In the rapidly evolving European regulatory landscape, correct classification of medical devices and in vitro diagnostic medical devices (IVDs) under the Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746) is pivotal. Misclassification can lead to delays in market access, costly rework, compliance risks, and, most importantly, patient safety issues. Correct classification lays the foundation for the entire regulatory process, determining the applicable requirements, conformity assessment pathways, and the level of scrutiny by Notified Bodies.
Why is Correct Classification Critical?
The classification process categorises devices based on their intended purpose, inherent risks, and complexity. Under MDR and IVDR, devices are grouped into risk-based classes, ranging from low-risk Class I devices to high-risk Class III for medical devices, and from low-risk Class A to high-risk Class D for IVDs. A higher classification entails more rigorous requirements for conformity assessment, clinical evidence, post-market surveillance, and ongoing regulatory obligations.
Misclassifying a device can have severe consequences. For example, a device incorrectly classified as a lower-risk category might evade necessary scrutiny, leading to potential patient safety hazards. On the other hand, unnecessarily over-classifying a product could result in excessive regulatory burdens, higher costs, and delays in bringing a product to market.
Importance of Classification on Conformity Assessments
Conformity assessment is the process that ensures a device meets all applicable regulatory standards before it is marketed. This process varies depending on the classification and for higher-risk devices, independent assessment by a Notified Body is mandatory. Correct classification guarantees that the appropriate level of conformity assessment is applied, safeguarding compliance while avoiding unnecessary or insufficient regulatory procedures.
How Can we Help?
Given the complexity and nuances of classification under MDR and IVDR, navigating these regulations demands expertise and precision. Our consultancy team can help you with the appropriate classification of your device, helping you avoid unwanted setbacks in the future. Making use of our service also guarantees that your device is on the correct path for conformity assessment, mitigating the risk of compliance issues or market access delays.
Reach out today to learn how our classification rationale service can streamline your path to MDR/IVDR compliance.
