Free Malta medical device classification tool

What the Malta classifier checks

How are medical devices classified in Malta?

Medicines Authority uses a risk-based framework. Possible classes include IVDs: IVD Class A, IVD Class B, IVD Class C, IVD Class D; Medical devices: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III. National projection of the directly applicable EU IVDR classification. The canonical class axis and rules are maintained in eu:ivd, and the Maltese instruments apply the IVDR classes as such rather than renaming them: S.L. 458.59 defines 'in-vitro diagnostic medical device' only by reference to paragraph 2 of Article 2 of Regulation (EU) 2017/746 and adds no national class axis, so the class labels here are the canonical IVD Class A to IVD Class D. The Maltese references describe only administration and the national registration overlay. National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; the Maltese references describe only administration, the national registration overlay and the optional paid classification-confirmation service. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Malta classifier use?

Current official Medicines Authority classification requirements. Your result includes an explanation and links to the official sources used.

Is the result an official Medicines Authority classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.