Updates to the list of standards harmonized for the European medical devices Directives

Commission Decisions on harmonized standards published in the Official Journal

The medical devices Directives  (Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC) have specific roles for harmonized standards in demonstrating conformity. Harmonized standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonized standards are presumed to be in conformity with the requirements of the Directive covered by those standards.

On 25 March 2020, three Commission Implementing Decisions on harmonized standards were issued to support these three Directives. This is a new format for updating the list of harmonized standards. The new format reflects revised procedures to implement the Standardization Regulation and some recent rulings of the European Court of Justice. The decisions replace previous communications in November 2017. Each decision includes two annexes:

• Annex I has a consolidated list of references for harmonized standards, including those previously published and new additions
• Annex II has a list of standards withdrawn from the harmonized list

For the

• MDD there are 264 harmonized standards listed, including 17 new or revised standards. Twelve standards have been withdrawn.
• AIMDD there are 46 harmonized standards listed, including 5 new or revised standards. Four standards have been withdrawn.
• IVDD there are 41 harmonized standards listed, including four new or revised standards. Three standards have been withdrawn.

The new and revised standards included in the lists include several horizontal standards:

• EN ISO 13485:2016/AC:2018, the corrigendum to Medical devices — Quality management systems — Requirements for regulatory purposes
• EN ISO 17664:2017; Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
• EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
• EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration
• EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

These decisions are intended to be the last communications on harmonization for the Directives. They are applicable until 26 May 2024 under the transitional arrangement to the Medical Devices Regulations (MDR) and to the In Vitro Diagnostic Medical Devices Regulations (IVDR).  The presumption of conformity of the withdrawn standards ends on 30 September 2021. This gives the withdrawn standards an 18 month of transitional period. If you are using any of the withdrawn standards for a presumption of conformity, you should plan to transition to the updated version.

The harmonized standards listed under the Directives cannot be used to provide a presumption of conformity with the requirements of the MDR and the IVDR. The draft Standardization Request to support the MDR and the IVDR continues to progress. The Standardization Request provides the legal basis to start publishing references to harmonized standards that provide a presumption of conformity under the MDR and the IVDR.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development