Standards and the state of the art for medical devices regulation

EU MDCG develop guidance on standardization for medical devices

The Medical Device Coordination Group (MDCG) is composed of representatives of Member States and chaired by the EU Commission. The MDCG has issued a guidance document on standardization for medical devices. As with all the MDCG guidance, it cannot be regarded as reflecting the official position of the European Commission, or as being legally binding.

The guidance covers a range of topics on standardization and the harmonization of standards to provide a presumption of conformity with European regulatory requirements. One interesting area of the document relates to the frequently discussed relationship between standards and the state of the art.

The requirements for medical devices in the EU, in both the medical devices Directives and Regulations, refer in a number of places to the need to “take into account the generally acknowledged state of the art” in relation to safety and performance of medical devices. The guidance stresses that saying “taking into account” is different to stating “comply with”. The guidance goes on to indicate that the state of the art is not legally defined and is difficult to express in a single, clear definition. This is because the term involves several complex aspects. The guidance indicates that it is useful to consider different sources where the term is defined or explained, even if the definition is not legally binding. Two such definitions of “state of the art”, with a lot of similarity, are from:

• International Medical Devices Regulators Forum (IMDRF) (IMDRF/GRRP WG/N47) - developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience.
• BS EN ISO 14971:2019 - 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.

The minutes of a meeting of the MDCG indicate that the most recent published editions of standards should be considered as reflecting state-of-the-art, regardless of whether or not they are referenced in the Official Journal of the European Union. The guidance extends this discussion to indicate compliance with the most recent version of a standard does not automatically imply compliance with the requirements of the applicable EU legislation. Furthermore, the use of standards is voluntary. Therefore,  it is not possible to impose the use of a specific standard in the conformity assessment of a product, not even on the basis of “compliance with the state of the art”.  The manufacturer needs to have evidence of how the device meets the regulatory requirements in the technical documentation of the product. The guidance clearly states that while a notified body has to check whether device complies with the requirements of the Directives or Regulations on medical devices, it cannot make conformance with any particular standard mandatory. Manufacturers can find it useful to discuss with their notified body how they will review technical documentation with regard to the state of the art and references to standards.

The manufacturer has the choice whether or not to use a standard within its responsibility for the legal compliance of products intended to be placed on the market.  The manufacturer also needs to be able to demonstrate how they have “taken into account” the state of the art. This suggests that manufacturers should give consideration to the latest version of a relevant standard, even if it is not harmonized.