How to search EUDAMED, verify registrations, and understand MDR/IVDR — with figures from MD Atlas's indexed data.
RSS feedAn eIFU is the instructions for use in electronic form. Since 16 July 2025 any MDR device for professional users may provide one; in the indexed subset, 12% of MDR records link to a web landing page.
Read →In the indexed subset, 219 of 5,875 notified-body certificates (3.7%) are withdrawn, cancelled or suspended in October 2026 — and the share rises with age: 0.7% of 2026 issues, 14.7% of 2021 issues.
Read →MDR classes IIa, IIb and III and IVDR classes C and D need a PSUR — yearly, or every two years for class IIa; class I, A and B need a PMS report. In the indexed subset: 1,097,311 of 2,905,326 records.
Read →Yes, when placed on the market with a medical purpose. In the indexed subset, 99.9% of medical face masks, examination gloves and wheelchairs are class I; 90.5% of contact lenses are class IIa.
Read →An implant's SSCP is published in EUDAMED, linked to its Basic UDI-DI, once the notified body has validated it. In the indexed subset, 1,097 of 1,175 SSCPs exist in English and 21 in French.
Read →In the indexed subset, 835,188 of 3,747,851 device records (22%) are still registered under the MDD, AIMDD or IVDD in October 2026 — and tens of thousands of legacy records still arrive every week.
Read →A procedure pack or system combines CE-marked devices for one medical purpose (MDR Article 22). Its producer files it under a Basic UDI-DI with its own SRN: 1,711 producers in 63 countries.
Read →NANDO is the roster. Of the 69 notified bodies EUDAMED lists and MD Atlas indexes, 52 hold an active MDR designation and 19 an active IVDR one in October 2026; 18 hold both, 16 hold neither.
Read →An importer is the EU-established company that places a device from a third country on the EU market (MDR Article 2(33)). It registers in EUDAMED with its own SRN: 12,800 are indexed in 32 countries.
Read →Usually not. Under MDR Article 52(7) a class I manufacturer self-declares unless the device is sterile, measuring or reusable surgical. Only 252 of 8,204 class-I-only manufacturers hold a certificate.
Read →Across 2.5 million MDR device records in the indexed subset, 18.8% are sterile, 38.1% single-use and 12.0% implantable. Every flag rises with risk class: class III is 81% sterile and 97% single-use.
Read →In the indexed subset, 5,039 notified-body certificates carry an expiry date: 143 fall in 2026, 613 in 2027, then over 1,000 a year from 2028 to 2031. 57% were issued for five years, the MDR maximum.
Read →47% of the 32,254 registered manufacturers in the indexed subset have no device record. Actor and device registration are separate obligations on two clocks; the second runs out on 28 November 2026.
Read →If the manufacturer is not established in the EU, MDR Article 11 requires one. In the indexed subset, 2,968 are registered across 32 countries; Germany, the Netherlands and France host 48% of them.
Read →In the indexed EUDAMED subset, 60.6% of MDR device records are class I and 2.6% are class III. Under the legacy MDD the mix inverts: class IIb leads and class III is 13.8%.
Read →The vigilance module is not live, but the reporting duties are. What the 2, 10 and 15-day clocks require today, and why absence in EUDAMED is not a clean safety record.
Read →A UDI DataMatrix is a string of GS1 Application Identifiers. What each AI means, how fixed and variable-length fields are separated, and how to tell the UDI-DI from the UDI-PI by eye.
Read →Both are UDI registries, but only one also registers companies and certificates. The seven differences that matter when you file in both markets, and the one thing neither database holds.
Read →Legacy devices get until end-2027 or end-2028 — but only if five cumulative conditions were met, and two of those deadlines have already passed. How to check where a device stands.
Read →A handful of notified bodies hold most of the certificates recorded in EUDAMED. Who they are, how concentrated the market really is, and what that means when you are choosing one.
Read →The EU designates four UDI issuing entities. What each one is for, how to choose between them, why the choice is effectively permanent, and what happens to legacy devices that have no UDI at all.
Read →China has more registered device manufacturers than any EU member state. What the country distribution in EUDAMED shows, and why a low count is usually a data artefact rather than an empty market.
Read →An EMDN code is the European nomenclature term attached to a device when it is registered in EUDAMED. How the code is built, how to read it, and how to look one up.
Read →Most registered manufacturers sit outside the EU. The path runs through an authorised representative, in a fixed order: appoint, register the AR, register the manufacturer, then the devices.
Read →EUDAMED is six modules, not one database. Four became mandatory on 28 May 2026; two are still in development. What each one holds, what is public, and which deadlines are still ahead.
Read →Read the NB number after the CE mark, confirm it in NANDO, check the certificate in EUDAMED. The three checks that show a CE certificate is genuine — and why a missing number is fine.
Read →A manufacturer's SRN is public. Search the company by name on EUDAMED's public site — no login — and read its Single Registration Number. How to find it and read its structure.
Read →MDR or IVDR? The intended purpose decides. If your product examines specimens from the body to give information, it is an IVD under the IVDR — otherwise a device under the MDR.
Read →If you supply medical devices — a pharmacy included — you are a distributor under the MDR. Article 14 is the checklist you must run before making a device available, plus why you do not need an SRN.
Read →A competent authority is the national body that enforces the MDR in each EU country. What it does, how it differs from a notified body, how to find yours — and why NB designation lives in NANDO.
Read →Reusable instruments must carry the UDI on the device itself — permanent and readable after every reprocessing cycle. When it applies, the deadlines, and the honest answer on marking metal.
Read →The UDI carrier is the physical mark — barcode, DataMatrix or RFID — that carries the UDI on a device label. What it encodes, where it goes, and the deadlines (Class I since 26 May 2025).
Read →UDI is the EU MDR requirement; GTIN is a GS1 number. If you use GS1, your GTIN becomes the UDI-DI and your GMN the Basic UDI-DI. Here's how the GS1 identifiers map to the regulation.
Read →A UDI has two parts: the UDI-DI identifies the device model, the UDI-PI identifies the production unit. Here's the difference, what each contains, and how they sit on the label under EU MDR.
Read →EUDAMED's public website is open to everyone — no account, no login. Only economic operators submitting data need to sign in. Here's what's public, where to search it, and the law behind it.
Read →The MDR gives small manufacturers no size-based relief — obligations track the device, not the company. The real flexibility is an external PRRC and hybrid org models.
Read →Expert voices · Guest essayMDCG 2026-4 hands SSCP upload to the manufacturer. Beyond the deadlines, EUDAMED becomes a public, NB-validated database of clinical performance — an enforceable state of the art.
Read →EUDAMED is organisation-centric, so you can't look up a person — but you can verify the companies, SRNs, devices and certificates a consultant says they worked on. Here's how.
Read →A quality-management-system certificate attests the manufacturer's QMS — aligned with ISO 13485 — not each device. Here is what it covers, and what it doesn't.
Read →Yes — four EUDAMED modules became mandatory on 28 May 2026, with device and certificate deadlines running through 2027. Here is the timeline and what it means.
Read →Software with a medical purpose is a device under the MDR. Rule 11 of Annex VIII puts most decision-driving software in Class IIa, rising to IIb or III with the severity of harm.
Read →The IVDR sorts every in vitro diagnostic into class A, B, C or D by risk, using the Annex VIII rules. Here is what each class means and how IVDR devices break down in EUDAMED.
Read →Basic UDI-DI groups a device family; UDI-DI identifies a specific variant. Here is what each one does, why both exist, and how they organise devices in EUDAMED.
Read →A notified-body certificate sits behind the CE mark of higher-risk medical devices. Here's what one records, what its status means, and how to check it in EUDAMED.
Read →The SRN is the unique ID every EUDAMED actor receives. Here is how to read its structure, who needs one, and how to verify a manufacturer in seconds.
Read →EUDAMED is the European Commission database for medical devices under the MDR and IVDR. Here is what it covers and how to search it in seconds.
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