13485:2016.Annex ZA: This Annexure lists down the additional QMS requirements for medical devices as per MDR 2017/745 when compared with ISO 13485:2016.The amendment introduces the following Annexures under the existing standard: As we know the EU MDR regulation has already been into effect from May 26, 2021, and the EU IVDR regulation shall be coming into effect from May 2022, hence this standard shall be beneficial for manufacturers in updating their documents and aligning with the additional QMS requirements as per MDR 2017/745 and IVDR 2017/746. In a nutshell, the amendment aims to align the ISO 13485 requirements for medical devices and in-vitro diagnostic devices with the EU MDR 2017/745 and EU IVDR 2017/746 Quality Management System criteria. This article focuses on the 2021 amendment of the ISO 13485 standard released by the British Standards Institute (BSI). The question which most of us have is: “What is new in the 2021 amendment of ISO 13485 standard?” Do not worry! We have the answers for that! The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst medical device organizations and quality professionals.

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