On 25 May 2017, Regulations EU 2017/745 for medical devices (MDR) and EU 2017/746 for in vitro diagnostic medical devices (IVDR) came into force. The transitional periods for the two regulations expired on 26 May 2021 and 25 May 2023. The MDR and IVDR are now solely valid and the MDD or IVDD can only be used for legacy devices, and only to a limited extent. During the transition period, many current processes had to be adapted to the new requirements of the MDR and IVDR. However, there were no harmonised standards at the time, which made it particularly difficult for manufacturers to establish a presumption of conformity and take the state of the art into account.
What are harmonised standards and why do we need them?
Harmonised standards are European standards that are published by the organisations CEN, CENELEC and ETSI on behalf of the European Commission and EFTA with the aim of facilitating the free movement of goods and services in the European internal market. These can be revised and newly issued national (e.g. DIN, ÖNORM, SN…) or international (ISO…) standards, but also specifically newly developed European standards. In order to obtain the status “harmonised”, the relevant standards must be published in the Official Journal of the European Union.
A key feature of European standards is the precise definition of requirements that are directly related to European legal acts. This relationship means that conformity with the legislation can be assumed if the respective standard requirement is fulfilled. For this purpose, the Z annexes of the standards usually contain a reference table that assigns the requirements in the individual standard chapters to the relevant sections of the European regulations. In the case of the Medical Devices Regulation (EU) 2017/745 or the Regulation on in vitro diagnostic medical devices (EU) 2017/746, reference is made to the essential safety and performance requirements. As part of the “new approach“, harmonised standards therefore serve to develop technical details and solutions to support the essential requirements that are generally formulated in the respective regulations.
What is the status of harmonisation of relevant standards for medical devices and in vitro diagnostics?
In June 2019, the EU Commission published the first draft of a standardisation request to CEN / CENELEC. This included over 180 standards for harmonisation under MDR and IVDR, which should be completed by October 2024. A consolidated version of all standardisation requests has been available since April 2021 and includes over 250 standards, most of which are to be harmonised by May 2028. It is to be expected that such harmonisations are complex, especially as the respective state of the art is also likely to play a role here. Nevertheless, the number of harmonised standards is sobering. As of November 2024, only 26 standards have been harmonised under the MDR and 15 under the IVDR. The most recent addition was EN ISO 13408-1:2024 for aseptic manufacturing of healthcare products in October 2024.
The responsibility therefore currently remains with the manufacturers to be able to provide a good justification, by means of a critical assessment of the selected standards, as to why a standard that has not yet been harmonised is suitable for fulfilling the essential requirements. This applies in particular to vertical, product-related standards and less to horizontal standards.
But even after harmonisation of a standard, many manufacturers are still faced with another question, namely…
What does it mean to comply with the “state of the art” if the latest edition of a standard is not harmonised?
In order to answer this question, it is first important to realise that the concept of the state of the art is not uniformly defined and must therefore be considered from different perspectives. The MDCG assesses the state of the art as follows:
” The most recent editions of standards published by the standardizers should be considered as reflecting stat-of-the-art, regardless of the OJ referencing”
In other words, it is not the harmonised standard that represents the state of the art, but the latest edition of a standard.
However, EN ISO 14971:2019 states:
“Developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience”
This definition offers a much calmer view on the state of the art, but this does not make the task any less complex.
The MDCG 2021-5 “Guidance on standardisation for medical devices”, which was revised in July 2024, provides further definitions that can be used here.
But to what extent is this guideline relevant at all? After all, the introductory words of the MDCG Guidances always read:
“Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.”
So can manufacturers ignore the guidance in good conscience? The aforementioned MDCG 2021-5 and Article 1 of the MDR also provide important insights into this:
“[…] taking into account the state of the art and in particular existing harmonised standards […]“
To be taken into account, but not to be complied with. If the manufacturer does not (yet) intend to apply the standard, this should be documented. This is because, regardless of whether it is a harmonised standard, a standard outside of harmonisation or relevant guidance documents, the discussion will come back to the notified body at the latest. The following is imposed on them within Annex VII point 4.5.1:
The notified body shall, 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.
Therefore, the notified body is obliged to ask and will expect an answer from the manufacturer.
How can gaps in the presumption of conformity be closed?
In order to be able to satisfactorily demonstrate fulfillment of Annex I, i.e. the general safety and performance requirements, and to establish a presumption of conformity, it is important that manufacturers take into account both the harmonised standards and the state of the art. If not all general safety and performance requirements can be sufficiently demonstrated, other standards and guidelines should be considered in addition to the harmonised standards. It is important here that the application of the guidelines or standards is explained in a comprehensible manner. Solutions developed by the manufacturer himself can also be used but must then explain why they are equivalent to available standards or why they are suitable for closing the respective gap.
The partial application of a standard is also possible here. However, with regard to the Blue Guide, which can be understood as a guide to implementing the New Approach, manufacturers should take this into account:
A clear distinction must be made between ‘conformity with a standard’ and ‘presumption of conformity (when applying (188) a harmonised standard)’. Conformity with a standard’ usually makes a reference to a situation where a standard is ‘fully applied’. This is for instance the case of voluntary certification against a standard. For the purposes of ‘presumption of conformity’ it is sufficient to apply only those provisions relating to the essential or other legal requirements aimed to be covered.
The indication within the general safety and performance requirements and on the product labelling, in the technical documentation and in the declaration of conformity as to whether a standard has been applied in full or only in part is therefore relevant for both harmonised and non-harmonised standards, albeit from different perspectives.
What does all this mean in concrete terms for the standards pending harmonisation? Well, one can assume that the series of standards themselves, which are listed in the consolidated harmonisation request from 2021, are still relevant. With a view to the state of the art from the MDCG’s perspective, it is worth reviewing these and focusing on the latest edition of the respective standard. In addition, relevant MDCG Guidances on the respective subject areas should be taken into consideration. Finally, it is important to briefly explain the relevance of the respective standards for your own product and to clarify whether a standard has been applied in full or only in part. And always be prepared for questions from the notified bodies.
Do you still have questions about your specific case? We will be happy to help and advise you.
Please note that all details and listings are not intended to be exhaustive, are without guarantee and are for information purposes only.
