https://eudamedai.com/ weekly 1.0 https://eudamedai.com/og-eudamedai-sl.png EUdaMed AI — skladnost MDR in IVDR https://eudamedai.com/media/logo-square.png EUdaMed AI logotip https://eudamedai.com/media/pregled-obrazca-poster.jpg Pregled obrazca za skladnost pripomočka https://eudamedai.com/media/plan-vzorcenja-poster.jpg Triletni plan vzorčenja https://eudamedai.com/media/capa-poster.jpg Vodenje ukrepov CAPA https://eudamedai.com/media/zajem-gradiva-poster.jpg Zajem gradiva o pripomočku https://eudamedai.com/media/telefon-poster.jpg Zajem etikete s telefonom https://eudamedai.com/media/kontrolni-seznam-p1.jpg Kontrolni seznam za pregled skladnosti https://eudamedai.com/mdr-skladnost-distributerji monthly 0.9 https://eudamedai.com/ivdr-skladnost-uvozniki monthly 0.9 https://eudamedai.com/eudamed-registracija-2026 monthly 0.9 https://eudamedai.com/blog/preverjanje-skladnosti-termometra monthly 0.8 https://eudamedai.com/en/medical-device-distributor-compliance monthly 0.8 https://eudamedai.com/blog daily 0.9 https://eudamedai.com/zasebnost monthly 0.5 https://eudamedai.com/blog/tema/obveznosti weekly 0.7 https://eudamedai.com/blog/tema/pregled-skladnosti weekly 0.7 https://eudamedai.com/blog/tema/eudamed-udi weekly 0.7 https://eudamedai.com/blog/tema/oznacevanje weekly 0.7 https://eudamedai.com/blog/tema/vigilanca weekly 0.7 https://eudamedai.com/blog/tema/prehodna-obdobja weekly 0.7 https://eudamedai.com/blog/tema/inspekcija weekly 0.7 https://eudamedai.com/blog/verifying-notified-body-certificates-for-medical-devices-and 2026-09-26T06:00:23.014Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Verifying Notified Body Certificates for Medical Devices and IVDs https://eudamedai.com/blog/basic-udi-di-udi-di-difference 2026-09-24T06:00:28.790Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Basic UDI-DI and UDI-DI: What Each Identifier Does and Where It Is Checked https://eudamedai.com/blog/mdr-za-distributerje-obveznosti-in-dokazila 2026-09-22T06:00:27.776Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png MDR za distributerje: obveznosti in dokazila https://eudamedai.com/blog/eudamed-actor-registration-srn 2026-09-19T06:00:18.969Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png EUDAMED Actor Registration and the Single Registration Number (SRN) https://eudamedai.com/blog/legacy-device-registration-eudamed-importer-distributor-duti 2026-09-17T06:00:39.442Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Legacy device registration in EUDAMED: importer and distributor duties https://eudamedai.com/blog/mdr-skladnost-za-distributerje-kaj-zahteva-14-clen 2026-09-15T06:00:29.359Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png MDR skladnost za distributerje: kaj zahteva 14. člen https://eudamedai.com/blog/mdr-audit-preparation-distributor 2026-09-12T06:00:29.871Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Evidence an auditor or authority will ask for: MDR audit preparation for distributors https://eudamedai.com/blog/when-spreadsheets-stop-being-defensible-for-eu-medical-devic 2026-09-10T06:00:26.519Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png When Spreadsheets Stop Being Defensible for EU Medical Device Compliance https://eudamedai.com/blog/preverjanje-veljavnosti-certifikata-priglasenega-organa-nand 2026-09-08T06:00:32.525Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Preverjanje veljavnosti certifikatov priglašenih organov NANDO https://eudamedai.com/blog/how-to-size-a-risk-based-annual-sampling-plan-medical-device 2026-09-05T06:00:25.208Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Sizing a Risk-Based Annual Sampling Plan for Medical Devices in the EU https://eudamedai.com/blog/why-the-ce-mark-alone-is-not-evidence-of-conformity 2026-09-03T06:00:24.677Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Why the CE mark alone is not evidence of conformity https://eudamedai.com/blog/kaj-je-udi-kje-se-preverja-in-kaj-mora-ujemati 2026-09-01T06:00:48.186Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Kaj je UDI, kje se preverja in kaj mora ujemati https://eudamedai.com/blog/incoming-goods-inspection-medical-devices 2026-08-29T06:00:23.041Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Incoming Goods Inspection for Medical Devices: A Repeatable Verification Process https://eudamedai.com/blog/how-to-define-and-document-a-sampling-method-for-medical-dev 2026-08-27T06:00:21.855Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png How to define and document a sampling method for medical devices under MDR https://eudamedai.com/blog/kdo-mora-registrirati-legacy-pripomocki-eudamed 2026-08-25T06:00:31.740Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Kdo mora registrirati legacy pripomočke v EUDAMED https://eudamedai.com/blog/prrc-role-and-requirements 2026-08-22T06:00:21.124Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Who needs a PRRC and what the role covers https://eudamedai.com/blog/medical-device-distributor-incoming-goods-checklist 2026-08-20T06:01:17.436Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png A practical checklist for the incoming goods process https://eudamedai.com/blog/registering-devices-already-on-the-market-eudamed-november-2 2026-08-19T11:00:51.399Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Registering Devices Already on the Market in EUDAMED by 27 November 2026 https://eudamedai.com/blog/registracija-pripomockov-ze-na-trgu-eudamed 2026-08-19T11:00:23.724Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Registracija pripomočkov, ki so že na trgu, v EUDAMED do 27. novembra 2026 https://eudamedai.com/blog/registracija-eudamed-uvoznik-distributer 2026-08-18T06:00:31.306Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Registracija v EUDAMED: Razlike med uvoznikom in distributerjem https://eudamedai.com/blog/obveznosti-uvoznika-po-13-clenu-mdr-ivdr 2026-08-17T15:00:30.483Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Obveznosti uvoznika po 13. členu MDR in IVDR https://eudamedai.com/blog/kdaj-excel-ne-zadostuje-vec 2026-08-17T14:59:33.942Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Kdaj Excel ne zadošča več: programska oprema za skladnost medicinskih pripomočkov https://eudamedai.com/blog/seznam-dokumentov-inspekcija-jazmp-medicinski-pripomocki 2026-08-17T14:58:35.624Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Seznam dokumentov, ki jih morate imeti pripravljene za inšpekcijo JAZMP https://eudamedai.com/blog/evidenca-izvedbe-pregleda-skladnosti-medicinskih-pripomockov 2026-08-17T14:56:59.956Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Katera dokazila mora imeti podjetje: Evidenca izvedbe pregleda skladnosti medicinskih pripomočkov https://eudamedai.com/blog/sprozilci-izrednega-pregleda-medicinskega-pripomocka 2026-08-17T14:56:30.690Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Sprožilci izrednega pregleda v praksi https://eudamedai.com/blog/prehodna-obdobja-mdr-in-ivdr-kaj-preveriti 2026-08-14T10:00:49.000Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Prehodna obdobja MDR in IVDR: kaj mora preveriti distributer https://eudamedai.com/blog/simboli-na-medicinskih-pripomockih-en-iso-15223-1 2026-08-14T10:00:49.000Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Simboli na oznaki: kaj pregledati po EN ISO 15223-1 https://eudamedai.com/blog/eudamed-registracija-srn-kdo-se-mora-registrirati 2026-08-14T09:47:33.378Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png EUDAMED in številka SRN: kdo se mora registrirati in kje https://eudamedai.com/blog/reprezentativno-vzorcenje-medicinskih-pripomockov 2026-08-14T09:47:33.378Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Reprezentativno vzorčenje: kako določiti metodo in jo dokumentirati https://eudamedai.com/blog/zakaj-zaupanje-oznaki-ce-ne-zadostuje-obveznosti-distributer 2026-08-14T10:26:17.129Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Zakaj zaupanje oznaki CE ne zadošča: Obveznosti distributerja po sodbi Sodišča EU https://eudamedai.com/blog/importer-obligations-mdr-article-13 2026-08-14T10:25:46.636Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Importer Obligations for Medical Devices Under MDR Article 13 https://eudamedai.com/blog/eudamed-obvezna-uporaba-distributerji-uvozniki-2026 2026-08-14T10:25:19.257Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Kaj se je spremenilo za distributerje in uvoznike z obvezno uporabo modulov EUDAMED https://eudamedai.com/blog/cjeu-ruling-distributor-verification-obligations-mdr 2026-08-14T10:24:54.038Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png CJEU Ruling: Distributors Must Not Rely Solely on the CE Mark https://eudamedai.com/blog/eudamed-mandatory-distributors-importers-may-2026 2026-08-14T10:24:46.751Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png What changes for distributors and importers now that EUDAMED modules are mandatory https://eudamedai.com/blog/distributor-obligations-mdr-article-14 2026-08-14T10:21:35.813Z monthly 0.8 https://eudamedai.com/og-eudamedai-en.png Distributor Obligations: Verifying Medical Devices Under MDR Article 14 https://eudamedai.com/blog/letni-plan-vzorcenja-medicinskih-pripomockov 2026-08-14T10:10:27.984Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Kako sestaviti plan vzorčenja po tveganju za medicinske pripomočke https://eudamedai.com/blog/kazenske-dolocbe-odgovornost-zmedpri-1 2026-08-14T10:08:11.649Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Kazenske določbe in odgovornost odgovornih oseb po Zakonu o medicinskih pripomočkih-1 https://eudamedai.com/blog/odgovorna-oseba-za-skladnost-medicinskih-pripomockov-vloga-i 2026-08-14T10:08:02.263Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Odgovorna oseba za skladnost medicinskih pripomočkov: Vloga in obveznosti https://eudamedai.com/blog/kdaj-ste-distributer-in-kdaj-uvoznik-medicinskih-pripomockov 2026-08-14T10:07:24.495Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Kdaj ste distributer in kdaj uvoznik medicinskih pripomočkov v EU https://eudamedai.com/blog/inspekcija-jazmp-katera-dokazila-pripraviti 2026-08-14T09:35:59.402Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Inšpekcija JAZMP: katera dokazila morate imeti pripravljena https://eudamedai.com/blog/obveznosti-distributerja-in-uvoznika-medicinskih-pripomockov 2026-08-14T07:35:59.402Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Obveznosti distributerja in uvoznika medicinskih pripomočkov https://eudamedai.com/blog/pregled-skladnosti-medicinskega-pripomocka 2026-08-14T05:35:59.402Z monthly 0.8 https://eudamedai.com/og-eudamedai-sl.png Pregled skladnosti medicinskega pripomočka: kaj preveriti in kako to dokazati