In May 2022, Commission Implementing Decisions (EU) 2022/757 on new harmonized standards for MDR and 2022/729 on new harmonized standards for IVDR were published in the Official Journal of the European Union. New standards are the second 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.
Two new MDR standards have been harmonized and entry of one harmonized standard updated
Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amended Implementing Decision (EU) 2021/1182 concerning harmonized standards for quality management systems, sterilisation and application of risk management to medical devices.
The document adds two new harmonized standards for MDR in addition to the fourteen already published in the previous Implementing Decisions (EU) 2021/1182 and 2022/6. Entry for harmonized standard for quality management systems is updated.
One new IVDR standard has been harmonized and entry of one harmonized standard updated
Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amended Implementing Decision (EU) 2021/1195 as regards harmonized standards for quality management systems and for application of risk management to medical devices.
The document adds one new harmonized standard for IVDR in addition to the nine already published in the previous Implementing Decisions (EU) 2021/1195 and 2022/15. Entry for harmonized standard for quality management systems is updated.
Harmonized standard for quality management systems EN ISO 13485:2016 is updated with amendment A11:2021. It includes two new annexes ZA and ZB, which cover the relationship of this standard with:
- the general obligations of the manufacturer in Article 10 of MDR and IVDR and
- the quality management system requirements in the conformity assessment annexes (Annexes IX and XI of MDR and IVDR).
In addition, this Annexes include a description of the regulatory processes and activities undertaken by the notified body, competent authority and European Commission, which are outside of the scope of EN ISO 13485 and therefore not covered by the standard.
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