The new article describes in detail the relevant harmonised standards applicable to medical devices, and also the way they should be applied.
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The Medical Device Coordination Group (MDCG) has published a revised guidance document dedicated to standardisation for medical devices. The document provides an overview of the applicable regulatory requirements based on the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, the MDCG reserves the right to make changes to the guidance and recommendations provided, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Legal References, European Standardisation Organisations, and Standardisation Mandates or Requests
According to the guidance, the EU legislation governing medical devices includes specific provisions related to harmonised standards and the presumption of conformity that their voluntary use can confer when their references are published in the Official Journal of the European Union (OJEU). These provisions are found in Articles 8(1) of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
These regulations define “harmonised standard” in reference to Article 2 of the Standardisation Regulation (EU) 1025/2012 as “a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation”. Importantly, the MDR and IVDR specify that harmonised standards refer to those whose references have been published in the OJEU, which directly links these standards to the presumption of conformity.
Harmonised European standards in healthcare engineering, including medical devices, are primarily developed by two European standardisation organisations (ESOs): the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). CEN covers most types of medical devices, while CENELEC focuses on medical electrical equipment.
Under Article 10 of the Standardisation Regulation (EU) 1025/2012, the European Commission can request these standardisation organisations to draft European standards or deliverables according to specific requirements. This legal basis is crucial for developing harmonised European standards that support EU legislation and allow their publication in the OJEU, which then confers a presumption of conformity with legal requirements.
Historically, standardisation requests were issued in the form of mandates under previous directives such as the AIMDD, MDD, and IVDD. However, with the current MDR and IVDR, the Commission now uses a more formalised approach through Commission Implementing Decisions.
These decisions are structured to include the rationale, objectives, activities, requirements, and timelines for developing standards. The standardisation request for the MDR and IVDR was adopted by the Commission on April 14, 2021, and accepted by CEN and CENELEC in May 2021.
This request, labelled M/575, is intended to be regularly updated to reflect ongoing standardisation work and innovation in the medical devices field. Amendments to this request were made in January 2023 (M/575 Amd 1) and May 2024 (M/575 Amd 2), which further refined and extended the validity of the standardisation request.
Development of Harmonised European Standards for Medical Devices and Assessment by HAS Consultants
The development of harmonised European standards for medical devices is carried out by CEN and CENELEC through their specific Technical Committees (TCs), based on the standardisation request for MDR/IVDR. This process follows a structured approach designed to ensure the highest quality of standards, with input from national and international experts, stakeholders, and interested parties.
During the development of these standards, the draft versions undergo specific assessments by Harmonised Standards (HAS) consultants. These consultants, who are technical experts supporting the Commission, evaluate the compliance of draft harmonised standards with the relevant EU legislative framework and the MDR/IVDR standardisation request.
This assessment is required by Article 10(5) of the Standardisation Regulation and is essential for ensuring that the standards meet the necessary technical and legal criteria. HAS consultants operate under the Commission’s direction and are managed by an independent contractor.
They provide reports at three key phases of the standardisation process: First Committee Draft, Enquiry, and Formal Vote. Their work is coordinated with regular exchanges of information and feedback sessions to ensure a consistent approach and effectiveness.
In the field of “Healthcare Engineering”, there are currently up to seven HAS consultants working on harmonised standards related to medical devices, managed by an external entity under a contract with the Commission.
Publication in the OJEU of References to Harmonised European Standards to Confer Presumption of Conformity
Once CEN and CENELEC complete the development of new or revised harmonised European standards, they propose the publication of these standards’ references in the OJEU to the European Commission. This publication process is crucial because it confers the presumption of conformity with the legal requirements that the standards aim to cover.
The Commission conducts a final assessment of these proposed standards, considering the HAS consultants’ reports and any additional information provided by CEN and CENELEC. The Commission then decides whether to publish, not to publish, or publish with restrictions the references in the OJEU.
This decision determines whether the standards will be officially recognised as conferring a presumption of conformity. Since December 2018, the publication of references to harmonised European standards in support of medical devices legislation has been formalised through Commission Implementing Decisions in the “L” series of the OJEU.
This robust legal format replaces the previous publication system, which was based on Commission Communications in the “C” series. This change was driven by the need for greater legal certainty and transparency in the standardisation process, as highlighted by the jurisprudence of the Court of Justice of the European Union.
International Aspects of Standardisation
Many European standards for medical devices are developed in parallel with international standards created by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). These parallel developments are guided by agreements such as the Vienna Agreement (1991) and the Dresden Agreement (1996), later confirmed by the Frankfurt Agreement (2016).
Under these agreements, the normative texts of the standards are largely the same, but harmonised European standards intended for publication in the OJEU must also include a “European foreword” and Annex(es) Z. These annexes link the standard’s clauses with the EU legislation’s requirements that the standard aims to cover.
The International Medical Device Regulators Forum also plays a significant role in guiding the development of international standards and their recognition at the regional and national levels. The IMDRF provides useful guidance on strategies, policies, and operational directions that influence the development of harmonised European standards for medical devices.
The Concept of “State of the Art”, European Standardisation, and Conformity Assessment for Medical Devices
The EU legislation on medical devices refers to the “state of the art” as a critical consideration for complying with health, safety, and performance requirements. However, “state of the art” is not a legally defined concept and involves dynamic and complex aspects that are difficult to encapsulate in a single definition.
It generally refers to the most recent and advanced stage of technical development, reflecting what is currently accepted as good practice in technology and medicine. Compliance with the “state of the art” is not synonymous with legal compliance.
While the most recent standards are often considered to reflect the “state of the art” compliance with these standards does not automatically ensure compliance with EU legislation unless further evidence is provided in the product’s technical documentation. The use of standards remains voluntary under EU harmonisation legislation for medical devices.
This means that manufacturers are not obligated to use any specific standard, even if it is considered to represent the “state of the art”. Instead, manufacturers retain the responsibility to ensure that their products comply with the relevant legal requirements, whether or not they choose to use harmonised standards.
The Rulings of the Court of Justice of the European Union on Standardisation
The Court of Justice of the European Union (ECJ) has ruled on several cases related to European standardisation, impacting the operation of the entire system, including the medical devices sector.
For instance, the “James Elliott” case of October 27, 2016, clarified the legal status of harmonised European standards. The Court ruled that harmonised standards cited in the OJEU form part of EU law and that their development, although entrusted to private organisations, carries legal obligations and responsibilities for the Commission.
Following this case, the Commission adopted its procedures, publishing references to harmonised standards as implementing acts in the “L series” of the OJEU. Other cases, such as “Global Garden Products”, “Anstar Oy”, “Public Resource/Right to Know”, and “Orona”, have further shaped the understanding and application of harmonised standards, particularly regarding their legal status, accessibility, and the flexibility manufacturers have in adopting alternative solutions.
European Pharmacopoeia
The MDR and IVDR also mention the European Pharmacopoeia in relation to harmonised standards, specifically for surgical sutures and interactions between medicinal products and device materials. While the European Pharmacopoeia monographs are not standards per se, they may confer a presumption of conformity when their references are published in the OJEU, similar to harmonised standards.
Common Specifications
The MDR and IVDR introduce the concept of “common specifications” as an alternative means of complying with legal obligations when harmonised standards are not available or sufficient. These specifications are legally mandated in specific cases, such as for products without an intended medical purpose and the reprocessing of single-use devices.
Common specifications serve as a fallback option, ensuring that manufacturers can still demonstrate compliance with legal requirements even in the absence of relevant harmonised standards. The adoption and use of these specifications are determined by the specific needs of the medical devices sector and the input from Member States and stakeholders.
Conclusion
In summary, the development, assessment, and publication of harmonised European standards are crucial to ensuring that medical devices comply with EU legislation. These standards provide a clear pathway for manufacturers to demonstrate conformity with legal requirements, although their use remains voluntary.
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