Harmonised standards (HS) play a pivotal role in the European Union’s regulatory framework for medical devices, particularly under Regulation (EU) 2017/745 (MDR). These standards are instrumental in ensuring that medical devices meet stringent safety and performance criteria, thereby safeguarding public health across member states.
Definition of Harmonised Standards
According to Article 2 of the MDR, a ‘harmonised standard’ is defined as:
“a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012.”
Regulation (EU) No 1025/2012 further clarifies this definition:
“‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation.”
In essence, harmonised standards are European standards developed by recognised European Standardisation Organisations (ESOs), such as CEN and CENELEC, upon request from the European Commission. Once these standards are cited in the Official Journal of the European Union (OJEU), they provide a presumption of conformity with the legal requirements they aim to cover.
Use of Harmonised Standards
Article 8 of the MDR outlines the utilisation of harmonised standards:
“Devices that are in conformity with the relevant harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.”
This presumption of conformity simplifies the compliance process for manufacturers, as adherence to these standards demonstrates that their devices meet the essential requirements of the MDR. For instance, manufacturers can use harmonised standards to show compliance with the General Safety and Performance Requirements (GSPR) detailed in Annex I of the MDR.
Harmonised Standards and Common Specifications
While harmonised standards are the primary means for demonstrating compliance, there are instances where they may not exist or may be insufficient. In such cases, the European Commission, after consulting the Medical Device Coordination Group (MDCG), can adopt Common Specifications (CS). Article 9 of the MDR states:
“Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission… may adopt common specifications in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV.”
Common Specifications serve as a fallback mechanism, ensuring that all necessary aspects of device safety and performance are adequately covered, even in the absence of harmonised standards. Manufacturers are required to comply with these specifications unless they can duly justify that they have adopted solutions ensuring a level of safety and performance at least equivalent to the CS.Â
List of Harmonised Standards
The full list of HS to the EU MDR 2017/745 has not been fully published and currently only an initial number of standards have been published in the Official Journal of the European Union.
Among the current harmonised standards to EU MDR, we have:
- EN ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021): this is a standard related to biocompatibility evaluation of medical devices, for which we have already been discussing within QualityMedDev website.
- EN ISO 11135:2014 Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11135:2014/A1:2019; this topic has already been covered by our website by a specific article related to EtO sterilization and the approach it is possible to use for validation activities.
- EN ISO 11137-1:2015 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) EN ISO 11137-1:2015/A2:2019.
- 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 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 (ISO 25424:2018).
There are still a lot of missing standards if we consider that under the previous MDD (Medical device directive) and related directives (IVDD and AIMDD), the harmonised standards were:
- 47 for the AIMDD
- 268 for the MDD
- 43 for the IVDD
Regulatory Compliance in the Transition Period
Given that the harmonisation of standards is an ongoing process, there may be periods where certain standards are not yet harmonised under the MDR. During such transition phases, manufacturers are advised to adopt a hierarchical approach to demonstrate compliance:
- State-of-the-art versions of standards harmonised under the previous Directives: Utilising standards that were harmonised under the Medical Device Directive (MDD) and remain relevant.
- Other published standards identified as candidates for harmonisation under the MDR: Employing standards that are in the process of being harmonised and are recognised by the industry.
- International and European consensus standards (ISO/IEC or EN): Applying globally accepted standards that represent the current state of the art.
This approach ensures that manufacturers maintain compliance with the MDR’s requirements, even in the absence of a fully harmonised standard.
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