Harmonised European Standards

The General Framework for harmonised European Standards (hES)

Under the MDR 2017/745 and IVDR 2017/746 regulations, harmonized European standards (hES) play an important role. The legislation only sets out the basic requirements that products must meet to be sold in the European Union (EU). The technical details and specific product features needed to meet these requirements are provided in hES, which are created by European standardization organizations based on specific requests from the European Commission (EC).

In healthcare engineering, including medical devices, hES are developed by two main organizations: the European Committee for Standardization (CEN), which covers most medical devices, and the European Committee for Electrotechnical Standardization (CENELEC), which focuses on electrical medical equipment. Products that follow the relevant hES, published in the Official Journal of the European Union (OJEU), are assumed to meet the necessary legal requirements. In simpler terms, using hES listed in the OJEU gives a product a presumption of compliance with the law.

This special legal status of hES cited in the OJEU helps manufacturers and others, like notified bodies and national authorities, to streamline processes for assessing compliance, CE marking, bringing products to market, and overseeing product safety.

Voluntary use of standards

The voluntary character of the use of standards means in practice that the manufacturer may always choose to apply the technical solutions provided by hES whether the reference to it is cited or not cited in the OJEU, or by non-harmonised European standards, or by any other international or national standards, or even to develop its own technical solutions, provided that it is able to demonstrate that these different or alternative non-harmonised means are adequate to comply with the legal requirements applicable to the product. Such a demonstration can be given by the manufacturer through a more in-depth risk assessment, gap analysis, etc., to be reflected in the related technical documents and reports within the prescribed conformity assessment procedures on the product. 

Therefore, also in the medical devices field in the EU, choosing to use a standard or notbelongs to the manufacturer, within its overall and ultimate responsibility on compliance.With some exceptions, it is not possible to impose the use of any specific standard, on the basis for instance of its status of hES whether referenced in the OJEU or not, or of “state-of-the-art” standard, neither by national authorities in their market surveillance or vigilance activities, nor by notified bodies in the conformity assessment procedures they participate in. However, notified bodies performing conformity assessment activities must check whether the concerned device complies with the requirements of the Regulations on medical devices, and in this sense they must “where relevant, take into consideration available common specifications, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance”.

Exceptions that prove the rule: mandatory hES

At the same time, it is worth noting that for medical devices there are “exceptions that provethe rule” when standards can be regarded as mandatory: it is the case for symbols and identification colours that “shall conform to the harmonised standards” when harmonised standards the reference of which is published in the OJEU containing indications on symbols or colour coding are available. Also, Article 5(5)(c) IVDR contains a reference to standard EN ISO 1518922 which has a different role – it pertains to the scope and applicability of IVDR requirements under specified conditions but not to any presumption of conformity.Regarding the ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects mentioned in Recital 64 MDR, and to ISO 20916 on clinical performance studies using specimens from human subjects cited in Recital 66 IVDR, these should be viewed as non-binding examples only.

Conclusion

In the end, to be lawfully placed on the EU market, medical devices must comply with the general safety and performance requirements (GSPRs), and not necessarily with theclauses of a standard. On the other hand, compliance of a device must be assessed against the legal requirements that apply to it, and this may be made through compliance with the clauses of a standard (regardless of whether the standard is a harmonised standard cited in the OJEU or not).

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