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Medical Apps & Medical Software

We develop medical apps

Looking for support in the development of your medical software or app?
For 14 years, we have specialized in the design and implementation of software solutions. For the pharmaceutical and medical technology sectors, we implement software projects in accordance with the applicable regulatory standards: IEC 62304, ISO 14971 and IEC 60601-1-6 / EN 62366. Our focus is the development of mobile applications for iPhone, iPad, Android Phones and Tablets, and Windows Mobile devices. Accordingly, we support you in all product lifecycle phases:

  • Requirements Engineering
  • Risk Management
  • Software Engineering
  • Usability Engineering
  • Testing
  • Rollout
  • Release in App Stores
  • CE marking, FDA approval
  • Post-market observation

We plan, develop, test, and document medical apps to your specifications, in accordance with applicable regulatory requirements for medical devices.

Want to market your medical app?

In Europe, a conformity assessment procedure must be carried out prior to putting a medical app on the market, which confirms compliance with all relevant requirements. These include requirements for documentation, the process of software development, software testing, software validation (EN 62304), suitability for use (IEC 60601-1-6 / EN 62366), risk management (ISO 14971), version management, and, depending on the particular app, possible further specific requirements such as IEC 80001 ("risk management for medical IT networks").
We can assist you in marketing your medical app. As the developer of the world’s leading software solution for creating technical documentation for medical equipment and in vitro diagnostic devices - Qware® Riskmanager - we can aid you in quickly and cost-effectively preparing the necessary documentation for approval.

Shifting product features into software

There is a trend of shifting product features into software, which can also be observed in medical technology. Software has then become an ever-growing part of medical technology. This article first tries to explain the concept of software and then to discuss the legal classification of software according to the principles of medical device legislation. Here the question of particular interest is whether software is to be considered as a medical device on its own, or as a component of a medical device. Other matters which arise are the correct classification, and compliance with the regulation on the installation, operation and application of medical equipment (the Medical Device Operator Provision - MPBetreibV).


Overview

What is software?

To date, the term software is not uniformly or especially unambiguously defined. One approach to the search for a legal definition is from the perspective of copyright. According to this, software is the popular term for computer programs of all kinds. According to §§ 2 Nr. 1, 69a Abs.1 of the Copyright Act, computer programs are protected by copyright as literary works. Wikipedia describes software likewise as a program and quotes Tessen Freund’s Software Engineering durch Modellierung wissensintensiver Entwicklungsprozesse (Software Engineering Through Modelling Skill-Intensive Development Processes): "In software technology, software consists of computer programs of every nature, from source code to directly executable machine code."

In the context of medical technology, the term software is rarely described. Considering 3.12 of the EN 62304: 2007 "Medical device software - software life cycle processes," one is given to understand that medical software is a software system that has been designed to be integrated into a design-specific medical product or is intended for use as a separate medical product.
The FDA describes software in the “Glossary of Computer Systems Software Development Terminology” as “(ANSI) Programs, procedures, rules, and any associated documentation pertaining to the operation of a system. Contrast with hardware. See: application software, operating system, system software, utility software.”

In summary, one could say that software is a copyrighted literary work, consisting of computer programs of every nature, from source code to directly executable machine code, and is not hardware.

Is software a medical device?

We consider Directive 93/42/EEC. This defines a medical device:

“any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:


    diagnosis, prevention, monitoring, treatment or alleviation of disease,
    diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
    investigation, replacement or modification of the anatomy or of a physiological process,
    control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”.

Also the proposal of the European Parliament and of the Council concerning medical devices and amending Directive 2001/83/EC, Regulation (EC) No. 178/2002, and Regulation (EC) No. 1223/2009, mentions the concept of software in its definition of “medical devices”: “‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of:

diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,

investigation, replacement or modification of the anatomy or of a physiological process or state,

control or support of conception,

disinfection or sterilisation of any of the above-mentioned products,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means”.

The definitions of accessory and "active devices" are important in this context:
"Accessory of a medical device" means an object which itself is not a medical device, but is intended by the manufacturer to be used together with a particular medical device or with particular medical devices, and enables or supports the intended operation of the device or devices.

"Active device" means a device which depends on a source of energy for its operation, where this source is a source of electricity or another energy source with the exception of energy directly generated by gravity, and which functions by changing density or converting energy. A product that is used to transmit energy, substances or parameters between an active device and the patient, without causing a significant change in the energy, substances, or parameters, is not considered an active product.

Standalone software is considered an active medical device

Software is therefore treated as a medical device in exactly the same way as "proper" devices or equipment, provided that the specified definitions apply. This entails that the software manufacturer must check whether the intended use of the product meets this definition. (In the context of “medical purpose”, it is worth reading the presentation of Case BGH I ZR 53/09 to the European Court of Justice and the ECJ judgment on Case C-219/11.)

 

Integrated versus standalone software

The prevailing legal norms differentiate standalone software from integrated software. If the software is a "finite element" of a medical device, it is therefore consider integrated into the medical device and the device with software is put on the market as a single unit. As such, the software does not receive an independent CE mark within the meaning of § 6 para. 1 of the MDD, and no separate conformity assessment procedure is carried out for the software in isolation. That is to say, compliance for the software is checked as part of the conformity assessment procedure for the main product.

If the software is an independent medical device (stand-alone software), it should not be put on the market without a corresponding CE marking, which requires a separate conformity assessment procedure. The requirements for this procedure depend on the risk category to which the software is to be assigned. The classification rules can be found in Annex IX of the Medical Device Directive.
Risk classes indicate the risks due to a product: the higher the risk category (I, Is, Im, IIa, IIb, III), the higher the assessment of the risk of the product, and, correspondingly, the higher the standards for evidence that the product complies with the requirements of the Medical Device Directive. As laid out above, software is considered an active medical device if the manufacturer assigns a medical purpose to it.

Non-binding guidance on clarifying whether particular stand-alone software is considered to be a medical device can be found in the MEDDEV guide „MEDDEV 2.1/6 GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND-ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES“.

In the guide there are two decision diagrams for medical devices under the IVDD and MDD. With this, operators and manufacturers can deduce whether particular software for example is subject to the MDD. There are also examples of software that can be used for diagnosis and therapy.

“It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Stand-alone software for general purposes when used in a healthcare setting is not a medical device."

 

Conclusion

The following conclusions can be drawn from the requirements of the directive and the MEDDEV document:

  • Software that is marketed as a medical device on the market must have an unambiguous purpose
  • Software that is not intended as a medical device for diagnosis and treatment must likewise have an unambiguous purpose
  • Software without purpose and without classification may not be used for diagnosis and therapy (unintended use)

For software with various clearly distinguishable modules, its individual modules with unambiguous purpose can, according to MEDDEV 2.1/6, also be classified as medical devices. This means that stand-alone software can consist of both parts which are themselves medical devices and parts which are not considered to be medical devices. It is important that there is a clear delineation of these "medical device modules" from the rest of the software. If this is not possible unambiguously or would not be unambiguously carried out, then all the software is considered a medical device and classified as such. This has consequences beyond the impact on the approval process mentioned above.
For software classified as a standalone medical device, the provisions of MPBetreibV must be observed. This means that the software may only be operated, applied, and maintained by persons who have the required training or knowledge and experience (§ 2 para. 2 MPBetreibV). In addition, users must observe the instructions as well as safety-related information and messages during operation, and they have to verify that the software is correctly installed and configured (5 p §2. 1 MPBetreibV).

 

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