New MDR and IVDR harmonised standards published

May 11th, 2022, “Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices” and “Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices” were published in the Official Journal of the European Union (OJEU).

The Amending Regulation 2022/757 replaces reference 10:

  • It was originally referenced as: EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016). EN ISO 13485:2016/A11:2021
  • This has been replaced by: EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016). EN ISO 13485:2016/AC:2018 – EN ISO 13485:2016/A11:2021

Furthermore, the Amending Regulation 2022/757 adds 2 harmonized standards for medical devices to the Annex of Implementing Decision (EU) 2021/1182. Medical device manufacturers can reference these harmonized standards in order to satisfy conformity requirements under the MDR:

  • EN 285:2015+A1:2021 – Sterilization – Steam sterilizers – Large sterilizers 
  • EN ISO 14971:2019 – Medical devices – Application of risk management to medical devices (ISO 14971:2019). EN ISO 14971:2019/A11:2021

In turn, Amending Regulation 2022/729 replaces reference 7:

  • It was originally referenced as: EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016). EN ISO 13485:2016/A11:2021
  • This has been replaced by: EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016). EN ISO 13485:2016/AC:2018 – EN ISO 13485:2016/A11:2021

 

Amending Regulation 2022/729 adds 1 new harmonized standard for IVDs to the Annex of Implementing Decision (EU) 2021/1195. IVD manufacturers can reference these harmonized standards in order to satisfy conformity requirements under the IVDR:

  • EN ISO 14971:2019 – Medical devices – Application of risk management to medical devices (ISO 14971:2019). EN ISO 14971:2019/A11:2021

 

This list of harmonised standards will be regularly enlarged and updated, according to the development of the standardisation work at international and European levels, and the next proposals by CEN and Cenelec, usually each three months.

What does this mean to you?

As explained in MDCG 2021-5, the role of harmonised standards is key in implementing legislation because for product characteristics, the content of legislation is limited to establishing essential requirements that products intended to be placed on the EU market must meet. The technical details and solutions supporting those essential requirements are laid down in harmonised European standards. Products designed and manufactured according to applicable harmonised European standards the references to which are published in the OJEU benefit from a presumption of conformity with the relevant legal requirements. In other words, the use of harmonised standards cited in the OJEU confers presumption of conformity of the product with the legal requirements the standard aims to cover. Nevertheless, the use of harmonised standards is voluntary.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.

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