Free Medical Device & IVD Regulatory Software Tools
Free medical device and IVD regulatory software tools to support product determination, classification, and compliance planning under MDR and IVDR.
Free Regulatory Software Tools for Medical Devices & IVDs
Patient Guard provides free medical device and IVD regulatory software tools designed to support manufacturers, start-ups, software developers, and regulatory professionals with preliminary regulatory assessments and compliance planning.
Our growing range of online tools helps users:
- Determine whether a product may qualify as a medical device or IVD
- Identify potential classification pathways
- Understand regulatory requirements under MDR and IVDR
- Support early-stage regulatory strategy decisions
The tools are designed to simplify complex regulatory frameworks and improve understanding of medical device and in vitro diagnostic regulatory requirements.
Patient Guards Medical Device and IVD Software Tools
Medical Device Determination Tool
Patient Guard has developed a free Medical Device Determination Tool to help manufacturers, start-ups, software developers, and regulatory professionals assess whether a product or concept may fall within the definition of a medical device under the EU Medical Device Regulation (MDR) 2017/745.
Our easy-to-use online tool guides users through a series of regulatory questions relating to the intended purpose, functionality, and claims associated with the product. Based on the responses provided, the tool helps identify whether the product may need to comply with EU MDR requirements before being placed on the European market.
Medical Device Classification Tool
Patient Guard has developed a free Medical Device Classification Tool to help manufacturers, start-ups, and regulatory professionals identify the likely classification of a medical device under the EU Medical Device Regulation (MDR) 2017/745.
Our easy-to-use online tool guides users through a structured series of questions based on the classification rules outlined within Annex VIII of the MDR. The tool supports preliminary classification assessments and helps manufacturers better understand the potential regulatory pathway and conformity assessment requirements for their device.
Software as a medical device (SaMD) determination tool
The regulatory landscape for digital health has shifted dramatically under the EU MDR, IVDR, and MHRA frameworks, leaving many developers unsure if their code crosses the line into a regulated medical device.
To provide immediate market clarity, Patient Guard has launched an interactive SaMD & MDSW Qualification Tool.
Built directly upon the formal logic of the European Commission’s MDCG 2019-11 and MDCG 2021-24 guidelines, this intuitive, step-by-step screening engine allows standalone software developers, mobile health app creators, and AI innovators to stress-test their product’s intended purpose against official criteria.
In less than two minutes, you can validate your regulatory status, identify your structural data boundaries, and establish an actionable compliance baseline before investing in a formal audit.
Medical Device Borderline Identification Tool
Navigating the shifting boundaries between the EU MDR, IVDR, and companion frameworks demands absolute scientific and regulatory precision.
To assist manufacturers and developers in accurately establishing their regulatory trajectories, we have launched an interactive, logic-driven qualification wizard. Grounded in the latest MDCG guidelines and the Helsinki Procedure consensus framework, this self-service tool steps you through a sequential analysis of your product’s intended purpose, primary mode of action, and data-processing profiles.
By evaluating these core attributes, the tool provides immediate clarity on whether your innovation qualifies as a standard medical device, Medical Device Software (MDSW), an accessory, or falls under separate biocide, PPE, cosmetic, or medicinal frameworks—allowing you to mitigate enforcement risks and map an audit-ready route to market from day one
In Vitro Diagnostic (IVD) Determination Tool
If you are developing a software platform, bioinformatics pipeline, or AI algorithm that interacts with human clinical data, navigating the boundary between general software and a regulated diagnostic is a critical first step.
Our interactive EU IVDR Article 2(2) Qualification Tool is designed to eliminate the guesswork. By answering a few targeted questions about your software’s intended use, data inputs, and medical claims, you can instantly determine if your product qualifies as an In Vitro Diagnostic Medical Device (IVD) under Regulation (EU) 2017/746.
Use this baseline assessment to confidently establish your European compliance strategy, mitigate the risks of misclassification, and map out your correct pathway toward Notified Body certification.
