Health insurance funds reimburse insured people for disability aids, and because disability aids are often also medical devices, this opens up a potential additional source of revenue for some medical device manufacturers.
This article explains which medical device manufacturers can benefit from this “reimbursement” of disability aids and the 5 steps these manufacturers should follow to achieve this.
Section 33 SGB V (German) grants people with statutory health insurance the right to the provision of disability aids. This is a benefit-in-kind.
As a result, a lot of manufacturers are keen to have their device “accepted” as a disability aid by the health insurance funds. To be accepted, the device must meet the definition of a “disability aid”, fulfill the specified objectives of disability aids and meet other criteria.
“Disability aids are items whose use replaces, facilitates, supplements or makes possible an impaired bodily function.”
Disability aids should contribute towards:
There may also be a right to disability aids in the context of preventative healthcare services – for example, to prevent the need for nursing care (Section 11 SGB V, Section 23 SGB V). In addition, disability aids should not be confused with care aids that make the provision of nursing care easier as defined by Section 40 SGB XI.
Examples of disability aids include:
Products for administering medicinal products into the human body, e.g., syringes, inhalation devices and application aids
A comprehensive list of disability aids can be found in the disability aids directory. (German)
The medical device and disability aids classes overlap.
A lot of medical devices are not disability aids. These include, in particular, products that are (only) intended for use by healthcare professionals. Examples would be X-ray machines, surgical drapes, clinical information systems (German) and laboratory equipment.
The definition of the term medical device overlaps with the definition of disability aid. Products that treat or alleviate illness, disability or injury are, by definition, medical devices.
Therefore, wheelchairs, blood pressure monitors, prostheses and aspirators are examples of disability aids that are also medical devices.
There are products such as toilet seats that do not have an intended purpose (as defined by the manufacturer) that would justify classifying the product as a medical device, but which may still count as a disability aid.
Guide dogs for the blind are also disability aids, but not medical devices.
Medical device manufacturers who want to find out whether their product is a disability aid as well as a medical device should check whether it meets the following criteria: The product:
Even if the product is not included in the disability aids directory, the product may still be a disability aid, as the disability aids directory is not exhaustive.
To have your medical device included in the disability aids directory published by the Spitzensverbands der gesetzlichen Krankenkassen (GKV-SV) (German), you have to submit an application. In order to find the correct application form, you will need the first seven digits of your future product number for your planned disability aid, the item number.
You will also need this number to identify the specific quality requirements for the product in the disability aid catalog.
The item number is obtained by working out the:
Use the GKV disability aids directory to work out the disability aid number. It provides you with useful details and a description of the product types if you click on the icons shown below.
The details page contains information such as:
Clicking on “Product types” shows a list of all product types broken down by site of application and subgroup.
For example, the product group “electrostimulation devices” contains, among other things, the site of application “nerves/muscles” and below that, among other things, a subgroup “low-frequency electrostimulation devices for pain treatment”.
This subgroup contains two product types, single-channel and multi-channel biphasic pain therapy devices with therapy memory.
Section 139 SGB V (German) describes the requirements to be met by a product before it can be included in the disability aids directory. In particular, the manufacturer must provide evidence of:
The disability aids directory defines the indication-related or use-related quality requirements (GKV-SV specific wording). These can be found in the respective product subgroups in the disability aids directory.
The specific quality requirements relate to, for example:
Make sure that you also give the information on these quality aspects in your product’s instructions for use.
In the case of medical devices, functionality and safety are considered to have already been demonstrated for the CE marking, even if additional testing may be required in borderline cases.
If non-conformities become apparent during these tests, manufacturers must expect that the umbrella organization will inform the authorities or the notified bodies.
Section 139 (5) SGB V does not explicitly state that, for medical devices, the clinical evaluation is enough to demonstrate the medical benefit. But, in practice, the requirements for the clinical evaluation and demonstrating the benefit of a medical device are higher (see, for example, MDR Article 61, MEDDEV 2.7/1 rev. 4) than the requirements for disability aids.
With regard to “clinical investigations”, (German) manufacturers often limit themselves to observational studies and investigations with lower evidence levels.
The requirements of the MDR and the SGB V are largely the same:
Examples of GKV requirements
MDR requirements in Annex I, Chapter III
Instructions for use
The intended purpose of the device/indication
Permissible operating conditions/locations of use
Existing risks of use and contraindications
Cleaning instructions/disinfection instructions
23.4(h, e) *
Instructions for reuse and the processes required for reuse
Assembly and installation instructions
Information on the material used
Table 1: Mapping the requirements for disability aids to the requirements of the MDR.
*: To be listed as performance characteristics or specifications for proper use
**: Limited to certain product groups
Conclusion: Use your instructions for use according to Annex I, Chapter III, Article 23(4) of the MDR as the basis for completing the application for listing as a disability aid and save yourself the work of having to write a new document.
The following table shows you which documents in your medical device technical documentation and/or clinical evaluation contain the required information:
Evidence required for the application for listing as a disability aid
Primary source in the technical documentation
Link to the clinical evaluation
Declaration of conformity
Where applicable, reports on verification tests/product test reports
The clinical evaluation references test results. The results are incorporated into the safety and performance evaluation.
Declaration of conformity
Where applicable, risk management
The clinical evaluation references the risk analysis and identified hazards. It also details other potential hazards and harm as well as their level of severity and probability of occurrence.
Compliance with quality requirements**
Device description, brochures, test report, etc.
The clinical evaluation references all the functional and technical product specifications from the product description, brochures, etc. and evaluates them.
E.g., observational studies according to the GKV-SV requirements
The clinical evaluation proves the clinical benefit and references all the clinical data (e.g., observational studies) on the product.
Information for proper and safe use in German
Instructions for use
The clinical evaluation references the instructions for use. It checks whether all warnings and safety instructions have been included in the instructions for use.
Table 2: Comparison of the information required for the application and information contained in the technical documentation.
* Functionality and safety are generally considered to have been demonstrated with the declaration of conformity. For novel products, additional documents may be required.
** The quality requirements differ within product groups and product subgroups.
Manufacturers often submit documents with their application for listing as a disability aid that neither meet the requirements of the applicable standards for medical devices nor the legal requirements.
This applies, in particular, to manufacturers of class I devices, who have problems demonstrating in their technical documentation that their device complies with the general safety and performance requirements.
Interface between instructions for use and risk management
Incomplete listing of product information and warnings for safe use.
This usually relates to the quality requirements for the product and the information in the instructions for use. (Read more after this table).
Check that the GKV’s requirements for the instructions for use have been met. MDR-compliant instructions for use largely meets these requirements – but the legal context of performance (GKV tasks) also has to be taken into account.
Read what should be included in the instructions for use and how they should be structured in our article on instructions for use (German)
Frequently pre-written, unsubstantiated expert opinions from the manufacturer instead of observational studies correctly conducted by independent institutions.
Use product-specific data that demonstrate the clinical benefit and relate to use within the indications.
Make sure they meet the GKV-SV requirements.
Incomplete product knowledge, lack of product data
If you are an authorized distributor and are registering a disability aid: request access to the disability aid's technical documentation from the manufacturer.
Lack of clarity regarding
• The location of use
• The user group
and the associated reimbursement process
Specify all possible locations of use (free market, clinic, hospital, care home, domestic environment, residential environment, etc.) of your product and identify the possible reimbursement processes for your product based on this.
Table 3: The most common deficiencies in disability aid application documents
You should now have all the documents needed to be able to submit your application.
The GKV-SV lists over 118 different application forms that you can download here. Choose the right form for your product based on the seven-digit item number you worked out in a previous step.
You already know what you have to demonstrate:
Submit at least the following documents to the GKV-Spitzenverband:
The MDR already requires these documents and this information in Annexes I and II.
An incomplete application for disability aid listing delays the inclusion of your medical device in the disability aids directory.
It's not just for you that the documents to be submitted are extensive. The people reviewing your application also need to stay on top of things.
Check our article on the technical documentation to make sure that your technical documentation complies with the requirements of the MDR and, as a result, helps you complete the application for the listing of your disability aid.
Help yourself and the GKV-SV check that your application is complete. To do this, create a table that lists all the quality requirements that apply to your product.
Justify the selection of the quality requirement and enter the references to the supporting documents including the page number.
Only submit relevant excerpts from the technical documentation. The reviewer does not need the complete technical documentation. In addition, some documents may be subject to company-specific confidentiality regulations.
Proving functionality, safety and benefit should not be too much of a challenge for medical device manufacturers because the corresponding requirements in the MDR are more detailed and stricter.
Nevertheless, manufacturers should not rely on reviewers waving through their product just because it is a medical device with CE marking.
In the case of class I devices in particular, it often doesn’t become apparent until the application has been submitted that the manufacturer has not sufficiently demonstrated compliance with the general safety and performance requirements or that the technical documentation does not meet the requirements of Annex II of the MDR.
The Sozialgesetzbuch and case law govern which products the health insurance funds have to make available to the people they insure. And because the health insurance funds are under cost pressures, they will reject incomplete and incorrect applications.
The advice in this article will help you get your product added to the disability aids directory.
A lot of manufacturers are disappointed with the prices that insurance funds are willing to reimburse. As a result, they are dependent on their products being prescribed at a sufficiently high rate.
It is the manufacturer's job to make sure that the products are actually prescribed. Here too, they have to hold their own against the competition, for example through their unique selling points.
If products are no longer being prescribed often enough, manufacturers could also face the threat of their devices being removed from the disability aids directory.
Medical device manufacturers should look at whether they can (also) market their medical devices as disability aids. This review should include a review of the legal requirements and the economic viability of the project.
Find out more in podcast episode 2021-06 on disability aids. (German)
Precise technical documentation is an indispensable precondition for marketing both medical devices and disability aids.
Do you still have questions about your technical documentation documents? The Johner Institute will be happy to help you check they are complete. Contact us, for example using the web form, if you would like to know more.
If you have any questions on inclusion in the disability aids directory, Dipl.-Ing. Norbert Kamps, who is an expert in disability aid provision, will be happy to help you.