https://www.cepartner4u.com/new-guidance-on-software/2020-06-04T09:11:33+02:00https://www.cepartner4u.com/the-new-blue-guide/2020-11-19T21:16:02+01:00https://www.cepartner4u.com/new-updated-harmonized-standards/2020-11-19T22:26:40+01:00https://www.cepartner4u.com/rohs-2-applicable-for-medical-devices-per-22-july-2014/2020-06-04T09:11:33+02:00https://www.cepartner4u.com/updated-code-of-conduct-notified-bodies/2025-01-09T10:47:52+01:00https://www.cepartner4u.com/new-updated-harmonized-standards-2/2020-06-04T09:11:33+02:00https://www.cepartner4u.com/updated-meddev-guidance-on-clinical-evaluation/2020-06-04T09:11:33+02:00https://www.cepartner4u.com/updated-meddev-guidance-on-software/2020-06-04T09:11:33+02:00https://www.cepartner4u.com/publication-of-mdr/2020-06-04T09:11:33+02:00https://www.cepartner4u.com/publication-of-ivdr/2020-06-04T09:11:17+02:00https://www.cepartner4u.com/new-manual-borderline-and-classification-vs-1-18/2020-06-04T09:11:17+02:00https://www.cepartner4u.com/mdcg-issues-draft-guidance-on-basic-udi-di-2018-1/2020-06-04T09:11:17+02:00https://www.cepartner4u.com/mdcg-issues-draft-guidance-on-european-nomenclature-2018-2/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/factsheets-for-manufacturers-of-md-and-ivd/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/mdcg-endorses-5-new-documents/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/new-manual-borderline-and-classification-vs-1-19/2020-06-04T09:11:17+02:00https://www.cepartner4u.com/new-manual-borderline-and-classification-vs-1-20/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/guidance-for-products-without-an-intended-purpose-mdr-annex-xvi/2020-11-19T21:25:37+01:00https://www.cepartner4u.com/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/bsi-first-uk-notifed-body-to-achieve-successful-mdr-designation/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/uk-government-medical-device-regulation-after-no-deal-brexit/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/new-manual-borderline-and-classification-1-22/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/guidance-on-symbols-for-mdr-ivdr-labels/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/mdcg-issues-guide-for-summary-of-safety-and-clinical-performance/2020-06-04T09:11:16+02:00https://www.cepartner4u.com/call-for-expression-of-interest-for-expert-panels-on-medical-devices-and-in-vitro-diagnostic-medical-devices/2020-06-04T09:11:15+02:00https://www.cepartner4u.com/designated-notified-bodies-for-mdr-and-ivdr/2020-11-19T20:58:22+01:00https://www.cepartner4u.com/mdcg-software-guidance/2020-11-19T21:07:54+01:00https://www.cepartner4u.com/publication-eudamed-delayed/2020-06-04T09:11:15+02:00https://www.cepartner4u.com/consolidated-mdr-now-available-2020-04-24/2025-01-14T13:55:14+01:00https://www.cepartner4u.com/common-specification-for-reprocessing-of-single-use-devices/2021-02-09T13:14:43+01:00https://www.cepartner4u.com/sgs-fimko-oy-18th-nb-under-the-mdr/2024-10-10T10:11:23+02:00https://www.cepartner4u.com/ec-issues-new-guidance-on-registering-and-identifying-legacy-devices-in-eudamed/2021-03-01T13:59:54+01:00https://www.cepartner4u.com/mdcg-2021-1-guidance-on-administrative-practices-until-eudamed-is-fully-functional/2021-05-10T14:30:39+02:00https://www.cepartner4u.com/8480/2021-03-02T10:01:20+01:00https://www.cepartner4u.com/2021-european-commission-notice-on-remote-audits-mdr-ivdr/2021-03-02T10:34:06+01:00https://www.cepartner4u.com/mhra-issued-guidance-2-0-on-applying-human-factors-to-medical-devices/2021-04-20T12:50:54+02:00https://www.cepartner4u.com/new-ivd-symbols-for-compliance-with-the-ivdr/2021-03-02T11:42:49+01:00https://www.cepartner4u.com/mdcg-2021-4-qa-class-d-ivd-during-transition-to-ivdr-rev1/2024-09-27T10:49:12+02:00https://www.cepartner4u.com/mdcg-2021-5-standardisation-medical-devices-rev1/2024-07-02T14:50:53+02:00https://www.cepartner4u.com/guidance-on-clinical-trials-during-covid-19/2021-04-20T12:42:45+02:00https://www.cepartner4u.com/mdcg-2021-6-mdr-questions-answers-clinical-investigation-rev011/2023-12-14T15:01:54+01:00https://www.cepartner4u.com/mdcg-2018-1-rev-4-guidance-on-basic-udi-di-and-changes-to-udi-di/2021-05-04T14:32:30+02:00https://www.cepartner4u.com/european-commission-publishes-factsheet-for-class-i-medical-devices/2021-05-04T15:04:49+02:00https://www.cepartner4u.com/mdcg-2021-7-notice-warns-ivd-manufacturers-of-covid-19-variant-responsibilities/2021-05-18T19:06:33+02:00https://www.cepartner4u.com/the-udi-helpdesk-is-live/2021-05-24T21:58:36+02:00https://www.cepartner4u.com/mdcg-2021-08-clinical-investigation-application-notification-documents/2021-05-24T22:04:48+02:00https://www.cepartner4u.com/imdrf-posts-wg-n65final2021-on-post-market-clinical-follow-up-studies/2021-05-27T16:34:50+02:00https://www.cepartner4u.com/team-nb-members-adopted-a-position-paper-with-considerations-on-conformity-assessment-for-class-d-devices/2021-06-03T14:43:27+02:00https://www.cepartner4u.com/mdcg-2021-9-position-paper-published-on-the-implementation-of-udi-requirements-for-contact-lenses/2021-06-03T17:08:15+02:00https://www.cepartner4u.com/update-of-the-eu-turkey-customs-union-for-medical-devices/2021-09-20T16:53:15+02:00https://www.cepartner4u.com/status-of-the-eu-switzerland-mutual-recognition-agreement-mra/2021-06-07T15:43:12+02:00https://www.cepartner4u.com/mdcg-published-joint-implementation-plan-on-ivdr/2022-04-04T14:09:32+02:00https://www.cepartner4u.com/mdcg-2021-12-faq-on-emdn/2025-02-11T14:35:18+01:00https://www.cepartner4u.com/mdcg-2021-10-status-appendixes-e-i-imdrf-n48/2021-06-08T12:02:14+02:00https://www.cepartner4u.com/mdcg-2021-13-qa-on-actor-id/2021-07-19T15:47:21+02:00https://www.cepartner4u.com/dekra-certification-bv-5th-eu-notified-body-under-the-ivdr/2021-06-29T18:04:08+02:00https://www.cepartner4u.com/mdcg-2021-23-guidance-on-certification-activities-mdr-ivdr/2021-08-26T14:06:19+02:00https://www.cepartner4u.com/new-forms-for-notified-bodies-in-the-scope-of-the-mdr-and-the-ivdr/2021-08-26T15:33:05+02:00https://www.cepartner4u.com/mdcg-2021-20-civ-id-for-mdr-clinical-investigations/2021-08-26T15:44:57+02:00https://www.cepartner4u.com/mdcg-2021-22-clarification-on-first-certification-ivdr/2021-08-26T16:15:17+02:00https://www.cepartner4u.com/mdcg-2021-21-guidance-on-performance-evaluation-of-sars-cov-2-in-vitro-diagnostic-medical-devices/2021-08-26T16:20:26+02:00https://www.cepartner4u.com/cen-and-cenelec-announced-a-new-website/2021-09-13T11:08:10+02:00https://www.cepartner4u.com/medtech-europe-survey-ivd-manufacturer/2021-09-20T16:45:15+02:00https://www.cepartner4u.com/mdcg-2021-19-guidance-note-integration-of-the-udi-within-an-organisations-quality-management-system/2021-09-20T16:21:22+02:00https://www.cepartner4u.com/mdcg-2021-11-guidance-on-implant-card-device-types/2021-09-20T16:38:01+02:00https://www.cepartner4u.com/new-standard-en-iso-204172021-information-to-be-supplied-by-the-manufacturer/2021-09-20T16:57:46+02:00https://www.cepartner4u.com/mdcg-2021-24-guidance-on-classification-of-medical-devices/2021-10-07T17:28:16+02:00https://www.cepartner4u.com/eudamed-2-new-modules-available/2021-10-07T17:36:30+02:00https://www.cepartner4u.com/mdcg-2021-25/2024-10-29T11:31:53+01:00https://www.cepartner4u.com/mdcg-2021-26-qa-on-re-packaging-and-re-labelling-activities/2021-10-26T14:35:52+02:00https://www.cepartner4u.com/european-commission-implementing-regulation-eu-2021-2078-eudamed/2021-12-02T18:05:29+01:00https://www.cepartner4u.com/mdcg-2021-27-and-mdcg-2021-28-published-by-european-commission/2023-12-19T17:17:03+01:00https://www.cepartner4u.com/european-commission-press-release-on-ivdr-transitional-periods/2021-12-21T17:52:48+01:00https://www.cepartner4u.com/medtech-europe-publishes-use-of-symbols-to-indicate-compliance-with-the-mdr-v3-0/2021-12-21T18:08:28+01:00https://www.cepartner4u.com/medtech-europe-issues-2nd-edition-of-the-clinical-evidence-requirements-for-ce-certification-under-the-ivdr/2021-12-21T18:21:05+01:00https://www.cepartner4u.com/press-release-european-commission-proposes-a-progressive-roll-out-of-the-new-ivdr/2021-12-21T18:36:18+01:00https://www.cepartner4u.com/mdcg-2022-2-guidance-on-clinical-evidence-ivds-published/2022-02-10T15:05:17+01:00https://www.cepartner4u.com/publication-in-official-journal-of-the-european-union-about-the-transitional-periods-of-the-ivdr/2022-02-15T14:50:00+01:00https://www.cepartner4u.com/mdcg-verification-of-manufactured-class-d-ivds-by-notified-bodies-rev1/2024-12-18T20:30:17+01:00https://www.cepartner4u.com/notified-body-surveillance-of-mdr-legacy-devices/2022-03-07T14:49:41+01:00https://www.cepartner4u.com/new-regulation-about-electronic-user-instructions-of-medical-devices/2022-03-07T14:55:12+01:00https://www.cepartner4u.com/mdcg-publishes-revision-1-of-2019-9-about-sscp/2022-03-28T11:23:54+02:00https://www.cepartner4u.com/mdcg-2022-6-published-on-guidance-on-significant-changes-regarding-the-transitional-provision-under-article-1103-of-the-ivdr/2022-05-05T17:42:10+02:00https://www.cepartner4u.com/mdcg-2022-5-published-on-mdr-borderline-products-medical-devices-and-medicinal-products/2024-10-29T11:30:10+01:00https://www.cepartner4u.com/3-new-mdcg-documents-published/2022-05-23T18:46:34+02:00https://www.cepartner4u.com/notice-to-manufacturers-to-ensure-timely-compliance-with-mdr-requirements/2023-11-30T10:48:06+01:00https://www.cepartner4u.com/mdcg-published-a-qa-on-the-interface-between-regulation-eu-536-2014-on-clinical-trials-for-medicinal-products-for-human-use-ctr-and-regulation-eu-2017-746-on-in-vitro-diagnostic-medical-devices/2022-06-28T16:54:54+02:00https://www.cepartner4u.com/commission-publishes-information-on-the-status-of-the-eu-switzerland-mutual-recognition-agreement-mra-for-in-vitro-diagnostic-medical-devices/2022-06-28T17:00:44+02:00https://www.cepartner4u.com/obligations-for-authorised-representatives-importers-and-distributors/2022-06-28T17:09:13+02:00https://www.cepartner4u.com/8938/2022-07-04T10:39:50+02:00https://www.cepartner4u.com/published-mdcg-2022-12-guidance-on-harmonised-administrative-practices-and-alternative-technical-solutions-until-eudamed-is-fully-functional-ivdr/2022-07-26T17:15:12+02:00https://www.cepartner4u.com/manual-borderline-v4/2025-09-16T16:46:45+02:00https://www.cepartner4u.com/mdcg-2022-13-revision1/2024-06-17T17:19:03+02:00https://www.cepartner4u.com/mdcg-2022-14-transition-to-the-mdr-and-ivdr-notified-body-capacity-and-availability-of-medical-devices-and-ivds/2022-09-13T16:32:31+02:00https://www.cepartner4u.com/medtech-published-recommendations-on-the-use-of-guidance-documents/2022-10-27T14:17:43+02:00https://www.cepartner4u.com/mdcg-2022-15-issued-on-guidance-on-appropriate-surveillance-regarding-the-transitional-provisions-under-article-110-of-the-ivdr/2022-11-08T16:55:52+01:00https://www.cepartner4u.com/mdcg-issues-new-revision-of-mdcg-2021-22/2025-02-11T14:26:21+01:00https://www.cepartner4u.com/two-commission-implementing-regulations-concerning-devices-without-an-intended-medical-purpose/2022-12-12T12:22:10+01:00https://www.cepartner4u.com/who-issues-global-atlas-of-medical-devices-2022/2022-12-12T11:08:39+01:00https://www.cepartner4u.com/regulation-eu-2022-1107-issued-on-ivdr-common-specifications-for-certain-class-d-devices/2022-12-12T11:19:50+01:00https://www.cepartner4u.com/2-new-mdcg-documents-issued-mdcg-2022-17-and-mdcg-2022-18/2022-12-12T12:11:16+01:00https://www.cepartner4u.com/mdcg-2022-16-guidance-on-authorised-representatives-mdr-and-ivdr-issued/2022-12-12T12:21:28+01:00https://www.cepartner4u.com/mdcg-published-guidance-regarding-documents-to-be-provided-when-an-ivdr-performance-study-is-to-be-conducted/2022-12-14T12:52:37+01:00https://www.cepartner4u.com/mdcg-published-guidance-concerning-a-substantial-modification-of-a-performance-study-under-the-ivdr/2022-12-14T12:55:06+01:00https://www.cepartner4u.com/news-mdcg-2022-21/2022-12-19T12:25:08+01:00https://www.cepartner4u.com/january-6-2023-press-release-of-european-commission-public-health-more-time-to-certify-medical-devices-to-mitigate-risks-of-shortages/2023-01-09T17:14:13+01:00https://www.cepartner4u.com/mdcg-2020-16-rev-4/2025-03-24T12:05:20+01:00https://www.cepartner4u.com/mdcg-issued-2023-3-rev2/2025-01-09T10:42:45+01:00https://www.cepartner4u.com/qa-published-on-mdr-extension-in-regulation-eu2023-607/2023-07-18T14:12:17+02:00https://www.cepartner4u.com/mhra-infographic-timelines/2023-07-31T17:06:17+02:00https://www.cepartner4u.com/manufacturers-declaration-in-relation-to-regulation-eu-2023-607/2024-07-25T15:19:55+02:00https://www.cepartner4u.com/application-mdr-article-97/2023-08-17T15:43:40+02:00https://www.cepartner4u.com/mdcg-revised-guidance-2022-4/2024-06-17T11:50:43+02:00https://www.cepartner4u.com/mdcg-revised-guidance-2020-3/2023-08-17T16:33:51+02:00https://www.cepartner4u.com/notified-body-confirmation-letter-2023-607-2024-1860/2024-07-29T14:38:55+02:00https://www.cepartner4u.com/mdcg-published-2023-2-list-of-standard-fees-nb/2023-08-29T11:33:32+02:00https://www.cepartner4u.com/mdcg-2023-1-guidance-on-the-health-institution-exemption-under-article-55-of-the-mdr-and-ivdr/2023-08-29T11:40:45+02:00https://www.cepartner4u.com/guidance-summary-clinical-investigation-report/2023-08-29T11:44:56+02:00https://www.cepartner4u.com/qa-mdr-annex-xvi/2023-10-09T17:48:26+02:00https://www.cepartner4u.com/mdcg-2023-4-medical-device-software-mdsw-hardware-combinations/2023-10-23T09:51:11+02:00https://www.cepartner4u.com/news-regulation-eu-2023-2197/2023-10-23T11:49:03+02:00https://www.cepartner4u.com/mdcg-2023-5-and-mdcg-6-guidances-published-on-annex-xvi-products/2023-12-14T15:11:46+01:00https://www.cepartner4u.com/2023-2713-regulation-reference-laboratories/2023-12-14T15:27:31+01:00https://www.cepartner4u.com/imdrf-personalized-medical-devices-regulatory-pathways/2024-01-04T16:32:15+01:00https://www.cepartner4u.com/team-nb-agreement-manufacturer-outgoing-mdd-nb-incoming-mdr-nb/2024-01-04T16:35:37+01:00https://www.cepartner4u.com/flowchart-art120-mdr/2024-01-04T16:43:27+01:00https://www.cepartner4u.com/rev2-mdr-and-ivdr-language-requirements-for-manufacturers-published/2024-09-16T18:22:18+02:00https://www.cepartner4u.com/ec-proposes-to-extend-transition-periods-for-certain-ivds-gradual-roll-out-of-eudamed-and-an-information-obligation-in-case-of-interruption-of-supply/2024-01-23T15:02:20+01:00https://www.cepartner4u.com/mdcg-guidances-on-device-specific-vigilance/2024-06-17T11:56:51+02:00https://www.cepartner4u.com/imdrf-medical-device-health-equity/2024-02-08T11:22:55+01:00https://www.cepartner4u.com/mdcg-2024-2-rev1/2025-02-11T14:36:39+01:00https://www.cepartner4u.com/mdcg-2024-03/2024-05-07T11:41:49+02:00https://www.cepartner4u.com/ec-final-report-study-implementation-art-17-mdr-medical-devices-on-eu-market/2024-04-11T14:32:25+02:00https://www.cepartner4u.com/mdcg-2024-4/2024-04-22T17:02:03+02:00https://www.cepartner4u.com/mdcg-2022-9-rev-1/2024-04-22T17:07:33+02:00https://www.cepartner4u.com/mdcg-2024-5/2024-04-22T17:20:03+02:00https://www.cepartner4u.com/mdcg-2024-6-7-8-and-9/2025-01-14T14:50:41+01:00https://www.cepartner4u.com/mdcg-2024-10/2024-06-25T16:10:52+02:00https://www.cepartner4u.com/manufacturers-declaration-regulation-eu-2024-1860/2024-07-25T15:08:47+02:00https://www.cepartner4u.com/all-documents-related-to-the-mdr-and-ivdr-amending-regulations/2024-07-29T14:57:35+02:00https://www.cepartner4u.com/mdcg-2023-7-published/2024-09-10T14:53:37+02:00https://www.cepartner4u.com/mdcg-2019-7-rev-1-published/2024-09-10T15:18:06+02:00https://www.cepartner4u.com/effective-pms-system/2024-10-29T11:41:51+01:00https://www.cepartner4u.com/qa-article-10a-mdr-ivdr/2024-10-30T15:15:54+01:00https://www.cepartner4u.com/european-commission-issued-a-qa-on-gradual-roll-out-of-eudamed/2024-11-21T15:21:09+01:00https://www.cepartner4u.com/revision-1-mdcg-2019-13/2024-12-17T16:40:21+01:00https://www.cepartner4u.com/mdcg-issued-2024-11/2025-01-09T10:55:31+01:00https://www.cepartner4u.com/mdcg-issued-2024-13/2025-01-09T11:01:38+01:00https://www.cepartner4u.com/mdcg-2019-6-revision-5-issued-qa-on-requirements-relating-to-notified-bodies/2025-02-11T14:31:07+01:00https://www.cepartner4u.com/imdrf-medical-device-software-and-software-specific-risk/2025-05-20T13:17:10+02:00