Approval of blood pressure monitors

How do blood pressure monitors obtain CE marking?

Blood pressure monitors are medical devices. In everyday language, their market access is often referred to as „approval“. However, under the standard European procedure, there is no regulatory approval by the Federal Institute for Drugs and Medical Devices (BfArM), as is required for medicines, for example.

Before placing the device on the market, the manufacturer must demonstrate that it meets the requirements of the EU Medical Device Regulation (MDR). This is done through a conformity assessment procedure. Once this procedure has been successfully completed, the manufacturer draws up the EU declaration of conformity and affixes the CE marking to the product.

Conformity assessment and CE marking

The manufacturer is responsible for the safety, performance, and conformity of its product. The standard process includes in particular:

Intended purpose and classification: The manufacturer specifies what the device is intended for and determines its risk class based on the MDR. Standard electronic blood pressure monitors for routine or self-measurement are generally assigned to Class IIa. A different classification may apply depending on the design and intended purpose.
Evidence and documentation: Among other things, the manufacturer prepares the technical documentation, carries out risk management and the clinical evaluation, and establishes a quality management system appropriate to the product's risk class and type.
Involvement of a Notified Body: Where required by the risk class or measuring function, an independent Notified Body assesses the documents and processes stipulated in the relevant procedure. If the assessment is successful, it issues the required certificate.
EU declaration of conformity and CE marking: The manufacturer declares conformity and affixes the CE marking. If a Notified Body was involved, its four-digit identification number appears next to the CE mark.
Post-market surveillance: The manufacturer must continue to monitor the device's safety and performance, evaluate findings, and initiate required reports or corrective actions.

What is assessed?

The evidence required depends on the device's design and intended purpose. This may include in particular:

Technical testing: for example, of the pressure measurement system, the cuff, and electrical and mechanical safety,
electromagnetic compatibility: protection against interference and limitation of the device's own electromagnetic emissions,
biocompatibility: where materials come into contact with the skin during their intended use,
usability, software, and IT security: where these aspects are relevant to the specific device,
clinical evaluation: the systematic evaluation of clinical data on safety and performance.

Clinical validation of measurement accuracy

The clinical validation of measurement accuracy must be distinguished from the comprehensive clinical evaluation under the MDR. In such a validation study, the readings from a specific blood pressure monitor are compared with a reference method under defined conditions. Among other things, the test protocol specifies the selection of test subjects, the comparative measurements and the permitted deviations.

For example, DIN EN ISO 81060-2 describes a corresponding procedure for automatic cuff devices that measure intermittently. Successful validation provides important evidence of measurement accuracy. However, it replaces neither the clinical evaluation nor the complete conformity assessment procedure.

Voluntary quality seals or recommendation lists must also be distinguished from CE marking. They may impose additional requirements for measurement accuracy, but are not part of the regulatory or European market access process.

What is the role of the BfArM?

The BfArM is not involved in the regular conformity assessment procedure and does not issue CE markings. Among other things, it performs key tasks in assessing risks and reported incidents. In Germany, market surveillance is generally the responsibility of the competent authorities of the federal states.

An official special authorization is intended only for justified exceptional cases. Under Article 59 of the MDR and Section 7 of the MPDG, the BfArM may permit a specific product to be placed on the market or put into service even though the regular conformity assessment procedure has not been carried out. One key requirement is that its use must be in the interests of public health or patient safety or health. Such a special authorization does not constitute the granting of a CE marking.

Current legal bases

The following are particularly relevant for blood pressure monitors:

EU Medical Device Regulation (MDR, Regulation (EU) 2017/745): requirements for medical devices, conformity assessment, clinical evaluation, CE marking, and post-market surveillance,
German Medical Device Law Implementation Act (MPDG): supplementary German regulations, responsibilities, and special authorizations,
German Medical Devices Operator Ordinance (MPBetreibV): requirements for the operation and use of medical devices,
German Medical Device User Reporting and Information Ordinance (MPAMIV): reporting of suspected serious incidents and exchange of information between authorities.

The former German Medical Devices Act (MPG), the German Medical Devices Safety Plan Ordinance (MPSV), and the former Directive on Active Implantable Medical Devices (AIMDD) are not key current legal bases for this standard procedure. However, statutory transitional provisions still apply to certain older products.

Standards for blood pressure monitors

Depending on the design and intended purpose, the following standards may be relevant, among others:

DIN EN ISO 81060-1:2012-08
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated types
DIN EN ISO 81060-2:2024-08
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated types
DIN EN ISO 81060-3:2023-06
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated types
DIN EN IEC 80601-2-30:2020-03
Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Standards describe technical requirements and test methods. Applying them or passing a test does not in itself constitute approval. Harmonised standards can make it easier to demonstrate compliance with the MDR requirements they cover; however, the conformity of the entire product must still be demonstrated using the prescribed procedure.

Do blood pressure monitors have to be regularly inspected and calibrated?

For a blood pressure monitor purchased and used solely for personal purposes under the user's own responsibility, the MPBetreibV does not require regular metrological checks. Nevertheless, the manufacturer's instructions must be followed.

Within the scope of the MPBetreibV, devices for non-invasive blood pressure measurement are generally subject to metrological checks. Annex 2 specifies a two-year reinspection period. This period begins at the end of the year in which the device was put into operation or last underwent a metrological check. The obligation applies to the operator and is not generally tied to specific professional groups such as pharmacies or medical practices.

For certain devices intended for use by laypersons and provided as part of care, the inspection is waived only under the conditions specified in Section 15(3) of the German Medical Devices Operator Ordinance (MPBetreibV). In particular, this requires a manufacturer's certificate confirming that the device remains within the maximum permissible measurement error throughout its entire service life.

A metrological check is not a legal verification. It determines whether the device remains within the maximum permissible limits of measurement error.

This article is from Tensana – the leading app since 2011, helping hundreds of thousands of people monitor their blood pressure every day. Our content is based on carefully researched, evidence-based data and is continuously updated (as of 08/2026).

Author Horst Klier has been closely involved with high blood pressure since 2002 – initially because he was personally affected and, since 2009, as the developer of Tensana – and is now regarded as a recognized blood pressure expert thanks to his app and specialist platform, used millions of times, as well as his numerous publications. As the author of several health guides and specialist articles, he communicates complex knowledge in a clear and practical way.

We hope you found the article helpful. Accurate measurements are essential for good blood pressure control. Our app Tensana 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.