Approval of Blood Pressure Monitors

How are blood pressure monitors approved?

Blood pressure monitors in Germany are approved by the Federal Institute for Drugs and Medical Devices (BfArM). The approval is based on tests and evaluations to ensure that the device meets the relevant national and European regulations and standards.

Manufacturers must conduct a risk assessment and undergo a conformity assessment procedure to obtain the CE marking. The conformity assessment procedure includes reviewing the technical documentation, testing by a notified body, and regular monitoring of the product after its market launch.

Tests

The tests include, among others, the following areas:

Technical tests: Here, the technical characteristics of the device are checked, including measurement accuracy.
Clinical tests: The device is evaluated for its clinical performance. This includes measuring blood pressure values in a large number of patients.
Biocompatibility tests: It is tested whether the device is biologically compatible, especially regarding skin contact.
Electromagnetic compatibility tests: This checks whether the device is affected by electromagnetic interference or generates it 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 the operation, technical data, and safety features of the blood pressure monitor.
Clinical data: The manufacturer also submits clinical data demonstrating the accuracy and reliability of the blood pressure monitor. This data may come from clinical studies or other sources, such as publications in scientific journals.
Review of documentation: The BfArM reviews the technical documentation and clinical data and decides whether the blood pressure monitor meets the required standards.
Device testing: The BfArM may also conduct a test of the blood pressure monitor itself to ensure it meets the requirements.
Approval decision: If the BfArM believes that the blood pressure monitor meets the requirements, it grants approval, and the device receives a CE marking.
Monitoring: The BfArM monitors the safety and performance of the blood pressure monitor after approval and may take action as needed to ensure patient safety.

Laws and Regulations

When approving a blood pressure monitor in Germany, a number of regulations and requirements must be adhered to.

The Medical Devices Act (MPG) regulates the trade in medical devices in Germany and establishes the legal basis for the approval and monitoring of blood pressure monitors.
The Medical Devices Operator Ordinance (MPBetreibV) sets the requirements for the operation of medical devices and regulates, 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 update it regularly.
The Medical Devices Distribution Ordinance (MPAV) regulates the distribution of medical devices to end consumers and sets requirements for labeling and instructions for use.
The EU Regulation on Medical Devices (MDR) has been in effect since May 2021 and regulates the approval and monitoring of medical devices in the EU.
The Directive on Active Implantable Medical Devices (AIMDD) applies to implantable medical devices, such as blood pressure monitors, that are introduced into the body. It sets requirements for the design, manufacture, and testing of such products.
Data protection laws: Blood pressure monitors may collect and store personal data. Therefore, manufacturers must ensure compliance with data protection laws and ensure 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 types (ISO 81060-1:2007); German version EN ISO 81060-1:2012
DIN EN ISO 81060-2
Non-invasive blood pressure monitors - Part 2: Clinical testing of intermittent automated types (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 testing of continuous automated types (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 blood pressure monitors of the non-automated type

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

Do blood pressure monitors need to be regularly tested and calibrated?

There are no requirements for private measuring 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.

Calibration is not necessary; the devices are only checked for measurement accuracy.

By Horst Klier. This article is medically reviewed. Last updated by Sabine Croci (01/2024).
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