Final updates to the list of standards harmonised for the European medical devices directives

Commission Implementing Decisions for harmonised standards update list of standards in Official Journal

The medical devices directives (Medical Devices Directives (MDD) 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC) have specific roles for harmonised standards in demonstrating conformity. Harmonised standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonised standards are presumed to be in conformity with the requirements of the Directive covered by those standards.

Three Commission Implementing Decisions for harmonised standards were adopted in April 2021 and published in the Official Journal. There is a separate decision for each of the three directives. These implementing decisions present the final updates to the list of harmonised standards that give a presumption of conformity for the directives for medical devices. These updates leave the final numbers of standards harmonised under the directives for medical devices as:

• 47 for the AIMDD, an increase of one from the previous list;
• 268 for the MDD an increase of four from the previous list; and,
• 43 for the IVDD, an increase of two from the previous list.

In addition to the inclusion of new harmonised standards, the decisions update the edition of some standards that are listed in the Official Journal to the more recent editions. For the standards supporting the MDD, the updates to the edition of the standard include several horizontal standards, namely:

• EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
• EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
• EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
• EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
• EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
• EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
• EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020).

These updates close some of the gaps between the harmonised standard listed in the Official Journal and the latest version of the standard, which can be considered to represent the state of the art.

Although Date Of Application of the Medical Devices Regulation (MDR) is 26 May 2021, manufacturers can still use harmonised standards to support certificates or declarations of conformity for the MDD to place devices onto the market until their certificates expire or until 26 May 2024, whichever is the sooner. Manufacturers using standards to support conformity with the directives should be aware of the changes in the lists of harmonised standards and assess how these affect their claims of conformity.

These lists of harmonised standards under the directives cannot be used to provide a presumption of conformity with the requirements of the medical devices regulations. Separate lists of harmonised standards need to be published in the Official Journal for the MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Approval of the Standardization Request to support these regulations provides the legal basis to start publishing references to harmonised standards that provide a presumption of conformity under the MDR and 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