Free Moldova medical device classification tool

What the Moldova classifier checks

How are medical devices classified in Moldova?

AMDM uses a risk-based framework. Possible classes include Class I, Class IIA, Class IIB, Class III. The national class axis of Legea nr. 102 din 09 iunie 2017 cu privire la dispozitivele medicale and its implementing regulation HG nr. 702 din 11.07.2018, not the EU MDR. AMDM states on its own page that devices are grouped into classes I, IIA, IIB and III according to the risks of use, on the basis of the 18 Rules, and that a registration dossier may group devices in one application only where the intended purpose, the manufacturer and the risk class are all the same. The same page states that medical devices bearing the CE marking are placed on the market by way of the registration procedure — that is, the CE marking is an input to the national procedure and does not remove it. The Agency's current administrative framework for devices bearing the CE marking is Ordinul nr. Rg04-264 din 08.09.2026, which the Agency describes as aligned with the principles and requirements of the relevant European framework, including Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), while remaining a national notification and registration procedure conducted in the State Register. Moldova is an EU candidate state, not a member, and the MDR is not directly applicable. In vitro diagnostic devices are classified on a separate axis by Legea nr. 102/2017 art. 9 alin. (5) (list A, list B, self-testing devices not in list A or B, other IVDs), recorded in the fact classification-in-vitro-diagnostic-lists (the analyte lists of HG nr. 703/2018 were not read from an official copy, so no IVD scheme is published); their marketing regulation is HG nr. 703 din 11.07.2018, named on both the Agency's and the ministry's official indexes. 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 Moldova classifier use?

Current AMDM requirements and class information from similar registered products. Your result includes an explanation and links to the official sources used.

Is the result an official AMDM 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.