As software is becoming increasingly important in healthcare, manufacturers face uncertainty with respect to regulatory requirements

MDR for Medical Device Software

Determining whether medical device software is safe and performant is complex. Under the new Medical Device Regulation (EU) 2017/745 (MDR), which entered into force on May 26th, 2017, the classification of medical device software often leads to higher risk categories compared with the former directive, which subsequently calls for the collection of additional evidence on the software device performance and safety.Especially for medical device software incorporating Artificial Intelligence, specific guidance on conformity assessment is currently lacking.

Clinical Evaluation of Software brings its challenges

MDR-compliant Clinical Evaluation

As for any other medical device, manufacturers of Medical Device Software should prepare a Clinical Evaluation file to address all relevant requirements of the MDR 2017/745 and guidance documents, including demonstration of the valid clinical association, and technical and clinical performance.

Sufficient Clinical Evidence

Demonstration of the clinical performance of Medical Device Software might be a challenging task, requiring the creation of a solid clinical development plan, justification of the sufficient level of evidence needed to demonstrate performance and safety, and appraisal of the clinical evidence with solid statistical justification. 

Validation of Machine Learning-based Medical Device Software

Evidence of validation of Machine Learning-based software should meet the general requirements of the MDR with respect to their adequacy, to fully demonstrate the device performance and safety in view of its intended use (e.g., dataset generalisability), as well as with respect to the methodology followed for data generation.

How Medidee Supports your MDR Transition Process

A successful Clinical Evaluation of Software requires all crucial steps to be considered and managed effectively. With our expertise, resources, and unique experience gathered from recent interactions with Notified Bodies, we are able to support you with:

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Preparing your Clinical Evaluation file against MDR Requirements and related guidelines

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Assisting with subsequent updates required through training, coaching, execution or any combination of those

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Assessing the adequacy of the clinical evidence available for your medical device software in view of the requirements of the MDR and the pertinent state of the art

Strategy, Innovation and Business combined

Manufacturers of Medical Device Software face increased complexity and tighter timelines in the current regulatory framework. It is important to know exactly what steps must be taken and how to manage all the requirements effectively.


Medidee’s unique approach looks at your submission strategically, with the aim of increasing the coherence and the dependability of all the dimensions considered, while keeping an innovative and business-oriented perspective.


By working proactively with us, you will ensure that your Clinical Evaluation integrates the latest requirements and expectations, for a well-managed transition to MDR. 

Strategy, Innovation and Business Combined

Contact Medidee to discuss your needs