Harmonised standards updated for MDR IVDR
8/1/2022
On 4th Jan, COMMISSION IMPLEMENTING DECISION regarding Harmonised Standards (HS) was published.
This publication focuses on amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment.
11 Harmonised Standards were added to EU MDR:
EN ISO 10993-9:2021
EN ISO 10993-12:2021
EN ISO 11737-1:2018
EN ISO 11737-1:2018/A1:2021
EN ISO 13485:2016
EN ISO 13485:2016/A11:2021
EN ISO 14160:2021
EN ISO 15223-1:2021
EN ISO 17664-1:2021
EN IEC 60601-2-83:2020
EN IEC 60601-2-83:2020/A11:2021
Additionally,
7 HS entries were added to EU IVDR.
COMMISSION IMPLEMENTING DECISION (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.
7 HS entries EU IVDR:
EN ISO 11737-1:2018
EN ISO 11737-1:2018/A1:2021
EN ISO 13408-6:2021
EN ISO 13485:2016
EN ISO 13485:2016/A11:2021
EN ISO 15223-1:2021
EN ISO 17511:2021
What does this mean for your #MedicalInnovation?
Let our experts guide you!
Drop us an email at mdd@mddltd.com and we shall be there to be your regulatory risk partners.
