Classification of medical device software – efficient and legally compliant

Through conformity assessment procedure in 4 weeks

No additional Stage I and Stage II audits

Fast and cost-effective placing on the market

The increasing requirements for the classification of software medical devices present companies with considerable regulatory challenges. Rule 11, Annex VIII, of Regulation (EU) 2017/745 (MDR) in particular means that software is often classified in higher risk classes than previously assumed.

A recent decision by the Higher Regional Court of Hamburg (3 W 30/23) illustrates this: A software medical device that provides information for diagnostic or therapeutic decisions must be certified as at least Class IIa – even if it only collects and forwards data.

More on the effects

The ruling appears to have had a precedent-setting effect on some of the competent authorities. According to reports, certain authorities are increasingly approaching manufacturers of software medical devices in risk class I in order to review their risk classification. The authorities that appear to be particularly affected are those that were previously known for their rather lax handling of the risk class.

Many manufacturers are concerned that they could face a comprehensive conformity assessment procedure. This applies in particular to DiGA manufacturers, as the majority of medical devices listed in the DiGA directory belong to risk class I.

Blog on the decision

Challenges in the classification of software medical devices

Rule 11 of the MDR
In contrast to the old legal situation, this classification rule automatically classifies most software medical devices in higher risk classes. This applies in particular to software that provides diagnostic information, even if it does not perform any independent data analysis.
Legal consequences of misjudgment
Incorrect risk classification prevents your product from being lawfully placed on the market. This was shown in a case from Hamburg, where an incorrectly classified app for skin diagnostics led to a court ban on distribution.
Obstacles to innovation
Regulatory requirements that are not taken into account in good time can not only cause legal problems, but also lead to considerable delays in market launch.
Conformity assessment procedure
In addition, manufacturers must undergo a very time-consuming and cost-intensive conformity assessment procedure. This particularly affects manufacturers who have not yet undergone Stage I and Stage II audits by a notified body.
The duration of such an audit – even if an exemplary but non-certified quality management system is in place – can take more than a year with costs in the six-figure range.

Your advantages with BAYOOCARE

Thanks to our extensive expertise and our MDR certificates for medical software (EMDN Code: V92), we can carry out a full conformity assessment procedure (KBV) with the notified body within just four weeks*.

In this way, we ensure that your medical device software is brought to market quickly and in compliance with the law – without compromising on safety and quality.

In addition, we do not have to carry out additional Stage I and Stage II audits and can therefore offer the KBV at a significantly lower price. You only pay the costs for the Technical Documentation Review by the Notified Body – we take care of the rest.

*Prerequisite: The technical documentation complies with the basic safety and performance requirements

Fewer risks, more opportunities: our offer

With BAYOOCARE as your partner, you minimize your risks and maximize your opportunities:

Speed

Our certifications and experience enable a smooth and timely certification process.

Regulatory expertise

We accompany you through all phases – from the intended purpose and risk classification to full compliance with the MDR requirements.

Reliability

Rely on our ISO 13485 and MDSAP-certified processes that meet the highest standards on the market.

Simply contact us: We classify your medical device software and bring it to market safely and efficiently as your partner for regulatory excellence.