BfArM - Federal Institute for Drugs and Medical Devices
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Differentiation and classification
Medical devices are assigned to risk classes. With the exception of in-vitro diagnostics, medical devices are classified according to the classification rules in Annex VIII MDR. The products are divided into four classes I, IIa, IIb and III, with class III being the highest risk class. In vitro diagnostic medical devices are categorised into classes A, B, C and D in accordance with Annex VIII IVDR. Class D represents the highest risk class.
The classification of a product as medical device (differentiation from other products) is determined by the manufacturer by means of the intended purpose, which results from details of labeling, instructions for use and advertising materials. The definition for medical devices according to Article 2 No. 1 MDR shall be fulfilled.
Likewise, the manufacturer or his authorized representative is responsible for the classification of the product. The classification is carried out according to the classification rules of Annex VIII of the MDR. The intended purpose of the product, as determined by the manufacturer, is also important here. The classification is therefore always determined for a concrete, individual product.
For decision-making, further sources can be consulted, such as the MEDDEV documents of the European Commission, which can be accessed at: http://ec.europa.eu/health/medical-devices/documents/guidelines/ (area 2.1 "Scope, field of application, definition" as well as area 2.4 "Classification of MD", for in vitro diagnostic devices also area 2.14 "IVD" and for software the MEDDEV 2.1/6).
The "Manual on borderline and classification in the Community Regulatory framework for medical devices" of the European Commission is also helpful when making decisions on the demarcation of medical devices from other products, which you can access at:
The Federal Institute for Drugs and Medical Devices (BfArM) does not have a list of product classifications of medical devices marketed in Europe. Likewise, unfortunately, no blanket decisions can be made on entire product groups, as the risk classification always depends on the individual intended purpose and the corresponding information provided by the manufacturer.
In general, medical devices in Europe are placed on the market largely under the responsibility of the manufacturer. Medical devices must be subjected to a conformity assessment procedure by the manufacturer, which may require the involvement of a Notified Body, depending on the device’s risk class.
In Germany, the supervision of the manufacture, placing on the market and circulation of medical devices (including operation and use) and the implementation of the Medical Devices Implementation Act and its ordinances in this regard is the responsibility of the state authorities (“Landesbehörden”).
Lists of Notified Bodies, competent state authorities in Germany and the competent authorities of the other EEA member states can be accessed on the Competent Institutions website.
Criteria of differentiation/classification
Manufacturers of medical devices, their authorised representatives, state Competent Authorities responsible for the manufacturer and their Notified Bodies are entitled to apply in accordance with § 6 Para. 2 of the Medical Devices Implementation Act (MPDG).
The intended purpose of his product shall have been clearly defined by the manufacturer before submitting the application. The applicant has familiarised himself with all literature available to him on differentiation or classification.
If this also does not lead to clarification, there is the possibility of submitting an application for classification and/or differentiation according to § 6 Para. 2 MPDG to the federal Competent Authority BfArM. All documents relating to the product shall be enclosed with this application.
It is necessary that the applicant makes an assessment with reasons on the question of differentiation or classification of the product and attaches it to the application. Existing correspondence with the state Competent Authority, another authority or a Notified Body shall be attached to the application.
Application for classification and/or differentiation
For a differentiation or classification decision by the federal Competent Authority BfArM, an informal application for classification and/or differentiation according to § 6 paragraph 2 MPDG must be submitted to the BfArM. In principle, a German Notified Body, the manufacturer, his authorized representative or the responsible state Competent Authority are entitled to submit an application.
Software applications for cell phones and tablets, so-called "apps", have become everyday companions in work and leisure. In the health care sector, too, the number of apps on offer has increased rapidly in recent years. Apps measure our fitness, provide health tips, analyze physiological data and calculate the dosage of medications.
Where is the boundary between wellness application and medical device? How can developers tell whether their product is subject to the scope of the MDR and the corresponding regulations? What do you have to do in this case?
In the following, the BfArM would like to provide guidance on the differentiation of apps (generally: standalone software, i.e. software that is not an integral part of another medical device, e.g. as control software) between medical device and other products and on the subsequent risk classification.
At this point, only references and hints can be given. The decision regarding the delimitation and classification, which is to be made based of the intended purpose of the software, is the responsibility of the manufacturer, as is the placing on the market, respectively in coordination with a Notified Body, if necessary.
The guidance is also intended to support considerations in the run-up to an application to the BfArM in accordance with § 6 Paragraph 2 MPDG. The manufacturer of the software, his authorised representative, the state Competent Authority responsible for this manufacturer and, if applicable, the Notified Body involved in the conformity assessment procedure are entitled to submit an application. You can find more information on submitting applications here .
1. Differentiation/Qualification
In accordance with Section 3 number 10 MPG, the intended purpose is the use for which the medical device is intended according to the manufacturer's information on labelling, instructions for use or promotional materials. Thus, not only the explicitly described intended purpose is relevant e.g. for an authority decision on qualification as a medical device, but also the instructions for use and the promotional materials (e.g. website, information in App Store) regarding the specific product.
Stand alone software like smartphone apps can indeed be classified as a medical device. In order for this to be the case, the software must be intended by the manufacturer to be used for humans and for at least one of the following purposes pursuant to Section 3 number 1 MPG:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation or compensation of injuries or handicaps,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception.
As opposed to mere provision of knowledge, e.g. in a paper or electronic book (no medical device), any type of interference with data or information by the stand alone software is indicative of a classification as a medical device.
Possible indicative terms in connection with the intended purpose of corresponding functions can be e.g.: alarm, analyse, calculate, detect, diagnose, interpret, convert, measure, control, monitor, amplify.
Indicative functions for classification as a medical device can be among the following:
decision support or decision making software e.g. with regard to therapeutic measures
calculation e.g. of dosing of medicines (as opposed to mere reproduction of a table from which users can deduce the dosage themselves)
monitoring patients and collecting data e.g. by measurements if the results thereof have an influence on diagnosis or therapy.
Pure data storage, archiving, lossless compression, communication or simple search functions do not result in classification as a medical device.
Note: Declarations e.g. a statement in the App Store "This is not a medical device" do not circumvent the afore-mentioned criteria and are not considered in the BfArM's decisions pursuant to Section 13 MPG if an intended medical purpose is stated or implied by the manufacturer in labelling, instructions for use or promotional materials.
Like all other medical devices from own production, software applications from own production are medical devices and thus must fulfil the basic requirements of Council Directive 93/42/EEC. This includes accessories manufactured and used in a health facility without being placed on the market or fulfilling the prerequisites of a custom-made device pursuant to Section 3 numbers 21 and 22 MPG.
2. Risk classification
With the exception of in vitro diagnostic medical devices and active implantable medical devices, medical devices are allocated to risk classes that are mainly based on the potential damage that can be caused by an error/malfunction of the medical device. These risk classes range from Class I (low risk) and IIa and IIb to Class III (high risk). Class I products are additionally subdivided according to whether they require sterilisation (Is) or include a measuring function (Im) which is relevant for the further conformity assessment procedure.
The classification is based on the rules laid down in Annex IX of Council Directive 93/42/EEC. The following rules are most suitable for the classification of stand alone software:
Rule 9
"All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb.
All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb."
Rule 10
"Active devices intended for diagnosis are in Class IIa,
if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum;
if they are intended to image in vivo distribution of radiopharmaceuticals;
if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.
Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb.“
Rule 12
"All other active devices are in Class I."
Rule 14
"All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, …"
Implementing rule 2.3
"Software, which drives a device or influences the use of a device, falls automatically in the same class."
The following definitions in accordance with Annex IX Section I No. 1 of Council Directive 93/42/EEC are to be observed:
Stand alone software
Stand alone software is considered to be an active medical device.
Active therapeutical device
"Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap."
Active device for diagnosis
"Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities."
The afore-mentioned rules show that e.g. medical apps on smartphones and tablets will mostly be classified in risk Class I in accordance with Rule 12. If the medical devices are intended for diagnosis or monitoring of vital functions (e.g. cardiac functions), Classes IIa or IIb can also be considered.
Depending on the risk class there are different requirements for conducting a conformity assessment procedure as the prerequisite for affixing the CE marking and for correct marketing within the European Economic Area. Thus, the manufacturer can perform a conformity assessment e.g. for Class I devices without involvement of a notified body; for all other risk classes (also in the case of Class I devices that require sterilisation or include a measuring function) it is mandatory to involve a notified body.
The BfArM is not involved in conformity assessment or marketing of medical devices. Further information on this subject can be found e.g. under:
If a stand alone software or app is placed on the market as a medical device it is subject to the same regulations as all other medical devices. One example for such regulations are the incident reporting obligations of professional users and manufacturers or authorised representatives pursuant to Section 3 of the Medical Device Safety Plan Ordinance (Medizinprodukte-Sicherheitsplanverordnung, MPSV):
Decision supporting software
In general, software is usually considered a medical device when it is used for healthcare, if e.g. medical knowledge databases and algorithms are combined with patient-specific data and the software is intended to give healthcare professionals recommendations on diagnosis, prognosis, monitoring or treatment of an individual patient.
Software systems
If a software consists of several modules it is the manufacturer's responsibility whether he wants the modules as a whole to be qualified and classified or each module individually. If the entire system is qualified and if it consists both of software with and without the properties of a medical device, the system is subject to medical device legislation.
Telemedical software
In telemedicine the physician observes and assesses the patients' medical data using telecommunication technologies - e.g. via the internet. Patient and physician can be at different locations.
Depending on the intended purpose, communication systems for telemedicine can either be non-medical devices (purely for transfer of data) or a combination of non-medical devices and medical devices (e.g. in order to support diagnoses).
Hospital information systems (HIS)
Hospital information systems that support patient management are generally not medical devices, especially if they have the following intended purpose:
collection of data for patient admission
administration of general patient data
scheduling of appointments
insurance and billing functions
However, hospital information systems can be combined with other modules that could be medical devices.
Picture Archiving and Communication System (PACS)
For example, if the manufacturer of the PACS software specifies in the intended purpose that the software is only meant for storage or archiving of pictures and not for diagnosing, this would indicate that it is not a medical device. However, if the manufacturer intends the PACS software for controlling a medical device or to have an influence on its use or to allow a direct diagnosis, this would support its classification as a medical device.
Stand alone software or apps that are not medical devices
Operating system software:
Operating system software (e.g. Windows, Linux) is neither a medical device nor is it an accessory to a medical device.
Software for general purposes
Software for general purposes is not a medical device even if it is used in connection with healthcare.
Software or apps as health or fitness products
When differentiating medical devices e.g. from health or fitness products, the decisive issue is whether they are intended for medical or non-medical purposes. This is defined by the manufacturer of the product. Software or apps merely intended for sporting activities, fitness, well-being or nutritional aims without a medical purpose claimed by the manufacturer are generally not medical devices.
This guideline on the qualification and classification of stand alone software was drafted by the European Commission after consultation of the competent authorities, commission services, industry and notified bodies. The BfArM also implements this guideline in its decisions according to Section 13 MPG.
Pursuant to this guideline, a stand alone software must fulfil the following criteria in order to be classified as a medical device:
it has to be a computer program
the software has to have a different purpose than mere storage, archival, lossless compression, communication or simple search
the software has to be for the benefit of individual patients
the software has to have an intended purpose listed in Article 1(2)a) of Directive 93/42/EEC.
(In Germany, Article 1(2)a) of Directive 93/42/EEC has been implemented as national law in Section 3 number 1 MPG.)
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