Seller Guardrails · EU MDR Annex VIII

Classify your medical device against MDR Annex VIII

Answer the device intake; watch Annex VIII rules 1–22 resolve on the right. Each applying rule cites its Annex excerpt and contributes to the highest class. The final seal carries the notified-body route + UK/CH equivalents.

MDR Annex VIII rule corpus verified 2026-06-09. Cross-check EUR-Lex + MDCG 2021-24 before filing your Declaration of Conformity.

Fill the device intake on the left; each Annex VIII rule will resolve here.

Rule 1 · Non-invasive devices — general
Rule 2 · Channelling or storing for administration
Rule 3 · Modifying biological/chemical composition
Rule 4 · Contact with injured skin or mucous membrane
Rule 5 · Body orifice (non-surgical) invasive
Rule 6 · Surgically invasive — transient use
Rule 7 · Surgically invasive — short-term use
Rule 8 · Surgically invasive — long-term / implantable
Rule 9 · Active therapeutic — energy exchange
Rule 10 · Active for diagnosis or monitoring
Rule 11 · Software (MDSW)
Rule 12 · Active — administer or remove substances
Rule 13 · All other active devices
Rule 14 · Devices incorporating a medicinal substance
Rule 15 · Contraception, STI prevention
Rule 16 · Disinfecting / sterilising medical devices
Rule 17 · Recording diagnostic images
Rule 18 · Devices using non-viable biological material
Rule 19 · Devices incorporating nanomaterial
Rule 20 · Invasive via orifice — inhalation
Rule 21 · Substances introduced via body orifice / on skin
Rule 22 · Active therapeutic with integrated diagnostic functions

Provide device characteristics to compute the class.

€49 PDF report — full technical-file scope

The verdict above is the public preview. Purchase the €49 audit-defensible PDF for: every applying rule with verbatim Annex VIII text + MDCG 2021-24 citation, the Annex II technical documentation outline, the Annex III post-market surveillance plan, the conformity-assessment route per Annex IX/X/XI, UDI obligations under Art. 27, and PMCF expectations per Annex XIV Part B.

This tool is decision support, not legal advice. MDR Art. 51 places classification responsibility on the manufacturer. The Annex VIII rule corpus is refreshed quarterly; the dataset_pin date is the last verification against EUR-Lex + MDCG 2021-24. For Class IIa/IIb/III devices you must engage a notified body before placing the device on the EU market.