https://www.advenaltd.eu/latest-news/ https://www.advenaltd.eu/2026/04/new-delegated-acts-under-the-mdr-introduce-targeted-relief-for-well-established-technologies/ 2026-04-02T08:52:05+01:00 https://www.advenaltd.eu/2026/04/update-notified-bodies-survey-on-certifications-and-applications-2/ 2026-04-02T08:49:43+01:00 https://www.advenaltd.eu/2026/04/update-mdcg-2025-8-rev-1-guidance-on-the-implementation-of-the-master-udi-di-solution-for-spectacle-frames-spectacle-lenses-and-ready-to-wear-reading-spectacles/ 2026-04-02T08:43:55+01:00 https://www.advenaltd.eu/2026/04/new-mir-form-template-to-become-mandatory-as-from-1st-of-may-2026/ 2026-04-02T08:42:22+01:00 https://www.advenaltd.eu/2025/12/meet-advena-at-whx-dubai-2026/ 2026-03-10T10:23:23+00:00 https://www.advenaltd.eu/2026/03/mhra-launches-a-consultation-on-indefinite-recognition-of-ce-marked-medical-devices/ 2026-03-05T09:04:27+00:00 https://www.advenaltd.eu/2026/03/team-nb-publish-position-paper-on-demonstration-of-safety-and-performance-for-combinatorial-use-of-reagent-devices-with-other-devices-or-equipment/ 2026-03-05T08:57:33+00:00 https://www.advenaltd.eu/2026/03/team-nb-publish-position-paper-on-mdr-ivdr-revision/ 2026-03-05T08:55:05+00:00 https://www.advenaltd.eu/2026/03/advena-at-whx-dubai-2026/ 2026-03-05T08:51:14+00:00 https://www.advenaltd.eu/2026/02/commission-implementing-decision-eu-2026-193/ 2026-02-02T10:25:56+00:00 https://www.advenaltd.eu/2026/01/ec-survey-for-md-ivd-manufacturers-and-ars-on-the-status-of-the-mdr-ivdr-implementation-invitation-to-participate/ 2026-01-30T09:35:30+00:00 https://www.advenaltd.eu/2026/01/new-notified-body-has-been-designated-under-the-mdr/ 2026-01-30T09:34:04+00:00 https://www.advenaltd.eu/2026/01/iso-10993-12025-biological-evaluation-of-medical-devices-part-1-requirements-and-general-principles-for-the-evaluation-of-biological-safety-within-a-risk-management-process/ 2026-01-30T09:32:42+00:00 https://www.advenaltd.eu/2026/01/advena-launches-youtube-channel/ 2026-01-30T09:29:29+00:00 https://www.advenaltd.eu/2025/12/proposal-for-a-regulation-to-simplify-rules-on-medical-and-in-vitro-diagnostic-devices/ 2025-12-23T10:04:09+00:00 https://www.advenaltd.eu/2025/12/update-to-our-email-addresses-and-website-url/ 2025-12-23T09:22:13+00:00 https://www.advenaltd.eu/2025/12/advena-srl-receives-srn-in-record-time/ 2025-12-23T09:19:32+00:00 https://www.advenaltd.eu/2025/12/advena-opens-a-new-office-in-italy/ 2025-12-23T09:17:35+00:00 https://www.advenaltd.eu/2025/12/update-mdcg-2025-7-rev-1-mdcg-position-paper-timelines-of-the-implementation-of-master-udi-di-to-contact-lenses-and-spectacle-frames-spectacle-lenses-and-ready-to-wear-reading-sp/ 2025-12-23T08:58:21+00:00 https://www.advenaltd.eu/2025/12/mdcg-2025-10-guidance-on-post-market-surveillance-of-medical-devices-and-in-vitro-diagnostic-medical-devices/ 2025-12-23T08:53:07+00:00 https://www.advenaltd.eu/2025/12/mdcg-2025-9-guidance-on-breakthrough-devices-btx-under-regulations-2017-745-2017-746/ 2025-12-23T08:51:23+00:00 https://www.advenaltd.eu/2025/12/eudamed-to-become-mandatory-as-from-28th-may-2026/ 2025-12-01T15:57:44+00:00 https://www.advenaltd.eu/2025/12/update-to-ivd-classification-guidance-to-strengthen-clarity/ 2025-12-01T14:57:10+00:00 https://www.advenaltd.eu/2025/12/who-publish-second-edition-of-development-of-medical-device-policies/ 2025-12-01T14:48:27+00:00 https://www.advenaltd.eu/2025/08/meet-advena-at-united-medical-expo-in-kazakhstan/ 2025-11-04T09:00:28+00:00 https://www.advenaltd.eu/2025/11/eudamed-training-updates-and-key-implementation-timelines/ 2025-11-04T08:57:23+00:00 https://www.advenaltd.eu/2025/11/new-notified-body-has-been-designated-under-ivdr-2/ 2025-11-04T08:53:55+00:00 https://www.advenaltd.eu/2025/11/new-notified-body-has-been-designated-under-mdr-3/ 2025-11-04T08:51:13+00:00 https://www.advenaltd.eu/2025/11/deadline-to-make-use-of-new-mir-template-has-been-delayed/ 2025-11-04T08:49:30+00:00 https://www.advenaltd.eu/2025/11/advena-at-united-medical-expo-in-kazakhstan/ 2025-11-04T08:47:21+00:00 https://www.advenaltd.eu/2025/11/commission-implementing-decision-eu-2025-2078/ 2025-11-04T08:44:36+00:00 https://www.advenaltd.eu/2025/09/update-team-nb-update-position-paper-regarding-technical-documentation-under-ivdr/ 2025-09-30T15:39:42+01:00 https://www.advenaltd.eu/2025/09/mdcg-releases-draft-guidance-on-trend-reporting/ 2025-09-30T15:38:16+01:00 https://www.advenaltd.eu/2025/09/update-manual-on-borderline-and-classification/ 2025-09-30T15:36:57+01:00 https://www.advenaltd.eu/2025/09/medical-devices-and-in-vitro-diagnostics-targeted-revision-of-eu-rules/ 2025-09-30T15:35:43+01:00 https://www.advenaltd.eu/2025/08/medtech-europe-proposal-for-a-more-risk-based-approach-for-sampling-under-the-ivdr/ 2025-08-29T12:32:19+01:00 https://www.advenaltd.eu/2025/08/update-mdcg-2024-14-rev-1-guidance-on-the-implementation-of-the-master-udi-di-solution-for-contact-lenses/ 2025-08-29T12:30:07+01:00 https://www.advenaltd.eu/2025/08/update-mdr-language-requirements/ 2025-08-29T12:27:25+01:00 https://www.advenaltd.eu/2025/08/important-announcement-concerning-eu-device-registrations/ 2025-08-29T12:23:29+01:00 https://www.advenaltd.eu/2025/08/advena-pass-re-certification-audit/ 2025-08-25T14:16:43+01:00 https://www.advenaltd.eu/2025/08/we-are-recruiting-3/ 2025-08-13T14:52:48+01:00 https://www.advenaltd.eu/2025/08/2025-788-commission-delegated-regulation-eu-2025-788-of-16-april-2025-amending-delegated-regulation-eu-2023-2197-as-regards-the-date-of-application/ 2025-08-01T09:41:29+01:00 https://www.advenaltd.eu/2025/08/mdcg-2025-7-mdcg-position-paper-timelines-of-the-implementation-of-master-udi-di-to-contact-lenses-and-spectacle-frames-spectacle-lenses-and-ready-to-wear-reading-spectacles/ 2025-08-01T09:38:33+01:00 https://www.advenaltd.eu/2025/08/updated-eudamed-timeline-has-been-published/ 2025-08-01T09:02:13+01:00 https://www.advenaltd.eu/2025/08/new-notified-body-has-been-designated-under-the-ivdr-2/ 2025-08-01T08:58:01+01:00 https://www.advenaltd.eu/2025/08/advena-at-whx-kuala-lumpur/ 2025-08-01T08:50:15+01:00 https://www.advenaltd.eu/2025/06/meet-advena-at-whx-kuala-lumpur/ 2025-07-21T14:35:32+01:00 https://www.advenaltd.eu/2025/06/aib-2025-1-mdcg-2025-6-interplay-between-the-medical-devices-regulation-mdr-in-vitro-diagnostic-medical-devices-regulation-ivdr-and-the-artificial-intelligence-act-aia/ 2025-06-27T08:04:43+01:00 https://www.advenaltd.eu/2025/06/update-mdcg-2019-11-rev-1-guidance-on-qualification-and-classification-of-software-in-regulation-eu-2017-745-mdr-and-regulation-eu-2017-746-ivdr/ 2025-06-27T08:03:14+01:00 https://www.advenaltd.eu/2025/06/mdcg-2025-5-questions-answers-regarding-performance-studies-of-in-vitro-diagnostic-medical-devices-under-regulation-eu-2017-746/ 2025-06-27T08:01:57+01:00 https://www.advenaltd.eu/2025/06/mdcg-2025-4-guidance-on-the-safe-making-available-of-medical-device-software-mdsw-apps-on-online-platforms/ 2025-06-27T08:00:21+01:00 https://www.advenaltd.eu/2025/06/emdn-helpdesk-is-now-active/ 2025-06-02T11:24:09+01:00 https://www.advenaltd.eu/2025/06/update-notified-bodies-survey-on-certifications-and-applications/ 2025-06-02T11:18:33+01:00 https://www.advenaltd.eu/2025/06/eu-commission-release-new-mir-template/ 2025-06-02T10:18:04+01:00 https://www.advenaltd.eu/2025/06/new-notified-body-has-been-designated-under-ivdr/ 2025-06-02T09:54:55+01:00 https://www.advenaltd.eu/2025/06/advena-at-hospitalar-brazil/ 2025-06-02T08:41:47+01:00 https://www.advenaltd.eu/2025/04/meet-advena-at-hospitalar-brazil/ 2025-05-27T08:46:24+01:00 https://www.advenaltd.eu/2025/04/important-dates-for-manufacturers/ 2025-04-30T10:55:44+01:00 https://www.advenaltd.eu/2025/04/deadline-of-udi-carrier-on-labelling-of-class-i-class-a-devices-has-arrived/ 2025-04-30T10:41:43+01:00 https://www.advenaltd.eu/2025/04/important-deadline-for-class-d-ivd-manufacturers/ 2025-04-30T10:23:13+01:00 https://www.advenaltd.eu/2025/04/eu-commission-to-organise-hybrid-workshop-to-support-eudamed-onboarding/ 2025-04-30T08:43:43+01:00 https://www.advenaltd.eu/2025/04/eu-publish-ai-continent-action-plan/ 2025-04-30T08:40:24+01:00 https://www.advenaltd.eu/2025/04/commission-implementing-decision-eu-2025-679-of-8-april-2025-amending-implementing-decision-eu-2021-1195-as-regards-harmonised-standards-for-sterilization-of-medical-devices/ 2025-04-30T08:38:37+01:00 https://www.advenaltd.eu/2025/04/three-new-notified-bodies-have-been-designated-under-ivdr/ 2025-04-30T08:35:47+01:00 https://www.advenaltd.eu/2025/04/update-new-uk-approved-body/ 2025-04-30T08:32:31+01:00 https://www.advenaltd.eu/2025/04/medtech-europe-issue-decision-making-flowchart-regarding-article-10a-mdr-ivdr/ 2025-04-01T09:30:07+01:00 https://www.advenaltd.eu/2025/04/various-european-organisations-publish-joint-discussion-paper-on-the-future-governance-of-medical-technologies-in-europe/ 2025-04-01T09:28:19+01:00 https://www.advenaltd.eu/2025/04/medtech-europe-issue-position-paper-on-submission-of-vigilance-reports-to-notified-bodies-under-eu-mdr-ivdr/ 2025-04-01T09:24:31+01:00 https://www.advenaltd.eu/2025/04/update-iso-15223-12021/ 2025-04-01T09:15:29+01:00 https://www.advenaltd.eu/2025/04/update-mdcg-2020-16-rev-4-guidance-on-classification-rules-for-in-vitro-diagnostic-medical-devices-under-regulation-eu-2017-746/ 2025-04-01T09:12:09+01:00 https://www.advenaltd.eu/2025/04/advena-at-medical-fair-india-2/ 2025-04-01T09:07:48+01:00 https://www.advenaltd.eu/2025/02/meet-advena-at-medical-fair-india/ 2025-04-01T08:45:39+01:00 https://www.advenaltd.eu/2025/02/eu-commission-has-released-draft-regulation-regarding-udi-assignment-for-certain-medical-devices/ 2025-02-28T14:37:56+00:00 https://www.advenaltd.eu/2025/02/eu-publishes-guidance-on-ai-act/ 2025-02-28T14:13:36+00:00 https://www.advenaltd.eu/2025/02/updated-mdcg-2019-6-rev5-questions-and-answers-requirements-relating-to-notified-bodies/ 2025-02-28T14:07:47+00:00 https://www.advenaltd.eu/2025/02/advena-in-dubai/ 2025-02-28T13:50:19+00:00 https://www.advenaltd.eu/2024/11/meet-advena-in-dubai/ 2025-02-11T12:53:18+00:00 https://www.advenaltd.eu/2025/02/latest-consolidated-version-of-ivdr-published/ 2025-02-03T19:26:21+00:00 https://www.advenaltd.eu/2025/02/update-mdcg-2023-3-rev-2-questions-and-answers-on-vigilance-terms-and-concepts-as-outlined-in-the-regulation-eu-2017-745-and-regulation-eu-2017-746/ 2025-02-03T19:10:23+00:00 https://www.advenaltd.eu/2025/02/advena-at-arab-health-2025/ 2025-02-03T19:00:25+00:00 https://www.advenaltd.eu/2025/02/update-uk-approved-bodies/ 2025-02-03T18:54:33+00:00 https://www.advenaltd.eu/2025/02/mhra-release-new-guidance-on-post-market-surveillance/ 2025-02-03T18:52:08+00:00 https://www.advenaltd.eu/2024/12/commission-launches-a-public-consultation-and-a-call-for-evidence-for-eu-medical-devices-evaluation/ 2024-12-19T10:15:31+00:00 https://www.advenaltd.eu/2024/12/mdcg-2024-16-manufacturer-information-form-on-interruption-or-discontinuation-of-supply-of-certain-medical-devices-and-certain-in-vitro-diagnostic-medical-devices/ 2024-12-19T10:10:00+00:00 https://www.advenaltd.eu/2024/12/mhra-publish-revised-roadmap-for-implementation-of-medical-devices-future-regime/ 2024-12-19T10:05:23+00:00 https://www.advenaltd.eu/2024/12/mhra-trials-five-innovative-ai-technologies-as-part-of-pilot-scheme-to-change-regulatory-approach/ 2024-12-19T09:53:46+00:00 https://www.advenaltd.eu/2024/12/new-consolidated-version-of-the-mdr-released-in-html-format/ 2024-12-19T09:45:57+00:00 https://www.advenaltd.eu/2024/12/christmas-new-year-shutdown-period/ 2024-12-19T09:42:56+00:00 https://www.advenaltd.eu/2024/12/new-malta-medicines-authoritys-email-address-for-vigilance/ 2024-12-19T09:39:55+00:00 https://www.advenaltd.eu/2024/12/mdcg-2024-15-guidance-on-the-publication-of-the-clinical-investigation-reports-and-their-summaries-in-the-absence-of-eudamed/ 2024-12-19T09:37:04+00:00 https://www.advenaltd.eu/2024/11/mhra-publish-new-consultation-regarding-routes-to-market-and-in-vitro-diagnostic-devices/ 2024-11-28T10:09:32+00:00 https://www.advenaltd.eu/2024/11/update-mdcg-2023-3-rev-1-questions-and-answers-on-vigilance-terms-and-concepts-as-outlined-in-the-regulation-eu-2017-745-and-regulation-eu-2017-746/ 2024-11-27T12:46:18+00:00 https://www.advenaltd.eu/2024/11/mdcg-2024-14-guidance-on-the-implementation-of-the-master-udi-di-solution-for-contact-lenses/ 2024-11-27T12:17:26+00:00 https://www.advenaltd.eu/2024/11/eu-commission-release-qa-regarding-gradual-rollout-of-eudamed/ 2024-11-27T12:03:57+00:00 https://www.advenaltd.eu/2024/11/advena-at-medica-2024/ 2024-11-27T11:35:19+00:00 https://www.advenaltd.eu/2024/08/meet-advena-at-medica-2024/ 2024-11-18T09:09:13+00:00 https://www.advenaltd.eu/2024/10/qa-published-by-the-eu-commission-regarding-information-obligation-in-case-of-interruption-or-discontinuation-of-supply-of-certain-medical-devices-or-in-vitro-diagnostic-devices/ 2024-10-30T15:52:26+00:00 https://www.advenaltd.eu/2024/10/mdcg-2024-13-regulatory-status-of-ethylene-oxide-eto-intended-for-the-sterilisation-of-medical-devices/ 2024-10-30T09:57:39+00:00 https://www.advenaltd.eu/2024/10/update-mdcg-2022-5-rev-1-guidance-on-borderline-between-medical-devices-and-medicinal-products-under-regulation-eu-2017-745-on-medical-devices/ 2024-10-30T09:56:05+00:00 https://www.advenaltd.eu/2024/10/eu-parliament-vote-to-revise-mdr-and-ivdr/ 2024-10-30T09:51:17+00:00 https://www.advenaltd.eu/2024/10/eu-publishes-new-harmonised-standards-for-mdr-and-ivdr/ 2024-10-29T10:15:38+00:00 https://www.advenaltd.eu/2024/10/mdcg-2024-11-guidance-on-qualification-of-in-vitro-diagnostic-medical-devices/ 2024-10-24T15:39:44+01:00 https://www.advenaltd.eu/2024/10/mhra-submit-draft-post-market-surveillance-statutory-instrument-to-parliament/ 2024-10-24T15:37:17+01:00 https://www.advenaltd.eu/2024/10/update-mdcg-2021-25-rev-1-regulation-eu-2017-745-application-of-mdr-requirements-to-legacy-devices-and-to-devices-placed-on-the-market-prior-to-26-may-2021-in-accordance-with-d/ 2024-10-23T16:04:59+01:00 https://www.advenaltd.eu/2024/10/mdcg-2024-12-corrective-and-preventive-action-capa-plan-assessment-guidance-and-templates-for-conformity-assessment-bodies-notified-bodies-designating-authorities-and-joint-assessment-teams/ 2024-10-23T15:48:49+01:00 https://www.advenaltd.eu/2024/10/new-notified-body-has-been-designated-under-mdr-2/ 2024-10-23T15:40:43+01:00 https://www.advenaltd.eu/2024/10/advena-malta-passes-iso-13485-surveillance-audit/ 2024-10-15T15:14:23+01:00 https://www.advenaltd.eu/2023/05/regulation-eu-2023-607-meeting-the-obligations-of-the-amended-transitional-provisions/ 2024-10-02T07:53:42+01:00 https://www.advenaltd.eu/2024/09/current-state-of-play-for-medical-devices-mdr-ivdr/ 2024-09-30T15:15:18+01:00 https://www.advenaltd.eu/2024/09/update-mdcg-2021-4-rev-1-application-of-transitional-provisions-for-certification-of-class-d-in-vitro-diagnostic-medical-devices-according-to-regulation-eu-2017-746/ 2024-09-27T09:38:41+01:00 https://www.advenaltd.eu/2024/09/team-nb-publish-position-paper-regarding-the-transfer-agreement-for-the-surveillance-of-legacy-devices-for-ivds/ 2024-09-27T09:16:50+01:00 https://www.advenaltd.eu/2024/09/new-notified-body-has-been-designated-under-the-ivdr/ 2024-09-27T09:14:30+01:00 https://www.advenaltd.eu/2024/09/advena-wins-regulatory-consultancy-award/ 2024-09-02T13:38:17+01:00 https://www.advenaltd.eu/2024/09/new-service-announcement-ar-services-for-machinery-and-general-product-safety-regulation-and-toy-directive/ 2024-09-02T13:26:36+01:00 https://www.advenaltd.eu/2024/09/advena-at-medi-pharm-expo-in-vietnam/ 2024-09-02T10:58:23+01:00 https://www.advenaltd.eu/2024/09/eu-commission-release-list-of-notified-bodies-with-their-published-fees/ 2024-09-02T10:19:25+01:00 https://www.advenaltd.eu/2024/09/commission-implementing-decision-eu-2024-2120-of-30-july-2024-renewing-the-designation-of-issuing-entities-designated-to-operate-a-system-for-the-assignment-of-unique-device-identifiers-udis-in-th/ 2024-09-02T10:14:01+01:00 https://www.advenaltd.eu/2024/06/meet-advena-at-medi-pharm-expo-in-vietnam/ 2024-08-05T13:47:26+01:00 https://www.advenaltd.eu/2024/07/ai-act-has-been-published-in-the-ojeu/ 2024-07-25T14:40:25+01:00 https://www.advenaltd.eu/2024/07/regulation-eu-2024-1860-published-in-official-journal-of-the-european-union-ojeu/ 2024-07-25T14:35:09+01:00 https://www.advenaltd.eu/2024/07/update-mdcg-2021-5-rev-1-guidance-on-standardisation-for-medical-device/ 2024-07-25T14:16:26+01:00 https://www.advenaltd.eu/2024/07/self-declaration-template-has-been-published-by-the-med-tech/ 2024-07-25T14:05:45+01:00 https://www.advenaltd.eu/2024/07/qa-on-the-extension-of-the-ivdr-transitional-peroids-has-been-released/ 2024-07-18T13:57:12+01:00 https://www.advenaltd.eu/2024/07/update-mdcg-2020-16-rev-3-guidance-on-classification-rules-for-in-vitro-diagnostic-medical-devices-under-regulation-eu-2017-746/ 2024-07-18T13:21:40+01:00 https://www.advenaltd.eu/2024/07/advena-at-asia-health-2024/ 2024-07-18T12:43:45+01:00 https://www.advenaltd.eu/2024/07/gradual-rollout-of-eudamed-roadmap-published/ 2024-07-18T12:20:36+01:00 https://www.advenaltd.eu/2024/06/meet-advena-at-asia-health-2024/ 2024-07-15T07:20:00+01:00 https://www.advenaltd.eu/2024/06/mdcg-2024-10-clinical-evaluation-of-orphan-medical-devices/ 2024-06-28T13:12:07+01:00 https://www.advenaltd.eu/2024/06/mdcg-2024-1-5-guidance-on-the-vigilance-system-for-ce-marked-devices-dsvg-05-urogynaecological-surgical-mesh-implants-used-for-pelvic-organ-prolapse-repair-and-stress-urinary-incontinence/ 2024-06-28T13:09:45+01:00 https://www.advenaltd.eu/2024/06/are-you-considering-selling-your-medical-devices-ivd-devices-in-the-european-union/ 2024-06-06T15:57:00+01:00 https://www.advenaltd.eu/2024/06/auditing-of-authorized-representatives/ 2024-06-03T16:50:19+01:00 https://www.advenaltd.eu/2024/06/update-eu-council-adopt-proposal-put-forward-by-the-eu-commission/ 2024-06-03T16:49:26+01:00 https://www.advenaltd.eu/2024/06/eu-council-approves-ai-act/ 2024-06-03T10:21:18+01:00 https://www.advenaltd.eu/2024/06/mdcg-release-preliminary-re-assessment-review-form-templates-for-mdr-and-ivdr/ 2024-06-03T10:18:02+01:00 https://www.advenaltd.eu/2024/06/update-mdcg-2022-4-rev-2-guidance-on-appropriate-surveillance-regarding-the-transitional-provisions-under-article-120-of-the-mdr-with-regard-to-devices-covered-by-certificates-according-to-the-mdd-or/ 2024-06-03T10:07:22+01:00 https://www.advenaltd.eu/2024/06/advena-at-hospitalar-2024/ 2024-06-03T09:27:30+01:00 https://www.advenaltd.eu/2024/06/mhra-proposes-recognition-path-for-devices-cleared-by-trusted-regulators/ 2024-06-03T09:17:49+01:00 https://www.advenaltd.eu/2024/06/three-new-notified-bodies-have-been-designated-for-mdr/ 2024-06-03T09:00:52+01:00 https://www.advenaltd.eu/2024/04/meet-advena-at-hospitalar-2024/ 2024-05-28T07:44:50+01:00 https://www.advenaltd.eu/2024/04/eu-parliament-adopts-the-proposal-put-forward-by-the-eu-commission-regarding-the-gradual-roll-out-of-eudamed/ 2024-04-30T14:24:38+01:00 https://www.advenaltd.eu/2024/04/eu-parliament-adopts-the-proposal-put-forward-by-the-eu-commission-regarding-the-extension-in-the-transition-periods-for-certain-ivds/ 2024-04-30T14:21:55+01:00 https://www.advenaltd.eu/2024/04/eu-commission-release-report-from-study-conducted-regarding-the-implementation-of-article-17-of-regulation-eu-2017-745-on-medical-devices-on-the-eu-market/ 2024-04-29T13:22:01+01:00 https://www.advenaltd.eu/2024/04/mdcg-2024-5-guidance-on-content-of-the-investigators-brochure-for-clinical-investigations-of-medical-devices/ 2024-04-29T13:18:58+01:00 https://www.advenaltd.eu/2024/04/mdcg-2024-4-safety-reporting-in-performance-studies-of-in-vitro-diagnostic-medical-devices-under-regulation-eu-2017-746/ 2024-04-29T13:15:57+01:00 https://www.advenaltd.eu/2024/04/new-notified-body-has-been-designated-for-mdr-2/ 2024-04-29T08:43:01+01:00 https://www.advenaltd.eu/2024/02/we-are-recruiting-2/ 2024-04-10T15:30:09+01:00 https://www.advenaltd.eu/2024/03/new-mdcg-guidance-issued-concerning-the-clinical-investigation-plan-for-clinical-investigations-of-medical-devices/ 2024-03-28T08:19:20+00:00 https://www.advenaltd.eu/2024/03/advena-at-medical-fair-india/ 2024-03-28T08:11:27+00:00 https://www.advenaltd.eu/2024/03/mhra-webinar-provides-updates-on-the-state-of-uk-medical-device-regulatory-reform/ 2024-03-28T08:02:42+00:00 https://www.advenaltd.eu/2024/03/new-notified-body-has-been-designated-for-mdr/ 2024-03-26T09:23:02+00:00 https://www.advenaltd.eu/2024/01/meet-advena-at-medical-fair-india-in-mumbai/ 2024-03-18T16:12:48+00:00 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https://www.advenaltd.eu/2024/01/eu-commission-proposes-ivdr-extension/ 2024-01-24T15:03:38+00:00 https://www.advenaltd.eu/2024/01/eu-commission-proposes-gradual-eudamed-rollout/ 2024-01-24T11:18:04+00:00 https://www.advenaltd.eu/2024/01/the-european-commissions-directorate-general-for-health-and-food-safety-has-published-mdr-and-ivdr-language-requirements-for-manufacturers/ 2024-01-18T14:50:33+00:00 https://www.advenaltd.eu/2024/01/mhra-publishes-new-roadmap-concerning-the-future-regulatory-framework-for-medical-devices/ 2024-01-12T16:29:15+00:00 https://www.advenaltd.eu/2023/11/mdr-and-ivdr-communication-survey/ 2024-01-08T10:33:15+00:00 https://www.advenaltd.eu/2023/12/the-eu-commission-has-commissioned-a-study-monitoring-the-availability-of-medical-devices-on-the-eu-market/ 2024-01-08T10:32:37+00:00 https://www.advenaltd.eu/2023/12/eu-commission-release-information-on-the-applications-for-designation-as-a-notified-body/ 2024-01-08T10:31:33+00:00 https://www.advenaltd.eu/2013/10/8-reasons-why-you-should-implement-a-quality-management-system/ 2024-01-02T13:19:02+00:00 https://www.advenaltd.eu/2013/11/electrical-safety-testing/ 2024-01-02T13:16:39+00:00 https://www.advenaltd.eu/2013/11/web-based-quality-management-system-activ/ 2024-01-02T13:15:36+00:00 https://www.advenaltd.eu/2013/11/major-changes-to-audits-and-quality-management-systems-qms/ 2024-01-02T13:14:42+00:00 https://www.advenaltd.eu/2015/07/advena-acquires-medical-device-qa-services-ltd/ 2024-01-02T13:13:42+00:00 https://www.advenaltd.eu/2015/11/meet-advena-at-medica-2015/ 2024-01-02T13:13:05+00:00 https://www.advenaltd.eu/2016/09/meet-advena-at-medica-2016/ 2024-01-02T13:12:29+00:00 https://www.advenaltd.eu/2013/11/priority-actions-for-manufacturers/ 2024-01-02T13:12:03+00:00 https://www.advenaltd.eu/2013/11/new-qms-activ-hr-management-module/ 2024-01-02T13:11:21+00:00 https://www.advenaltd.eu/2013/12/notified-body-unannounced-audits/ 2024-01-02T13:09:31+00:00 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https://www.advenaltd.eu/2023/11/advena-at-medica-2023/ 2023-11-24T16:23:28+00:00 https://www.advenaltd.eu/2023/08/meet-advena-at-medica-2023/ 2023-11-20T09:47:32+00:00 https://www.advenaltd.eu/2023/10/new-notified-body-designated-for-ivdr-2/ 2023-10-31T09:12:41+00:00 https://www.advenaltd.eu/2023/10/mandatory-implementation-of-eudamed-delayed-once-again/ 2023-10-31T08:49:10+00:00 https://www.advenaltd.eu/2023/10/mdcg-2023-4-medical-device-software-mdsw-hardware-combinations-guidance-on-mdsw-intended-to-work-in-combination-with-hardware-or-hardware-components/ 2023-10-25T12:15:50+01:00 https://www.advenaltd.eu/2023/10/prominent-european-associations-urge-a-re-think-to-the-revision-of-the-pld/ 2023-10-25T12:11:47+01:00 https://www.advenaltd.eu/2023/10/european-commission-decides-to-ease-udi-requirements-for-contact-lenses/ 2023-10-25T12:08:39+01:00 https://www.advenaltd.eu/2023/10/leveraging-your-ce-mark-with-a-certificate-of-free-sale/ 2023-10-24T07:36:32+01:00 https://www.advenaltd.eu/2023/08/meet-advena-at-med-tech-world-2023/ 2023-10-23T10:16:27+01:00 https://www.advenaltd.eu/2023/09/qa-published-on-transitional-provisions-for-products-without-an-intended-medical-purpose-covered-by-annex-xvi-of-the-mdr/ 2023-09-29T13:35:55+01:00 https://www.advenaltd.eu/2023/09/advena-nominated-for-best-consultancy-services-in-med-tech-for-2023/ 2023-09-29T10:09:05+01:00 https://www.advenaltd.eu/2023/09/new-notified-body-designated-for-ivdr/ 2023-09-29T10:07:59+01:00 https://www.advenaltd.eu/2023/09/update-to-manual-on-borderline-and-classification-for-medical-devices-under-regulation-eu-2017-745-on-medical-devices-and-regulation-eu-2017-746-on-in-vitro-diagnostic-medical-devices/ 2023-09-28T15:03:25+01:00 https://www.advenaltd.eu/2023/09/medtech-europe-sends-open-letter-to-eu-commissioner-for-health-stella-kyriakides/ 2023-09-28T13:50:37+01:00 https://www.advenaltd.eu/2023/04/advena-services-limited-obtains-iso-134852016-certificate/ 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https://www.advenaltd.eu/2016/06/eu-medical-device-rgulations-public-liability/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2016/06/uk-membership-of-the-eu/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2016/09/expomedical-2016-argentina/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2016/09/prepared-for-brexit-advena-in-the-news/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2016/10/client-satisfaction-survey-2016-results/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2017/01/lithium-batteries-and-medical-devices-in-the-eu/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2017/01/reusable-surgical-instruments/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2017/02/medical-device-regulation-reprocessing-of-single-use-devices/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2017/03/medical-device-regulation-technical-file-requirements/ 2023-08-31T18:08:03+01:00 https://www.advenaltd.eu/2017/04/virtual-manufacturing-replaces-obl/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2017/04/in-vitro-diagnostic-medical-device-regulation/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2017/05/breaking-news-the-new-regulation-on-medical-devices-mdr-and-regulation-on-in-vitro-diagnostic-medical-devices-ivdr-are-now-published/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2017/08/product-liability-insurance-mdr-ivdr/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2017/08/fantastic-employment-opportunity-at-advena/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2017/08/avoid-this-major-non-conformity/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2017/09/intended-use-vs-indications-for-use/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2017/10/an-exciting-career-opportunity-with-advena-limited/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2017/10/due-to-continued-growth-advena-are-seeking-to-employ-another-senior-regulatory-consultant/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2018/02/breaking-news-intertek-amtac/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2018/02/brexit-and-the-uk-medical-device-industry/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2018/02/using-distributors-and-importers-as-an-ec-rep-and-data-security/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2018/02/another-advena-success/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2018/06/eu-authorised-representative-ec-rep-unannounced-audits/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2018/06/brexit-and-access-to-the-eu-market-for-medical-devices/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2018/11/brexit-and-uk-medical-device-manufacturers-access-to-the-eu-market/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2019/07/udi-issuing-entities/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2019/08/an-exciting-career-opportunity-with-advena-limited-in-malta/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2019/11/an-exciting-career-opportunity-with-advena-limited-in-the-uk/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2020/03/unique-device-identification-udi-system-eu2017-745-eu2017-746/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2020/03/advena-limited-eu-authorised-representative-ec-rep-qms-regulatory-consultancy-services-statement-on-covid-19/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2020/04/mdr-article-1203-terms-and-conditions/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2020/08/an-exciting-career-opportunity-with-advena-limited-in-malta-2/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2020/08/covid-19-protective-equipment/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2020/08/ukca-uks-proposed-ce-mark-replacement/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2021/02/the-deadline-for-the-mdr-transition-is-fast-approaching-are-you-prepared/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2021/02/quality-management-systems-qms-under-the-mdr/ 2023-08-31T18:08:02+01:00 https://www.advenaltd.eu/2021/06/due-to-continued-growth-advena-limited-in-malta-are-looking-for-a-regulatory-intern/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2021/09/mdr-article-120-transitional-provisions/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2021/10/en-iso-134852016-amendment/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2021/10/proposed-ivdr-transitional-provisions-amendment/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/06/advena-ltd-malta-gains-iso134852016-certification/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/06/eu-ivdr-application-date/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/06/mdcg-2022-6-legacy-ivd-significant-change/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/06/mdcg-2022-7-udi-system-qa/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/06/mdcg-2022-8-application-of-ivdr-to-legacy-devices/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/06/mdcg-2022-9-summary-of-safety-and-performance-template/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/07/eu-blue-guide-update/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/07/mdcg-2022-11/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/07/eu-reference-laboratories/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/07/ivd-common-specifications-class-d/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/08/ivdr-common-specifications/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/08/exhibition-news-med-tech-world-arab-health/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/08/career-opportunities-with-advena-in-malta/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/09/eu-commission-draft-implementing-regulation/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/10/mdcg-guidance-mdcg-2021-22-rev-1/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/10/manual-on-borderline-and-classification-under-regulations-eu-2017-745-and-2017-746/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/10/advena-is-taking-part-in-med-tech-world-in-malta/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/11/mdcg-guidance-on-eu-authorised-representatives-released-mdcg-2022-16/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/11/advena-awarded-best-medical-device-regulatory-consultancy-2022/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/11/mhra-announce-a-12-month-extension-to-uk-medical-device-regulations/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/11/regulatory-consultancy-technical-file-creation-gap-analysis-reviews-updates/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/11/advena-launches-a-new-group-company/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/11/mdr-ivdr-article-13-regulatory-importer-service/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2022/12/advena-awarded-the-best-med-tech-consultancy-2022/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/01/mdcg-2022-18-position-paper-article-97-of-the-mdr/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/01/meet-advena-at-arab-health-2023/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/03/eu-parliament-votes-in-favour-of-commissions-proposal-regarding-the-extension-of-mdr-timelines/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/03/notified-body-response-times-and-availability/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/03/mdr-extension-amendment-comes-into-force/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/03/qa-on-the-practical-aspects-related-to-the-implementation-of-regulation-eu-2023-607-amending-regulations-eu-2017-745-and-eu-2017-746/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/06/update-on-guidance-mdcg-2020-3-rev-1/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/08/update-of-the-qa-document-on-the-extension-of-the-mdr-transitional-period/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/08/eu-commission-release-harmonised-manufacturer-self-declaration-template/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/08/flowchart-issued-relating-to-the-applicability-of-the-extension-in-transitional-periods-as-detailed-in-eu-2023-607/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/08/three-new-uk-approved-bodies-announced-by-the-mhra/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/08/team-notified-body-issues-a-position-paper-regarding-the-new-mdr-transition-timelines-notified-body-capacity/ 2023-08-31T18:08:01+01:00 https://www.advenaltd.eu/2023/08/team-notified-body-issues-a-position-paper-regarding-the-transfer-agreement-for-the-surveillance-of-legacy-devices/ 2023-08-31T18:08:01+01:00