In the first week of January 2022, Commission Implementing Decision (EU) 2022/6 concerning new harmonised standards MDR (EU) 2017/745, and Commission Implementing Decision (EU) 2022/15 on new harmonised standards IVDR (EU) 2017/746 have been published on the Official Journal of the European Union.
These standards are in addition to the first standards harmonised MDR and IVDR published in July 2021.
Please remember that harmonised standards are European standards drawn up by a European Standardisation Organisations (ESO), such as CEN, CENELEC, ETSI, and they are valid for all EU countries.
The goal of harmonised standards is to help Third parties in interpreting security requirements to obtain the conformity of the product.
9 new standards MDR harmonised
The EU Commission Implementing Decision (EU) 2022/6 of 4th January 2022 has modified the Implementing Decision (EU) 2021/1182 regarding 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.
The paper provides 9 new standards harmonised MDR in addition to the five already published in the previous Implementing Decision (EU) 2021/1182, for a total amount of 14 standards harmonised MDR issued:
1.EN ISO 10993-9:2021
Biological evaluation of Medical Devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019).
2.EN ISO 10993-12:2021
Biological evaluation of Medical Devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021).
3.EN ISO 11737-1:2018
Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018).
EN ISO 11737-1:2018/A1:2021
4.EN ISO 13408-6:2021
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021).
5.EN ISO 13485:2016
Medical Devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016).
EN ISO 13485:2016/A11:2021
6.EN ISO 14160:2021
Sterilization of health care products – Liquid chemical sterilizing agents for single-use Medical Devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for Medical Devices (ISO 14160:2020).
7.EN ISO 15223-1:2021
Medical Devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021).
8.EN ISO 17664-1:2021
Processing of health care products – Information to be provided by the medical device manufacturer for the processing of Medical Devices – Part 1: Critical and semi-critical Medical Devices (ISO 17664-1:2021).
9.EN IEC 60601-2-83:2020
Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment.
EN IEC 60601-2-83:2020/A11:2021».
5 new standards harmonised IVDR
On 6th January 2022, it was published the Commission Implementing Decision (EU) 2022/15 that edits the Implementing Decision (EU) 2021/1195 regarding 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.
The paper presents the following five new standards harmonised IVDR in addition to the other four harmonised standards published in July 2021:
1.EN ISO 11737-1:2018
Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018).
EN ISO 11737-1:2018/A1:2021
2.EN ISO 13408-6:2021
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021).
3.EN ISO 13485:2016
Medical Devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016).
EN ISO 13485:2016/A11:2021
4.EN ISO 15223-1:2021
Medical Devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021).
5.EN ISO 17511:2021
In vitro diagnostic Medical Devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)’.
As of today, a total of 9 standards harmonised IVDR were therefore issued.
Do you need any help adjusting to MDR and IVDR Regulations?
Through our strategic-regulatory consultancy services we can fully support you in the adjustment process to MDR (UE) 2017/745 and to IVDR (UE) 2017/746.
Contact us for information!
Source:
COMMISSION IMPLEMENTING DECISION (EU) 2022/6, Official Journal of the European Union, 4 January 2022
