EU: New harmonized standards for MDR and IVDR regulation have been published

In the first week of January 2022, Commission Implementing Decisions (EU) 2022/6 on new harmonized standards for MDR and 2022/15 on new harmonized standards for IVDR were published in the Official Journal of the European Union. The standards are in addition to the first harmonized standards for MDR and IVDR published in July 2021.

The harmonized standard is a European standard developed by a recognized European standards organization: CEN, CENELEC or ETSI and published in the Official Journal of the European Union. Manufacturers, other economic operators or notified bodies may use harmonized standards to demonstrate that devices, services, or procedures comply with the requirements of MDR/IVDR.

Nine new MDR standards have been harmonized

Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amended Implementing Decision (EU) 2021/1182 concerning harmonized standards for the biological evaluation of medical devices, sterilization 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 document adds nine new harmonized standards for MDR in addition to the five already published in the previous Implementing Decision (EU) 2021/1182.

Five new IVDR standards have been harmonized

Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amended 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

The document adds five new harmonized standards for IVDR in addition to the four already published in the previous Implementing Decision (EU) 2021/1195.

Two new harmonized standards must be mentioned, EN ISO 13485: 2016 and EN ISO 15223-1: 2021, which can be used by all economic operators, including distributors and importers, to meet the requirements of MDR/IVDR.

EN ISO 13485:2016

Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/A11:2021

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)

We have already included individual contents of the mentioned standards in our trainings in the field of storage, distribution and import of devices and inspection of devices. We are also preparing a new training, which will present the standard EN ISO 15223-1:2021 and some new symbols and their use, as well as the new standard EN ISO 20417:2021, information provided by the manufacturer, which is not yet harmonized, but in combination with EN ISO 15223-1: 2021 is of great help in preparing the information provided by the manufacturer on the label, packaging, instructions for use as well as in the verification of this information by the distributor and importer.

Do you need additional knowledge or assistance in meeting the requirements of MDR/IVDR?

With the help of our educations and consulting services, we can help you meet the requirements of the MDR/IVDR.

Resource:

COMMISSION IMPLEMENTING DECISION (EU) 2022/6, Official Journal of the European Union, 4th January 2022

COMMISSION IMPLEMENTING DECISION (EU) 2022/15, Official Journal of the European Union, 6th January 2022