Free AI tool · No signupFree Iceland medical device classification tool
Describe your device and get a preliminary Lyfjastofnun risk class, a clear explanation, official source links, and similar registered products where available.
Free · no loginStructured outputOfficial source linksRegistry evidence where available
Describe your device
Try an example
Tell us what the device does, who uses it, how it contacts the body, and whether it is powered, implantable, sterile, measuring, software, or an IVD.
Preliminary informational result — not an official regulatory decision.0 / 5,000
About this classifier
What the Iceland classifier checks
The classifier compares your product description with current Lyfjastofnun classification requirements. It then gives you a suggested class, explains why it may apply, and shows the source links and product examples behind the result.
- How are medical devices classified in Iceland?
- Lyfjastofnun 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. Regulation (EU) 2017/746 is in force in Iceland from 26 May 2022 and is made law by lög um lækningatæki nr. 132/2020, with the instruments and their EEA Joint Committee decisions listed in reglugerð nr. 907/2022. IVDs are divided into classes A, B, C and D, where A is the lowest and D the highest risk, and Class A that is not sterile and has no measuring function carries no notified-body involvement. The canonical class axis and rules are maintained in eu:ivd; this scheme carries only the Icelandic references. National projection of the directly applicable EU MDR classification. Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561, 'as they are taken up in the Agreement on the European Economic Area', have the force of law in Iceland under 2. gr. laga um lækningatæki nr. 132/2020, and reglugerð nr. 907/2022 lists the instruments and the EEA Joint Committee decision that took each into the Agreement. Iceland is an EEA/EFTA State and not an EU member State, so the classification rules reach the Icelandic market through Iceland's own act of incorporation rather than by direct applicability. The canonical class axis and rules are maintained in eu:medical-device; this scheme carries no national delta to them, and only the national references below describe administration or local duties. 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 Iceland classifier use?
- Current official Lyfjastofnun classification requirements. Your result includes an explanation and links to the official sources used.
- Is the result an official Lyfjastofnun 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.
Keep researching this market
More Iceland medical device resources
Continue with this market