Harmonization of standards in the EU has been slow-going for several years. Medical device manufacturers are currently feeling the effects of this, particularly in the context of the EU regulation on medical devices (Medical Device Regulation, MDR, (EU) 2017/745). This replaced Directive 93/42/EEC on medical devices (Medical Device Directive, MDD) in 2021. However, there are still barely any standards harmonized with the regulation.
The fact that the EU has struggled with harmonization in recent years is due in part to two judgments from European courts: The “James Elliott Judgment” from the European Court of Justice (ECJ) from 2016 and the “Global Garden Judgment” from the European General Court (EGC) in 2017.
This article will:
Medical device manufacturers can use harmonized standards to demonstrate that their devices meet the requirements of legal regulations.
If the MDR requires a quality management system, manufacturers can use ISO 13485 as a guide.
Harmonized standards have been commissioned by the European Commission itself. Therefore, they are aligned with European regulations and recognized by public bodies.
EU Regulation 1025/2012 (Standardization Regulation) defines the term “harmonized standard” as:
“a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation”
When manufacturers use harmonized standards as a guide, there is a "presumption of conformity” with the legal regulation the standard is harmonized with.
The standards harmonized with a particular EU regulation are published in the Official Journal of the European Union.
Read more about the harmonization of standards in our article Harmonized Standards: Provision of Evidence for Medical Device Manufacturers.
You can see the latest version of the MDR in our blog post on the Medical Device Regulation MDR – Medizinprodukteverordnung (2017/745).
In recent years, however, the Commission has been publishing harmonized standards less and less frequently. Medical device manufacturers are feeling the effects of this, particularly in relation to the new MDR and EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). The MDR has been binding since 2021, while the IVDR will come into effect from 2022.
As of October 2021, the standards harmonized with both regulations relate almost exclusively to the sterilization of devices or biocompatibility. There have been a lot of efforts to expand this list. However, these procedures are being delayed.
The reasons for slow harmonization include conflicts between the EU and industry representatives, as well as between the EU, the European Committee for Electrotechnical Standardization (CENELEC, Comité Européen de Normalisation Électrotechnique) and national authorities.
There are also inconsistencies that affect individual standards such as ISO 14971. The EU Commission’s “HAS consultants” (Harmonized Standards Consultants) rejected its harmonization with the MDR, which leads to problems with the harmonization of standards that make normative reference to ISO 14971.
The two judgments, the James Elliott judgment (ECJ 2016, Case C-613/14) and Global Garden judgment (EGC 2017, Case T-474/15) also play a big role. These caused an uproar in the EU Commission and ultimately led to major changes (and a slowdown) in the harmonization process.
In its judgment dated October 27, 2016, the European Court of Justice (ECJ) established for the first time that harmonized standards are “part of EU law”. As a result, the case James Elliott Construction Limited against Irish Asphalt Limited (or the “James Elliott judgment” for short) marked a turning point for the development of harmonized standards in the EU.
Building contractor James Elliott sued his supplier Irish Asphalt Limited in the Irish Supreme Court for breach of contract. Irish Asphalt had agreed to supply the contractor building materials of “merchantable quality”.
This “merchantable quality” was defined in an Irish standard, which implemented the harmonized standard EN 13242:2002 (“Aggregates for unbound and hydraulically bound materials for use in civil engineering work and road construction”) at the national level. EN 13242:2002 had been harmonized on behalf of the Commission to the previous Construction Products Directive (89/106/EEC) and published in the Official Journal of the EU.
The interpretation of EN 13242:2002 became a key aspect of the dispute.
The Irish Supreme Court subsequently turned to the Court of Justice of the European Union (CJEU) for a preliminary ruling (Article 267 TFEU). In such proceedings, a national court refers certain questions concerning EU law to the CJEU because only the CJEU, not national courts, has jurisdiction to interpret European law.
The crux of the matter: until this case, it had not been clarified whether harmonized standards should be considered part of EU law and could, therefore, only be interpreted by the CJEU. As a result, for the question of whether the CJEU has jurisdiction, the Court had to comment on the nature of harmonized standards.
The ECJ declared itself competent and established that harmonized standards were, indeed, part of EU law.
The main arguments cited by the Court were:
The ECJ highlighted the Commission's control over the development of the harmonized standard.
The Commission mandated the European Committee for Standardization (CEN) to develop the harmonized standards. CEN is a legal organization governed by private law. It is, therefore, independent of the EU institutions. It could, therefore, be assumed that the EU is not responsible for acts by the CEN.
However, the ECJ emphasized in its judgment that the Commission exercised such control over CEN that it constituted a controlled delegation of standardization to a standardization organization governed by private law.
As a result, the Commission was responsible for standards developed by CEN.
The judgment is a specific decision on an individual case. In particular, in the James Elliott case, the implementation of the Construction Products Directive was dependent on the existence of harmonized standards. This is not the case with other EU regulations. Requirements can in most cases also be met using non-harmonized standards. Therefore, in this respect this is a special case.
However, CJEU case law is also relevant beyond individual special cases. This is especially true if the statements can be generalized and applied to other cases.
This is precisely the case in the James Elliott judgment. In it, the ECJ established above all that:
These statements apply independently of the Construction Products Directive. And they mean one thing above all for the Commission: harmonized standards can, in the worst case, represent a liability risk.
A European court once again made a judgment on harmonized standards in 2017.
In the judgment of January 26, 2017 (EGC Case T-474/15) from the European General Court (EGC), the main issue was the relevance of the publication of harmonized standards in the Official Journal of the European Union.
Again, the Court emphasized the “official” nature of harmonized standards published in this way and that the Commission must be measured against them.
Global Garden Products Italy SpA (GGP Italy) had placed a lawn mower, for which the company had demonstrated conformity with the Machinery Directive (2006/42/EC, and previously Directive 98/37/EC), on the market in 2012. For this demonstration of conformity, the manufacturer relied mainly on harmonized standard EN 60335-2-77:2006 (“Household and similar electrical appliances – Safety – Part 2-77: Particular requirements for pedestrian controlled mains-operated lawnmowers (IEC 60335-2-77:1996 [modified])”).
EN 60335-2-77:2006 had been harmonized with the old Machinery Directive 98/37/EC. However, this Directive had already been replaced in 2009 by its new version 2006/42/EC. The Commission was, therefore, of the opinion that standards harmonized with the old version 98/37/EC were not harmonized with the new version, 2006/42/EC, and would have to be revised.
This was then done for EN 60335-2-77:2006 as well. As early as April 2011, its successor EN 60335-2-77:2010 was published in the Official Journal of the EU. However, the Commission did not publish an expiry date for the previous standard, EN 60335-2-77:2006. It was not withdrawn until September 1, 2013.
Sequence of events:
Therefore, the question was: could Global Garden still use EN 60335-2-77:2006 between 2012 and September 1, 2013?
The EGC said it could and agreed with Global Garden. The Court ruled that:
The Court based its reasoning primarily on the James Elliott judgment by the ECJ and the general principle of legal certainty. Because of the far-reaching consequences, manufacturers have to be able to rely on the fact that the presumption of conformity with harmonized standards does not end “just like that.”
“Admittedly, the Commission’s interpretation does not create a legal vacuum, since the manufacturers and their representatives have means other than resorting to harmonised standards whose references have been published in order to conform with the essential health and safety requirements set out in the relevant directive with respect to the machinery that they wish to market. However, it must be noted that those other means are more onerous. Consequently, the Commission’s position does not contribute, at least during a certain period, to facilitating the free movement of goods in the internal market whilst ensuring a high level of protection of health and safety of users, as is required by the legal basis of Directive 2006/42, namely Article 114 TFEU.”
The statement is particularly interesting with regard to other EU regulations that are being replaced by more recent regulations and for which there are harmonized standards.
As with the ECJ’s James Elliott judgment, the EGC's Global Garden ruling can be said to be relevant beyond this specific case.
However, a careful review must be carried out in each case to ensure a comparable situation actually exists.
In addition, the main argument of the EGC was that a formerly harmonized standard had not been withdrawn. If a harmonized standard has been correctly withdrawn, it no longer justifies a presumption of conformity. According to the CJEU, this withdrawal must be notified by the publication of the “date of cessation of presumption of conformity” (“dow”).
In recent times, the Commission has been specifying an expiry date for the validity of the decision in the relevant provision on the validity of the request for standardization.
Nevertheless, the Global Garden judgment makes clear that the Commission must be very precise with regard to what it publishes in the Official Journal. It is bound by such publications. Manufacturers can expect legal certainty.
the absence of an implicit repeal of an act of general application resulting from its incompatibility with a later superior rule of law and where it is not stated, at the time of its publication, that it is of limited duration, the repeal of such an act may result from a new decision of the competent authority, which is itself published. It should be noted in that regard that the principle of legal certainty, which is a general principle of EU law, requires EU laws and regulations to be clear and precise and, in particular, that their application be foreseeable by those who are subject to them.”
All relevant European court decisions related to harmonized standards:
In the two judgments, the ECJ and EGC ruled that manufacturers can rely on harmonized standards and that the Commission is responsible for them, at least to a certain extent. And this is despite the fact that the standards are ultimately developed by an independent standards organization.
The James Elliott judging, in particular, has prompted the Commission to initiate several measures. In November 2018, it published a communication on harmonized standards that included a reference to the judgment. In it, the Commission announced three actions to “enhance transparency, reinforce legal certainty and speed of adoption”:
This guidance document was intended to complement the existing documents, the Blue Guide and the Vademecum. and to explain new features of the harmonization procedure as well as the role of the Commission and its appointed consultants (HAS consultants).
The consultation announced did not provide a consistent picture. In April 2021, the Commission published its new guidance.
As a result, the Commission has significantly expanded its review of standards through the new rules of procedure.
Based on the case law in particular, the Commission has changed its procedure for harmonizing standards. In 2020, a legal opinion commissioned by the German Federal Ministry for Economic Affairs and Energy (BMWi) established:
In addition, shortly after the James Elliott judgment, the Commission developed a checklist for an internal assessment procedure before the publication of standards.
“For example, the aim is to examine whether a standard is inconsistent in itself, does not in fact (fully) cover a particular requirement, or gives the user a choice that is not provided for in the relevant harmonisation legislation. Other questions, on the other hand, might indicate that the Commission also intended to claim, for itself or the consultants supporting it, a (selective) substantive-technical power of assessment from the end of 2016: one of the verification questions requires, in any case, in the event of a revision of a standard already published in the Official Journal, an assessment of whether the level of safety, interoperability, repeatability, reproducibility, etc. has deteriorated and disregards developments in the state of the art or the actual legal obligation. However, the assessment was only to be carried out relatively, i.e. in comparison with the previously published standard; here too, an original technical assessment was not provided for.”
This extended “preliminary assessment procedure” is probably also a reason for the delays in standard harmonization.
In particular, the (already problematic) new features in the MDR and IVDR now lack additional harmonization.
The fact that standards harmonized under the MDD should no longer be considered harmonized was confirmed by the Commission in its Implementing Decision (EU) 2020/437 of March 24, 2020. It states:
“The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745.”
The legal certainty for manufacturers required by the EGC, among others, is no longer guaranteed due to the lack of harmonization.
The expanded review by the Commission also makes it more likely to be liable for harmonized standards. This is because its liability extends as far as it exercises control over the procedure. More control, more liability.
“The European Union is not liable for damage resulting from errors in a harmonised standard itself. However, it may be held liable for decisions the Commission takes under the Standardisation Regulation that relate to standardisation requests, publication of references of harmonised standards in the Official Journal, or formal objections. The EU's responsibility for liability thus only goes as far as the Commission's assessment obligation goes.”
That this was the Commission’s goal is certainly open to doubt. In fact, the measures it has taken suggest that it actually would have liked to avoid liability for harmonized standards as well as the harmonization process.
The application of harmonized standards remains essentially voluntary. This means that manufacturers usually have to use other standards as well to demonstrate conformity with the requirements of a legal regulation. In practice, harmonized standards play an increasingly minor role.
However, without harmonized standards, there is no presumption of conformity. This could make it more laborious for manufacturers to provide evidence, which could in turn lead to delays and costs.
Furthermore, there is a lack of reliability, particularly in the case of standards that were previously harmonized but are no longer updated (and therefore have expired): if manufacturers use these as a guide, they often cannot be sure whether they still describe the state of the art.
The question of whether the Commission's response to the James Elliott judgment and the subsequent case law was sensible or necessary in its scope was one of the subjects of the legal opinion commissioned by the BMWi in 2020. The authors conclude that the Commission’s actions could, under certain circumstances, expand its liability and, therefore, delay harmonization.
“Against this background, the recent tendency of the Commission to interpret its assessment obligations widely bears a certain risk with regard to liability rules.”
“[...] The resulting delays in the publication even of positively assessed standards have already occurred, as data from CEN/CENELEC shows.”
It is, therefore, reasonable to assume that the Commission's reaction is the result of a misinterpretation of the case law. The communication on harmonized standards it published in 2018 lends more weight to this assumption. In it, it expressly states that it interprets the James Elliott judgment as requiring it to expand its assessment obligations:
“The Commission has thus the obligation to follow the development process of harmonised standards thoroughly and to assess whether they comply with the requirements set out in harmonised Union legislation and/or standardisation requests in order to ensure that harmonised standards fully comply with the applicable legislation. This does not only include the technical aspects of standards but also other elements of the European Standardisation Regulation, such as whether their development process has been inclusive. It is the Commission’s intention to fulfil these obligations in a manner which is as swift and efficient as possible.”
Source: EU Commission, communication on harmonized standards
In contrast, the legal opinion comes to the opposite conclusion that ECJ case law does not the Commission having such an obligation.
“This is evidently not linked to a request to the Commission to extend its assessment of harmonised standards.”
Source: Dingemann/Kottmann, legal opinion commissioned by the BMWi
This contradicts both the spirit and purpose of commissioning a largely independent standards organization to develop standards and the James Elliott judgment itself. Therefore, standards can only be considered as “part of EU law” in the context of preliminary rulings according to Art. 267 TFEU.
“Secondly, classifying harmonised standards as "genuine" Union law would necessarily mean that all requirements and characteristics of Union law – such as its general primacy over all conflicting national laws – would apply to them. Again, it is clear that the Union legislator did not intend this. It would also conflict with the James Elliott judgment itself. In it, the ECJ precisely does not assume a general precedence of harmonised standards over the laws of the Member States because the provisions of the national laws on contracts for the sale of goods can impose requirements relating to the usability of products that diverge from said standards.”
Source: Dingemann/Kottmann, legal opinion commissioned by the BMWi
An overly detailed review by the Commission, particular a detailed technical verification of the harmonized standard developed by the standardization organizations would also contravene Article 10(5) and (6) of the Standardization Regulation.
“In particular, it would be contrary to the nature and purpose of the New Approach [includes commissioning of standardization organizations to develop harmonized standards; editor’s note] if the Commission, with the help of HAS Consultants, was ultimately able to duplicate the standardisation process and substitute its assessment for that of the standardisation committees.”
Source: Dingemann/Kottmann, legal opinion commissioned by the BMWi
How far the Commission's duplication of the standardization process goes under the EU's new guidance is not clear from the document. The guidance merely states in this regard:
“Harmonised Standards (HAS) consultants”, as technical experts supporting the Commission services, to ensure the compliance of the draft harmonised standards with the relevant EU legislative framework and with the relevant standardisation request (mandate).”[...]
“Their activities are based on the rules on European standardisation and on specific procedures, guidance documents and templates, to carry out the necessary technical and legal assessments and to provide reports to the Commission at three specific phases of the standardisation development process (the so-called milestones: First Committee Draft, Enquiry and Formal Vote).”
However, based on what has been said so far, another expansion of the Commission's review would be problematic.
Based on what we suspect to be a misinterpretation of the James Elliott judgment, the Commission changed its standard harmonization procedure a few years ago and has significantly expanded the scope of its assessment. This, in addition to other factors, is now probably leading to delays in harmonization.
As a result, rather than fulfilling a supposed obligation, the Commission is neglecting its duties, namely the duty to create legal certainty for manufacturers through harmonized standards and thereby to ensure, among other things, the safety of products and the free movement of goods.
Hopefully, this will change again soon. However, it does not currently look like this problem will be solved quickly.