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Insight into the world of medical device approval – What you should know as a consumer

Sep 30, 2025

Have you ever wondered how you, as a consumer, can apply to a doctor for a medical device you need? Medical device approval plays a crucial role in ensuring that the products you need meet the highest quality and safety standards. In this blog post, you'll learn how to apply to a doctor for a medical device and what steps you need to follow.

What are medical devices?

Basically, according to the definition of the Social Code Book V, aids are objects “which are necessary in individual cases to ensure the success of medical treatment, to prevent an impending disability or to compensate for a disability, insofar as they are not to be regarded as general everyday objects.” (Section 33 SGB V)

Medical aids are items that are necessary in individual cases to ensure the success of medical treatment.

How is a product approved as an aid?

The medical aid directory allows you as a consumer to see which products are officially approved as medical aids. The directory is divided into 39 product groups, which, depending on the aid, determine the first two digits of the aid number assigned to each product. Each product group (e.g. group 15 for incontinence aids) has specific quality standards and requirements that must be met for an aid to be included. The GKV-Spitzenverband decides whether a product is included in the medical aid directory after the Medical Service has carried out a medical-technical examination. Once a decision has been made and the product is officially classified as an medical aid, it is entered in the medical aid directory and receives a ten-digit aid number, which enables the doctor to prescribe the product for you as part of the statutory health insurance benefits.

How can a medical device be prescribed?

If your prescribing physician considers a specific medical device appropriate for your individual treatment, they can provide the ten-digit item number, the quantity, and a precise description of the device on a corresponding form. In addition, a diagnosis and, if applicable, information about the intended purpose, method of manufacture, material, and dimensions are required.

You will receive a prescription from your doctor for your prescribed aid, which you can redeem at a pharmacy, for example.

Step 1: Open conversation with your doctor
The first step is a frank discussion with your doctor. Explain your needs and why you need a specific device. Your doctor will assess your medical situation and determine whether a device is necessary.

Step 2: Recommendation and recipe
If your doctor believes you need a medical device, they will recommend it and issue a prescription. This prescription should include all the important details about the device you need.

Step 3: Selecting the aid
Your doctor will likely also recommend specific assistive devices. It's important to consider this advice and choose the device that best suits your needs.

Step 4: Approval and authorization
Once you've selected the device, your doctor will take the necessary steps to obtain approval and authorization for the device. This may include submitting documentation to the relevant regulatory authorities or health insurance companies.

Step 5: Collection or delivery of the aid
Once approved, you can pick up the device from a pharmacy or specialized medical supply store. In some cases, the device will also be delivered directly to your home.

Step 6: Instruction and use
It's important that you receive thorough instruction on the correct use and care of the aid. This can be done either upon pickup or upon delivery. Make sure you understand all instructions and have all your questions answered. Your satisfaction and safety when using the aid are our top priority.

ELANEE products as prescription aids:

You can obtain a prescription for the following ELANEE products as aids. Talk to your doctor about whether the aid is suitable for you. These products can be made available to you through a doctor's prescription under statutory health insurance. If you have any questions or need further information, please speak to your doctor. Your health is our top priority, and your doctor can help you receive the best possible care.

Pelvic floor training aids Phase I active:

To the product

Training with our ELANEE Phase I pelvic floor training aids actively promotes awareness of the pelvic floor and strengthens the pelvic floor muscles. Regular training can improve, resolve, or prevent bladder weakness (stress incontinence).

Prescription for stress incontinence.

Breast rings:

To the product

Our ELANEE breast rings protect sensitive, painful, sore and inflamed nipples from contact by keeping them in a hollow position.

Prescription required for gestational breast infection.

Support belt:

The ELANEE support belt is an orthopedic belt for relieving back or pelvic girdle pain in pregnant women and for stabilizing the abdominal wall after birth.

Prescription for lumbar back pain during pregnancy.

Always seek medical advice

Important note: This article contains only general information and should not be used for self-diagnosis or treatment. It is not a substitute for a consultation with a doctor.

FAQ on vaginal dryness

What creams help with vaginal dryness?

For dry and irritated skin in the intimate area, a suitable intimate care cream is the perfect choice. Our ELANEE Intimate Care Cream moisturizes the external intimate area thanks to valuable oils and regenerating panthenol, protecting it from natural influences such as moisture.

What to do if vaginal dryness occurs during menopause?

If vaginal dryness occurs during menopause, it is advisable to consult a doctor to determine the cause. Treatment may include hormone preparations, vaginal suppositories for lubrication , or moisturizing creams .

What to do if vaginal dryness occurs during intercourse?

In order to enjoy sexual intercourse despite a dry vagina, there are various creams or lubricants that prevent painful friction.

What helps with vaginal dryness and itching?

Moisturizing creams can moisturize the external intimate area. Their ingredients soothe irritated skin and relieve itching. Moisturizing suppositories are available to nourish the mucous membranes and aid regeneration.

What can you do about vaginal dryness before your period?

If you experience vaginal dryness before your period, there can be various reasons. Hormonal fluctuations, for example, or external factors such as stress, inadequate intimate hygiene, or menstrual products could be the cause. Use an intimate care cream to care for dry skin in the external intimate area. Before your period starts, you can also use vaginal suppositories to moisturize the vaginal mucosa. If vaginal dryness persists during your period, we recommend using menstrual cups . Unlike tampons, they don't need to be replaced as quickly and don't remove additional moisture from the vagina.

What can you do about vaginal dryness after childbirth?

Vaginal dryness after childbirth is a normal side effect caused by hormonal changes. A drop in estrogen levels is particularly responsible for this. To alleviate the symptoms, appropriate intimate care products or home remedies can be used. In severe cases, estrogen supplements can also help regulate hormone levels. We recommend consulting your midwife or doctor.

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