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Our Latest Publication:    November 2026 – Volume 23, Issue 4
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Reconceptualising ‘well-established technology’ in the EU’s Regulation on medical devices

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Examine how the EU’s new well-established technology concept could shape medical device conformity assessments, and why a more nuanced, evidence-based interpretation is needed

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English

Abstract:

The concept of ‘well-established technology’ (WET) has recently assumed increased significance within the European Union (EU) through its regulatory recognition in Commission Delegated Regulation (EU) 2026/1359. This development introduces a device-type-based classification with direct consequences for conformity assessment requirements. In this article, Haroon Atchia critically examines the epistemic structure underlying WET, arguing that it uses a simple model of evidential sufficiency that reduces complex, multi-dimensional evidence to binary regulatory decisions.
Drawing comparisons with EU equivalence doctrine and US substantial equivalence under the 510(k) pre-market notification requirements, the article demonstrates that these approaches, while operationally effective, share a common limitation: they do not adequately resolve attribute-level variability, evidential weighting or temporal dynamics. The article concludes that WET, as currently formulated, constitutes an administratively useful but epistemically loose proxy and proposes a more structured, attribute-sensitive interpretation to support future regulatory development.

 

Learning objectives:

  • Understand the legal and regulatory basis of ‘well-established technology’ under the EU Medical Devices Regulation.
  • Examine the epistemic assumptions underlying the WET classification.
  • Critically evaluate the use of aggregated or scalar assessments of evidential sufficiency.
  • Analyse the implications of attribute-level variability, evidential weighting and temporal change for WET determinations.
  • Compare WET with EU equivalence and US substantial equivalence frameworks.
  • Assess the case for a more structured and attribute-sensitive approach to regulatory classification.

 

About the author:

Haroon Atchia is Technical Director at Quality First International, London, UK and a recognised international expert in US and European medical device regulations. He is also a leading expert in compliance remediation, regulatory due diligence, market surveillance and clinical evaluation. Mr Atchia is a Senior Associate member of the Royal Society of Medicine, Member of the Society of Corporate Compliance and Ethics, Medical Devices Lead Assessor, Journal of Medical Device Regulation Editorial Advisory Board member, microbiologist, cardiovascular, blood contact and non-active implantable device specialist, plastics technologist and Expert Witness. He also serves as a Member of the ASTM Committee F04.

 

Specification:

6 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the November 2026 issue of the Journal of Medical Device Regulation.

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