As for the generality of the EU harmonisation legislation on products in the internal market based on the principles of the “New Approach” and the “New Legislative Framework” policies, the use of standards (either harmonised European standards the reference of which is published in the Official Journal of European Union or any other standard) in the medical devices sector is and remains voluntary. This is clearly stated in the Standardisation Regulation (EU) 1025/2012 ruling the whole system, starting with the Recitals which explain the background, and then in the enacting part (Articles) of the act:

• Recital (1): “The primary objective of standardisation is the definition of voluntary technical or quality specifications with which current or future products, production processes or services may comply.”
• Recital (2): “European standardisation is organised by and for the stakeholders concerned based on national representation (the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec)) and direct participation (the European Telecommunications Standards Institute (ETSI)), and is founded on the principles recognised by the World Trade Organisation (WTO) in the field of standardisation, namely coherence, transparency, openness, consensus, voluntary application, independence from special interests and efficiency (‘the founding principles’).”
• Article 2(1): “‘standard’ means a technical specification, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following: (a) ‘international standard’ means a standard adopted by an international standardisation body; (b) ‘European standard’ means a standard adopted by a European standardisation organisation; (c) ‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation; (d) ‘national standard’ means a standard adopted by a national standardisation body”.

These provisions are fully applicable also to the EU legislation on medical devices, which contains direct and indirect references to the voluntary use of standards, both in their recitals and enacting terms (19). At the same time, it is worth noting that for medical devices there are “exceptions that proves the rule” when standards can be regarded as mandatory: it is the case for symbols and identification colours that “shall conform to the harmonised standards” (20) when harmonised standards the reference of which is published in the OJEU containing indications on symbols or colour coding are available (21).

On the other hand, Article 5(5)(c) IVDR contains a reference to standard EN ISO 15189 (22) which has a different role. It defines a condition which needs to be met by health institutions when making use of exceptions, i.e. “the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation”. In the absence of national provisions, the health institution needs to be compliant with this standard to fall under the exception rule; here the standard is related to the scope and applicability of IVDR requirements under specified conditions, but not to any presumption of conformity.

In the case of the references to “the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects” included in Recital 64 MDR and to “the international standard ISO 20916 on clinical performance studies using specimens from human subjects” in Recital 66 IVDR, they must be considered as non-binding examples only.

The voluntary character of the use of standards means in practice that the manufacturer may always choose to apply the technical solutions provided by harmonised European standards whether the reference to 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. Only in case of harmonised standards the references of which have been published in the OJEU, presumption of conformity can be claimed for the requirements of the Regulations which are listed as “covered” in the respective informative Annexes Z of such standards (see point 2.3).

Therefore, also in the medical devices field in the EU, choosing to use a standard or not belongs to the manufacturer, within its overall and ultimate responsibility on compliance. With the possible exceptions referred to above, it is not possible to impose the use of any specific standard, on the basis for instance of its status of harmonised European standard 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 CS, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance” (Sections 4.5.1 of Annexes VII to the MDR and the IVDR) (see also point 3.5), being necessary to understand “harmonised standard” when used in the MDR and IVDR as “harmonised standard the reference of which has been published in the OJEU” (see point 1).

Actually, to be lawfully placed on the EU market, medical devices must comply with the health, safety and performance requirements of the applicable legislation, and not necessarily with the clauses of a standard. Conversely, 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), but not necessarily, unless the manufacturer would claim compliance with the legal requirements by using a harmonised European standard cited in the OJEU thus conferring presumption of conformity. 

The Court of Justice of the European Union (52) (European Court of Justice, ECJ) ruled on a number of cases related to specific aspects of European standardisation, with important consequences in the operation of the whole system, including for the medical devices sector.

The “James Elliott” case

On 27 October 2016, the ECJ pronounced a ground-breaking judgment with regard to standardisation, in the “James Elliott” case (53). With this judgment, the Court clarified the role and the legal quality of voluntary harmonised European standards adopted on the basis of standardisation requests issued by the European Commission to support Union harmonisation legislation. Notably,

(i) a harmonised European standard the reference of which is published in the OJEU forms part of the EU law;

(ii) the citation of harmonised European standards, as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012, in the Official Journal of the European Union (OJEU), has a legal effect and, as a consequence, is subject to the Court’s jurisdiction under Article 267 TFEU;

(iii) the development of standards is entrusted to organisations governed by private law;

(iv) the Commission has specific obligations and responsibilities to pursue the development process of harmonised European standards supporting European harmonisation legislation thoroughly, in particular while assessing them with regard to their compliance with the requirements set out in their respective legal acts and related standardisation requests, and the publication of their references in the OJEU.

Following the “James Elliot” case, the Commission adapted its internal procedures to improve legal certainty and transparency on harmonised European standards, and, as of December 2018, the Commission publishes their references as implementing acts in the “L series” (Legislation) of the OJEU, instead of communications in the “C series” (Information and Notices) (54).

The “Global Garden Products” case

In a judgment of 26 January 2017 on the “Global Garden Products” case (55), the General Court ruled, among others, that as long as the publication of a reference of a harmonised standard according to the old Directive 98/37/EC on machinery has not been explicitly repealed, the manufacturer of machinery conforming to this standard may continue to benefit from a presumption of conformity with the relevant essential health and safety requirements of Article 7 of the new Directive 2006/42/EC on machinery covered by this harmonised standard. This applies even if a new standard replaces the original harmonised standard.

Following the “Global Garden Products” case, the Commission systematically inserts, in the acts publishing in the OJEU references of harmonised standards in support of new EU legislation replacing old EU legislation, specific provisions on repeal of standards harmonised under that previous EU legislation.

The “Anstar Oy” case

In a judgement of 14 December 2017 on the “Anstar Oy” case (56), the General Court ruled, among others, that (i) the scope of a harmonised standard cannot be interpreted more broadly than that of the mandate [standardisation request] on which it is based; and (ii) if a harmonised standard does not indicate expressly that it is intended to replace another harmonised standard or one or more European technical assessments, those harmonised technical specifications remain in force and constitute special derogating rules.

The “Public Resource/Right to Know” case

On 14 July 2021, in its judgement on the “Public Resource/Right to Know case” (57), the General Court confirmed the legal standing of harmonised European standards the references of which have been published in the OJEU as “part of the EU law” as recognised by the “James Elliott” judgement, but clarified that such harmonised European standards are not EU legislation as such. With respect to availability of such harmonised European standards and specific aspects of the copyright on them, the European standardisation organisations (ESOs) are private, non-profit making organisations; it has not been established that there cannot be copyright on standards. Accordingly, at the time being, the ESOs can continue to claim a fee, i.e. selling those standards.

However, on 5 March 2024, the Court of Justice, in the appeal case (58), set aside the previous judgement and considered that “the European harmonised technical standards on the safety of toys should be accessible to EU citizens”, annulling the Commission’s decision refusing access to those standards.

The ” Stichting Rookpreventie Jeugd” case

On 22 February 2022, on the “Stichting Rookpreventie Jeugd” case (59), the ECJ concluded that a provision in EU law making an ISO standard mandatory without publication of that standard in the OJEU, does not infringe EU primary law, including the Charter of Fundamental Rights, nor the principle of legal certainty. In summary, the Court ruled with regard to the use of mandatory standards in EU legislation the following:

– the European legislator, while adopting legal acts, has wide margin of manoeuvre in the choice on the means to define the content of these acts which, however, must be precisely defined and understandable. Within this margin of manoeuvre, the European legislator is entitled to make use of mandatory standards within a legal act;

– an act of the Union cannot be enforced against individuals in a Member State before they have the opportunity to make themselves acquainted with it by its publication in the OJEU. In the absence of publication of a mandatory standard, the general public is not able to know its contents applicable to certain products;

– however, provided that companies have access to the official and authentic text of the standard made mandatory in the Union act, via the system established by ISO and its members whereby access to standards is ensured through the ISO national members, i.e. the respective national standardisation organisations, those ISO standards can be enforced against such companies.

The “Orona” case

On 13 September 2023, on the “Orona” case (60), the Court confirmed that a manufacturer is allowed to choose equivalent alternative solutions to those prescribed by harmonised standards the references of which are published in the OJEU. Actually, if only the implementation of safety measures identical to those provided for by such harmonised standards is considered to ensure compliance with the essential requirements laid down by EU legislation, this would have the consequence of preventing all alternative measures, however effective and safe as they are, and would hinder any technical innovation which is not in strict compliance with such harmonised standards. Furthermore, such harmonised standards represent the “state of the art” but are not necessarily to be taken into account unequivocally as “state of the art”, as it would depend on their contents and clarity with regard to compliance with the essential requirements.