EU MDR Product Classifier-MDR Classification Guidance

Example

Determining if a software intended for diabetes management is Class I or higher.

Scenario

A developer is unsure whether their diabetes management app, which monitors blood sugar levels and advises on insulin dosage, requires a higher classification than Class I. The EU MDR Product Classifier helps identify that software impacting treatment decisions directly could be classified at least as Class IIa, depending on its intended use and potential risks.

Example

Identifying if a product with both cosmetic and medical applications falls under the MDR.

Scenario

A company creates a skin cream designed for reducing scarring after surgery but also promotes it for cosmetic use to reduce aging signs. The classifier can help determine if the product's primary intended medical purpose subjects it to regulation under the MDR as opposed to cosmetic product regulations.

Example

Classifying an implantable device.

Scenario

A manufacturer develops a new biodegradable bone scaffold intended for long-term implantation to support bone regeneration. Using the classifier, the company can understand that the device likely falls under Class III due to its implantable nature and potential systemic impact, requiring a higher level of scrutiny and clinical evidence.