{"id":1549,"date":"2026-09-14T21:16:16","date_gmt":"2026-09-14T19:16:16","guid":{"rendered":"https:\/\/helenaolbertova.com\/?page_id=1549"},"modified":"2026-09-14T22:03:13","modified_gmt":"2026-09-14T20:03:13","slug":"eudamed","status":"publish","type":"page","link":"https:\/\/helenaolbertova.com\/cs\/eudamed\/","title":{"rendered":"Registrace v syst\u00e9mu EUDAMED"},"content":{"rendered":"
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EUDAMED<\/p>\n\n\n\n

EUDAMED Registration for IVD Manufacturers<\/h1>\n\n\n\n

Devices placed on the EU market before 28 May 2026 are to be registered in EUDAMED by 27 November 2026. New devices are registered before they are placed on the market, and registration continues as an ongoing obligation for every product that follows.<\/p>\n\n\n\n

I support both situations: the current registration push, and the routine registrations that come afterwards. Once the portfolio grows, manual entry stops being the fastest route and starts being the one most likely to introduce errors.<\/p>\n<\/div>\n\n\n\n

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Why It Takes Longer Than People Expect<\/h2>\n\n\n\n

Manufacturers who have started usually run into the same handful of things, and none of them is the upload itself.<\/p>\n\n\n\n

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The Data Is Not Sitting Ready<\/h3>\n\n\n\n

It exists, but spread across labelling files, ERP, and technical documentation, in different formats and sometimes in different versions. Collecting it, and agreeing which version is the correct one, is the part nobody budgets for.<\/p>\n<\/div>\n<\/div>\n\n\n\n

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UDI Has to Match Everything Else<\/h3>\n\n\n\n

The information has to agree with your technical documentation and your labelling exactly. Mismatches surface late, and correcting them touches more than the database entry.<\/p>\n<\/div>\n<\/div>\n\n\n\n

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Legacy Devices Work Differently<\/h3>\n\n\n\n

They follow different identification rules, using a EUDAMED-DI and EUDAMED-ID rather than a Basic UDI-DI. Easy to get wrong on the first attempt, and tedious to unpick afterwards.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Decisions Nobody Has Made Yet<\/h3>\n\n\n\n

What goes on the label, how storage and warning information is worded, how product families are grouped. These answers often differ between departments, and EUDAMED forces one version. Every change parked for later has to be either done now or dropped, otherwise the registration you just completed needs updating within weeks.<\/p>\n<\/div>\n<\/div>\n\n\n\n

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Manual Entry Gets Risky at Volume<\/h3>\n\n\n\n

Typing the same fields into a browser a few hundred times is not only slow, it is where transposed digits and copied-down values come from. A mistake in a database record is noticed late and corrected slowly, and correcting it usually touches the documentation behind it too.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Two Routes<\/p>\n\n\n\n

Done For You, or Done With You<\/h2>\n\n\n\n
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Done For You<\/p>\n\n\n\n

XML Batch Upload<\/h3>\n\n\n\n

You fill in my detailed Excel template with your product information. I convert it into correctly formatted XML and either handle the upload myself or hand you the file to upload.<\/p>\n\n\n\n