The MEDDEV guidance document addresses all of the medical device directives and includes two decision trees to determine whether software is regulated under the Medical Devices Directive or In Vitro Diagnostics Directive.
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| The decision tree is designed to assist manufacturers in the qualification of stand-alone software as an IVD device. |
The European Commission recently published “Guidelines on the Qualification and Classification of Stand Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices.” The MEDDEV guidance document addresses all of the medical device directives and includes two convenient decision trees to determine whether particular software is regulated under the Medical Devices Directive (MDD) or In Vitro Diagnostics Directive (IVDD).
The decision tree for IVDs is mainly concerned with demarcation of the MDD and the IVDD, notes Erik Vollebregt, a founding partner of Axon Lawyers, a boutique law firm based in Amsterdam that focuses entirely on the life sciences industry. “The IVDD typically regulates expert systems that interpret data from IVD devices. If the data come from diagnostic devices that are covered under the MDD but not under the IVDD (because the data are not derived from in vitro examination of a specimen derived from the human body), the software falls under the MDD and not under the IVDD,” says Vollebregt. He co-authored an article [7] on stand-alone medical software, with a detailed analysis of the MEDDEV document, on emdt.co.uk. A portion of the article that addresses IVD-related issues is excerpted here.
For clinical decision support (CDS) software to fall within the scope of the IVDD, the manufacturer’s intended use must be the examination of in vitro specimens derived from the human body (including blood and tissue donations) solely or principally for the purpose of providing information concerning a physiological or pathological state or congenital abnormality; to determine the safety and compatibility with potential recipients; or to monitor therapeutic measures.
CDS software with other functionality that is also not an accessory of an IVD falls outside the scope of the IVD Directive. (Accessories of medical devices are regulated as medical devices in their own right.)
Determining the sources of data is an important step in the decision tree. If the data come from any source other than an IVD, there is a demarcation issue because the device concerned is a combination device. Combination devices are contemplated in the IVDD: if the IVD is intended for use in combination with other (medical) devices or equipment, the whole combination, including the connection system, must be safe and must not impair the specified performance of the devices. Any restrictions on use must be indicated on the label and/or in the instructions for use.
If the software obtains the data only from one or more medical devices that are not IVDs, the IVDD does not apply and the software is regulated under the MDD.
The MEDDEV also regulates software that is a module of a larger interoperable software package that falls within the scope of the MDD or IVDD. However, it is up to the manufacturer to define correctly the boundaries of the module(s) and to identify clearly what is regulated and what is not. The MEDDEV does not provide guidance on how to make such a determination but instead refers to the existing rule in Annex I MDD and IVDD for combination devices: “If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system, must be safe and must not impair the specified performance of the devices. Any restrictions on use must be indicated on the label and/or in the instructions for use.”
Looking ahead. The European Union is currently in the process of preparing a first draft review of the MDD, which will probably be a single regulation that incorporates both directives. The IVDD also will be reviewed but will not be incorporated in the same regulation. “Sources close to the process, however, confirm that the new IVD document also will be a regulation and will closely mirror the regulation for medical devices,” says Vollebregt.
This review process will take time and the new legislation probably will not go into effect before 2015, at the earliest. We mention this development, though, because the new legislation probably will impact clinical decision support software in the following ways:
• In terms of scope, more diagnostics will be covered under the MDD. The European Union intends to include within the scope of the new regulation genetic tests for lifestyle purposes and diagnostic services provided at a distance.
• The requirements for clinical validation of CDS software will become stricter. Specifically for IVDs, the European Union is contemplating evaluation of clinical validity and utility of IVDs. As suggested above, CDS software associated with an IVD would be subject to these requirements.
• The requirements for postmarket surveillance of CDS software will be harmonized and streamlined, as they are currently largely member-state focused.
• The European Union will impose further traceability requirements and probably will start a registry for the publication of summary information for higher-risk devices, as is currently mandated by FDA.