Approval of Blood Pressure Monitors

Wie werden Blutdruckmessgerõte zugelassen?

In Germany, blood pressure monitors are approved by the Federal Institute for Drugs and Medical Devices (BfArM). Approval is based on tests and evaluations to make sure the device meets the relevant national and European regulations and standards.

Manufacturers must perform a risk assessment and go through a conformity assessment procedure to obtain the CE mark. The conformity assessment includes reviewing the technical documentation, testing by a notified body, and ongoing monitoring of the product after it is placed on the market.

Tests

The tests include, among other things, the following areas:

Technical tests: These check the devices technical characteristics, including measurement accuracy.
Clinical tests: The devices clinical performance is evaluated. This includes, for example, measuring blood pressure values in a large number of patients.
Biocompatibility tests: These check whether the device is biologically compatible, especially regarding skin contact.
Electromagnetic compatibility tests: These examine whether the device is affected by electromagnetic interference or generates such interference itself.

Both the technical and clinical tests focus on measurement accuracy. We explain the difference in the article "How accurate are blood pressure monitors?".

Approval process

The approval process for a blood pressure monitor in Germany includes several steps:

Submission of the application: The manufacturer submits an application for approval to the Federal Institute for Drugs and Medical Devices (BfArM).
Technical documentation: The manufacturer provides the BfArM with technical documentation describing how the blood pressure monitor works, its technical specifications, and its safety features.
Clinical data: The manufacturer also submits clinical data demonstrating the accuracy and reliability of the blood pressure monitor. These data can come from clinical studies or other sources, such as publications in scientific journals.
Review of the documentation: The BfArM reviews the technical documentation and clinical data and decides whether the blood pressure monitor meets the required standards.
Testing of the device: The BfArM may also carry out tests on the blood pressure monitor itself to ensure it meets the requirements.
Approval decision: If the BfArM determines that the blood pressure monitor meets the requirements, it grants approval and the device receives a CE mark.
Monitoring: The BfArM monitors the safety and performance of the blood pressure monitor after approval and can take action if necessary to protect patients.

Laws and regulations

A number of regulations and laws must be followed when approving a blood pressure monitor in Germany.

The Medical Devices Act (MPG) regulates the placing of medical devices on the market in Germany and provides the legal basis for the approval and supervision of blood pressure monitors.
The Medical Devices Operator Ordinance (MPBetreibV) sets requirements for the operation of medical devices and covers, among other things, the regular inspection and maintenance of blood pressure monitors.
The Medical Devices Safety Plan Ordinance (MPSV) requires manufacturers and operators of medical devices to create a safety plan and keep it up to date.
The Medical Devices Distribution Ordinance (MPAV) regulates the distribution of medical devices to end users and sets requirements for labeling and instructions for use.
The EU Medical Device Regulation (MDR) has been in force since May 2021 and governs the approval and supervision of medical devices in the EU.
The Directive on Active Implantable Medical Devices (AIMDD) applies to implantable medical devices, for example devices that are placed inside the body. It sets requirements for the design, manufacture and testing of such products.
Data protection laws: Blood pressure monitors can collect and store personal data. Manufacturers must therefore ensure they comply with data protection laws and guarantee data security.

Standards

Some of the applicable standards:

DIN EN ISO 81060-1
Non-invasive blood pressure monitors - Part 1: Requirements and test methods for non-automated devices (ISO 81060-1:2007); German version EN ISO 81060-1:2012
DIN EN ISO 81060-2
Non-invasive blood pressure monitors - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018 + Amd 1:2020); German version EN ISO 81060-2:2019 + A1:2020
DIN EN ISO 81060-3
Non-invasive blood pressure monitors - Part 3: Clinical investigation of continuous automated measurement type (ISO/DIS 81060-3:2021); German and English version prEN ISO 81060-3:2021
ISO 81060-1
Non-invasive blood pressure monitors - Part 1: Requirements and tests for non-automated type devices

Overall, manufacturers of blood pressure monitors must ensure their products comply with national and European regulations and standards to obtain approval in Germany.

Do blood pressure monitors need regular inspections and official calibration?

There are no rules for private devices. Pharmacies and medical practices must have devices checked every two years. This is also recommended for private use. Some pharmacies offer this as a service.

An official calibration (verification) is not necessary; the devices are only checked for measurement performance.

This article comes from BloodPressureDB – the leading app since 2011 that helps hundreds of thousands monitor their blood pressure every day. Our content is based on carefully researched, evidence-based data and is continuously updated (as of 11/2025).

Author Horst Klier has been intensively involved with high blood pressure since 2002 initially from personal experience and, since 2009, as the developer of BloodPressureDB. Thanks to his app and specialist platform used by millions as well as numerous publications, he is now regarded as a recognised blood pressure expert. As the author of several health guides and professional articles, he makes complex information understandable and practical.

We hope you found the article helpful. Accurate measurements are essential for good blood pressure control. Our app BloodPressureDB can help with that. Clear instructions walk you through taking measurements according to current guidelines. The app can also remind you if you wish. These features are fully available in the free version as well. Get the free app now.