Placing medical devices on the market 

The purpose of the medical software is the most important factor in determining whether it is medical software or not. Our team will carry out the assessment together with you.

Software is considered medical if it is used independently or in combination for a medical purpose under the MDR or IVDR, whether it is standalone software or influences the function of a medical device.

Each piece of medical software is assigned to a risk class, which is based on the potential damage that a fault or functional failure of the medical device can cause. The risk classes range from class I (low risk) to IIa and IIb to class III (high risk). Key distinctions include:

• Software that provides information for diagnostic or therapeutic purposes is typically classified as Class IIa.
• If the software’s failure could result in death or irreversible harm, it is classified as Class III.
• Software intended to control physiological processes is Class IIa, unless it controls vital physiological parameters, in which case it is Class IIb.

Software intended for the control of physiological processes belongs to class IIa unless it is intended for the control of vital physiological parameters. In this case, it is assigned to class IIb.

All other medical software is classified as class I.

We support manufacturers in determining the applicable regulations that are relevant for their medical devices, i.e. their medical software or medical apps. In this way, manufacturers ensure that they comply with all relevant regulations.

Applicable regulations for medical devices include, for example, the Medical Devices Implementation Act (MPDG), Medical Device Regulation (MDR), MEDDEV documents (or future MDCG guidelines under the MDR) or ISO 13485.

The technical documentation includes at least all documents that manufacturers of medical devices must provide in accordance with the Medical Device Regulation (MDR).

This documentation is critical to proving that the medical software or app meets essential requirements and is required for the conformity assessment. Learn more in our “Technical Documentation” section.

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To be allowed to place medical devices on the European market, a CE mark must be affixed to the product. The prerequisite for obtaining the marking is the implementation of a conformity assessment procedure.

There are three conformity assessment procedures:

• Conformity assessment based on a quality management system and an assessment of the technical documentation. The manufacturer creates a quality management system in accordance with the requirements of the MDR.
• Conformity assessment based on a type examination: A so-called type examination is an EU procedure in which a notified body determines that a product, including its technical documentation and the relevant processes during the product life cycle, fulfils the requirements of the MDR.
• Conformity assessment based on a product conformity assessment. This assessment procedure is intended to ensure that devices for which an EU type examination certificate already exists comply with their type and the requirements of the MDR. This can be done in two ways: Either following the production quality assurance procedure or the product verification procedure.

Selection of the conformity assessment procedure:

The conformity assessment procedure to be followed depends on the risk class of the medical device. The classification rules of the Medical Device Regulation generally assign medical software to Class IIa or higher.

Manufacturers of Class II or III medical devices must have their conformity assessed by a notified body.

• Manufacturers of class IIa and IIb medical software must carry out the procedure relating to the quality management system and an assessment of the technical documentation. For Class IIa products, technical documentation can alternatively be prepared in combination with a product conformity assessment.
• For manufacturers of Class III medical software, the procedure applies based on a quality management system and an assessment of the technical documentation. Alternatively, the procedure for the type examination can be carried out in combination with the procedure for the product conformity test.

Our quality management team will be happy to advise you on organising the registration of medical software with the BfArM (Federal Institute for Drugs and Medical Devices).

According to the Medical Devices Act, manufacturers based in Germany who place medical software on the market for the first time must notify the BfArM of this before commencing their activities, stating their address.

Our team supports the entire CE marking process or specific parts of it. The CE mark indicates that the medical software complies with the essential requirements of relevant European regulations, such as the Medical Device Regulation EU 2017/745 (MDR).

Detailed information can be found in our "CE Labelling" section.

Learn more