One Rule Away from Compliance – Navigate MDR Classification with Experts.
MDR Classification of Medical Devices: A Complete EU Guide
Under the EU MDR 2017/745 regulation, correctly classifying your medical device is the first and most critical step toward CE Marking compliance. Classification determines the level of regulatory scrutiny, the involvement of a Notified Body, and the documentation required for market access. Whether your device falls under Class I, IIa, IIb, or III, understanding the rules of Annex VIII is essential for compliance and avoiding costly delays.
At RegHelps, we guide you through accurate MDR classification based on intended use, mode of action, and associated risk ensuring a strong foundation for CE Marking success.
EU MDR Device Risk Classes
Under EU MDR 2017/745, medical devices are classified into four main risk categories: Class I, Is, Ir, Im, IIa, IIb, and III. Classification is based on factors like invasiveness, duration of contact, and the part of the body affected. Devices with higher potential risks require greater regulatory oversight and Notified Body involvement. Understanding the distinction between these classes is critical for preparing the right technical documentation and compliance pathway.
How Classification Is Determined (Annex VIII Rules)
Common Classification Mistakes to Avoid
service related FAQ’s
All MDD-certified devices must transition to MDR compliance by the applicable deadline. Significant changes to the product or intended use may require a full MDR re-certification.
Some key documents include the Technical Documentation (Annex II & III), Clinical Evaluation Report (CER), Risk Management File, PMS/PMCF Plans, and labeling/instructions for use (IFU) compliant with GSPR
The timeline varies based on device class and documentation readiness. Class I devices may take a few weeks, while Class IIa, IIb, and III devices requiring Notified Body review may take 6–12 months or more.
Yes. We help you identify the most suitable Notified Body based on your device type, risk class, and review timelines and support you throughout the submission and technical documentation review process.
All medical device manufacturers intending to sell devices in the EU, including Class I, IIa, IIb, and III must comply with the MDR.
