Classification of medical devices - how does it work?

Determining the legal status and classification of medical devices is crucial for manufacturers to ensure the safety of patients and users and to strictly comply with the regulatory requirements of the Medical Device Regulation (MDR).

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Why is the classification of a medical device important?

The classification determines to which risk level the device is assigned — from class I (low risk) to class III (high risk) — and thus influences the scope of the required conformity assessment procedures, the technical documentation, whether a notified body is to be involved in the conformity assessment process, the clinical evaluation and post-marketing monitoring. But above all, the type and extent to which a clinical study or clinical trial must take place. Higher classes mean a more complex process with stricter safety and clinical evaluation requirements. The CE mark finally documents successful compliance with all applicable regulatory requirements and entitles the right to legally compliant marketing in Europe.

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What are the legal requirements for the classification and legal status of the medical device?

The determination of the legal status of a device is based on the definition of medical devices in Article 2 No. 1 of Regulation (EU) 2017/745 (Medical Device Regulation, MDR) or the definition of in vitro diagnostics in accordance with Article 2 No. 2 of Regulation (EU) 2017/746 (In Vitro Diagnostic Device Regulation, IVDR). Classification is carried out in accordance with the classification rules of Annex VIII of MDR and Annex VIII of IVDR. Other sources, such as the MDCG documents from the European Commission, can be used for decision-making.

Support is provided in the guidance documents (MDCG 2021-24) from the Medical Device Coordination Group (Medical Devices Coordination Group, MDCG). Since there are currently (as of 2025) changes in interpretation in some areas, the content is not listed here, but links to their website here: https://health .ec.europa.eu/med ical-devices-sec tor/new-regulations/guidance-mdcg-endorsed-documents-and-other-gui dance_en (delete space for link).

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How is the classification of a medical device determined?

The classification of a medical device is determined by the manufacturer in accordance with the classification rules in Annex VIII of EU Regulation 2017/745 (MDR). The classification is based on the intended purpose of the product and on risk criteria such as:

• duration of use (temporary, short-term, long-term),
• degree of invasiveness (non-invasive, surgically invasive, implantable),
• use on the central circulatory system or central nervous system,
• reusability as a surgical instrument,
• active function (therapeutic or diagnostic),
• use of biological material from humans or animals.

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Who ultimately decides on the legal status or classification of a medical device?

For a decision to determine the legal status or to classify or classify a product, an informal application must be submitted to the Federal Institute for Drugs and Medical Devices (BfArM), in accordance with Section 6 paragraph 1 or paragraph 2 number 1-3 of the Medical Device Law Implementation Act (MPDG).

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How do you obtain the classification of the medical device as a manufacturer, its EU representative, notified body or German state authority?

For a decision to determine the legal status or to classify or classify a product, an informal application must be submitted to the Federal Institute for Drugs and Medical Devices (BfArM), in accordance with Section 6 paragraph 1 or paragraph 2 number 1-3 of the Medical Device Law Implementation Act (MPDG). Manufacturers, their EU representatives, notified bodies or competent state authorities based in Germany are eligible to apply.

The decision is always based on a single, clearly defined product and its individual purpose, as well as usage information, labelling and, if applicable, advertising material. Decisions cannot be made for entire product groups.

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What information must such an application contain?

The application must be accompanied by extensive documentation, including:

• trade name of the product including version number (for software),
• exact manufacturer information,
• technical documentation including purpose, classification, instructions for use, labelling and packaging,
• assessment of the applicant to classify and determine the legal status,
• any existing correspondence with authorities or notified bodies,
• product composition, mechanism of action, literature, samples and promotional materials,
• signature of the applicant and, if applicable, power of attorney in the case of an application by a third party, and
• If necessary, further information.

The determination is based on the definitions and classification rules of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). After the application has been submitted, the manufacturer is given the opportunity to comment.

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Where do I apply for classification of my medical device?

The application must be submitted by email to mp-klar (a) bfarm.de with an assessment of the reasons for your own classification or determination of the legal status of the medical device.

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This is important for manufacturers in order to clearly fulfill regulatory obligations, obtain approvals and minimize liability risks. Authorities such as the BfArM are contacts and decision makers in case of uncertainties regarding the classification or legal status of products.

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And how is my “medical app” classified?

Software applications for mobile phones and tablets, so-called “apps”, are now everyday companions at work and leisure. The supply in the so-called “health sector” has also increased rapidly in recent years. Apps measure physical fitness and sleep, provide tips on healthy behavior or illness, analyze body-related data and calculate the dose of medication or make recommendations.

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It is often not easy for developers and manufacturers to recognize whether a product as a medical device (then also standalone software, standalone software) falls under Regulation (EU) 2017/745 (MDR) and the corresponding other regulations? The limits sometimes appear blurred and must be adhered to very precisely. In Germany, the Federal Ministry of Drugs and Medical Devices (BfArM) provides support for differentiating apps between medical and other products and for subsequent risk classification. On their website, there is guidance which is intended to support considerations prior to submitting an application to the BfArM in accordance with Section 6 (2) MPDG.

However, the decision regarding the delimitation and classification, which is to be made on the basis of the specific purpose of the software, and the corresponding marketing, remains the responsibility of the manufacturer, possibly in consultation with a notified body.
The manufacturer of the software, the state authority responsible for this manufacturer and any notified body involved in the conformity assessment process are eligible to apply.

You can find out more about DiGA (digital health applications) here or here, on the differences with “health apps” here and on the decentralized digitized clinical studies that may be suitable for this here.

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And why is an independent scientific institution (or even as a contract research organization, clinical research organisation, CRO) such as MEDIACC working on the topic?

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As our client, we will provide you with a safe and efficient path to market approval, reimbursement and clinical use. The exact classification in accordance with the European Medical Devices Regulation (MDR) determines which clinical trials, evidence and regulatory steps are required. These requirements are complex, change regularly and compliance with all requirements also ensures the protection of our patients, both those from the clinical trial and later those in everyday clinical practice. And for you, as a manufacturer, a product that you can be proud of.

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Do you need an assessment or initial advice on the classification of your medical device or are you wondering whether you need a clinical trial or clinical trial? Contact us for an initial consultation!