CSDmed https://www.csdmed.mc en Copyright 2026, CSDmed https://www.csdmed.mc/images/logo.svg CSDmed https://www.csdmed.mc Custom RSS Generator by Colibri <![CDATA[MDCG 2021-24 Guidance on classification of medical devices - October 2021]]>
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness, local vs. systemic effect, potential toxicity, the part of the body affected by the use of the device and if the device depends on a source of energy. The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:2012 ]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2021-24-guidance-on-classification-of-medical-devices-56 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2021-24-guidance-on-classification-of-medical-devices-56 Fri, 07 Jan 2022 00:00:00 +0100 <![CDATA[MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation - December 2021]]>
December 9, 2021, new guidance document was released by the Medical Device Coordination Group (MDCG). This new document provide guidance with regards to substantial modifications of clinical investigation under Medical Device Regulation (MDCG 2021-28). ]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2021-28-substantial-modification-of-clinical-investigation-under-medical-device-regulation-57 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2021-28-substantial-modification-of-clinical-investigation-under-medical-device-regulation-57 Thu, 13 Jan 2022 00:00:00 +0100 <![CDATA[MDCG 2022-16 Guidance on Authorised Representatives under MDR and IVDR]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2022-16-guidance-on-authorised-representatives-under-mdr-ivdr-58 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2022-16-guidance-on-authorised-representatives-under-mdr-ivdr-58 Tue, 01 Nov 2022 00:00:00 +0100 <![CDATA[Extension of transitional period of Medical Device Regulation (MDR 2017/745)]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/extension-of-transitional-period-of-medical-device-regulation-mdr-2017-745-59 https://www.csdmed.mc/en/news/medical-devices-regulation/extension-of-transitional-period-of-medical-device-regulation-mdr-2017-745-59 Mon, 12 Dec 2022 00:00:00 +0100 <![CDATA[MDCG 2023-1 - Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2023-1-guidance-on-the-health-institution-exemption-under-article-5-5-of-regulation-eu-2017-745-and-regulation-eu-2017-746-60 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2023-1-guidance-on-the-health-institution-exemption-under-article-5-5-of-regulation-eu-2017-745-and-regulation-eu-2017-746-60 Tue, 10 Jan 2023 00:00:00 +0100 <![CDATA[Come, find and meet us during the 11th edition of "la rentrée du DM" at the Kursaal of Besançon.]]>
]]> https://www.csdmed.mc/en/news/news/come-find-and-meet-us-during-the-11th-edition-of-the-la-rentree-du-dm-at-the-kursaal-of-besancon-61 https://www.csdmed.mc/en/news/news/come-find-and-meet-us-during-the-11th-edition-of-the-la-rentree-du-dm-at-the-kursaal-of-besancon-61 Tue, 20 Jun 2023 00:00:00 +0200 <![CDATA[Exciting News! CSDmed is Now a Member of the AFNOR Adherents Club]]>
]]> https://www.csdmed.mc/en/news/news/exciting-news-csdmed-is-now-a-member-of-the-afnor-adherents-club-62 https://www.csdmed.mc/en/news/news/exciting-news-csdmed-is-now-a-member-of-the-afnor-adherents-club-62 Tue, 11 Jul 2023 00:00:00 +0200 <![CDATA[MDR 2017/745 consolidated with regulations 2023-607 and 2020-561]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdr-2017-745-consolidated-with-regulations-2023-607-and-2020-561-63 https://www.csdmed.mc/en/news/medical-devices-regulation/mdr-2017-745-consolidated-with-regulations-2023-607-and-2020-561-63 Mon, 27 Mar 2023 00:00:00 +0200 <![CDATA[The hidden risks of sourcing medical equipment from China]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/the-hidden-risks-of-sourcing-medical-equipment-from-china-64 https://www.csdmed.mc/en/news/medical-devices-regulation/the-hidden-risks-of-sourcing-medical-equipment-from-china-64 Tue, 25 Jul 2023 00:00:00 +0200 <![CDATA[Understanding the Imperative of Risk Management Plan (RMP) in Medical Devices]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/understanding-the-imperative-of-risk-management-plan-rmp-in-medical-devices-65 https://www.csdmed.mc/en/news/medical-devices-regulation/understanding-the-imperative-of-risk-management-plan-rmp-in-medical-devices-65 Mon, 04 Sep 2023 00:00:00 +0200 <![CDATA[New issue of the FDA Guidance :  Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/new-issue-of-the-fda-guidance-use-of-international-standard-iso-10993-1-biological-evaluation-of-medical-devices-part-1-evaluation-and-testing-within-a-risk-management-process-66 https://www.csdmed.mc/en/news/medical-devices-regulation/new-issue-of-the-fda-guidance-use-of-international-standard-iso-10993-1-biological-evaluation-of-medical-devices-part-1-evaluation-and-testing-within-a-risk-management-process-66 Fri, 15 Sep 2023 00:00:00 +0200 <![CDATA[What is a medical device ?]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/what-is-a-medical-device-67 https://www.csdmed.mc/en/news/medical-devices-regulation/what-is-a-medical-device-67 Thu, 21 Sep 2023 00:00:00 +0200 <![CDATA[New manual on borderline and classification for medical devices]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/new-manual-on-borderline-and-classification-for-medical-devices-68 https://www.csdmed.mc/en/news/medical-devices-regulation/new-manual-on-borderline-and-classification-for-medical-devices-68 Mon, 02 Oct 2023 00:00:00 +0200 <![CDATA[Medical devices classification]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/medical-devices-classification-69 https://www.csdmed.mc/en/news/medical-devices-regulation/medical-devices-classification-69 Fri, 13 Oct 2023 00:00:00 +0200 <![CDATA[New MDCG 2023-4 guidance: Medical Device Software (MDSW) - Hardware combinations]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2023-4-software-hardware-combinations-70 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2023-4-software-hardware-combinations-70 Thu, 19 Oct 2023 00:00:00 +0200 <![CDATA[New amending document for EU MDR 2017/745: the EU 2023/2197]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/new-amending-document-2023-2197-71 https://www.csdmed.mc/en/news/medical-devices-regulation/new-amending-document-2023-2197-71 Fri, 20 Oct 2023 00:00:00 +0200 <![CDATA[Guidance on machine learning-enabled medical devices (MLMD)]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/guidance-machine-learning-enabled-medical-devices-72 https://www.csdmed.mc/en/news/medical-devices-regulation/guidance-machine-learning-enabled-medical-devices-72 Fri, 27 Oct 2023 00:00:00 +0200 <![CDATA[The calendar according to amending regulation 2023/607]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/calendar-amending-regulation-2023-607-73 https://www.csdmed.mc/en/news/medical-devices-regulation/calendar-amending-regulation-2023-607-73 Wed, 01 Nov 2023 00:00:00 +0100 <![CDATA[Implementing Regulation (EU) 2022/2346 and (EU) 2023/1194 of the arrangements in Annex XVI of MDR 2017/745 - risk management and transitional provisions]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/regulation-2022-2346-and-2023-11194-74 https://www.csdmed.mc/en/news/medical-devices-regulation/regulation-2022-2346-and-2023-11194-74 Fri, 03 Nov 2023 00:00:00 +0100 <![CDATA[Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/clinical-trial-combined-studies-project-75 https://www.csdmed.mc/en/news/medical-devices-regulation/clinical-trial-combined-studies-project-75 Tue, 14 Nov 2023 00:00:00 +0100 <![CDATA[New issue of the MDCG Position Paper : MDCG 2022-11 revision 1 - Notice to manufacturers and NB]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2022-11-revision1-76 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2022-11-revision1-76 Wed, 29 Nov 2023 00:00:00 +0100 <![CDATA[(EC) 2023/2482 amending Regulation (EC) No 1907/2006]]>
]]> https://www.csdmed.mc/en/news/news/regulation-2023-2482-phtalates-77 https://www.csdmed.mc/en/news/news/regulation-2023-2482-phtalates-77 Tue, 05 Dec 2023 00:00:00 +0100 <![CDATA[New release: MDCG 2021-6 Rev. 1 - Questions & Answers regarding clinical investigation]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2021-6-rev1-78 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2021-6-rev1-78 Tue, 12 Dec 2023 00:00:00 +0100 <![CDATA[MDCG 2023-5 and MDCG 2023-6: two for the price of one - Products without an Intended Medical Purpose under Annex XVI]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2023-5-and-mdcg-2023-6-79 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2023-5-and-mdcg-2023-6-79 Fri, 15 Dec 2023 00:00:00 +0100 <![CDATA[MDCG 2021-27 Rev.1 - roles and responsibilities of importers and distributors of medical devices]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2021-27-rev1-80 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2021-27-rev1-80 Tue, 19 Dec 2023 00:00:00 +0100 <![CDATA[MDCG 2019-07 Rev.1 (PRRC)]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2019-07-rev1-prrc-81 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2019-07-rev1-prrc-81 Tue, 19 Dec 2023 00:00:00 +0100 <![CDATA[MDCG 2023-7  Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR  and on sufficient levels of access to data needed to justify claims of equivalence]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2023-7-exemptions-clinical-investigations-82 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2023-7-exemptions-clinical-investigations-82 Fri, 22 Dec 2023 00:00:00 +0100 <![CDATA[ISO 42001:2023 Artificial intelligence - Management system]]>
]]> https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/iso-42001-2023-artificial-intelligence-83 https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/iso-42001-2023-artificial-intelligence-83 Fri, 22 Dec 2023 00:00:00 +0100 <![CDATA[NANDO base - situation on the 1st January 2024]]>
]]> https://www.csdmed.mc/en/news/news/nando-base-january-2024-84 https://www.csdmed.mc/en/news/news/nando-base-january-2024-84 Thu, 11 Jan 2024 00:00:00 +0100 <![CDATA[language requirements for manufacturers]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/language-requirements-manufacturers-mdr-ivdr-85 https://www.csdmed.mc/en/news/medical-devices-regulation/language-requirements-manufacturers-mdr-ivdr-85 Thu, 18 Jan 2024 00:00:00 +0100 <![CDATA[MDCG 2024-2 about update of EMDN codes]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2024-2-update-emdn-86 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2024-2-update-emdn-86 Tue, 06 Feb 2024 00:00:00 +0100 <![CDATA[IA act: France finally accepts the proposal, under conditions]]>
]]> https://www.csdmed.mc/en/news/news/ia-act-france-finally-accepts-the-proposal-under-conditions-87 https://www.csdmed.mc/en/news/news/ia-act-france-finally-accepts-the-proposal-under-conditions-87 Tue, 06 Feb 2024 00:00:00 +0100 <![CDATA[EU Guide: EUDAMED overview and how to register your company]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/eudamed-overview-88 https://www.csdmed.mc/en/news/medical-devices-regulation/eudamed-overview-88 Thu, 15 Feb 2024 00:00:00 +0100 <![CDATA[ISO and IAF Joint Communiqué about Climate Change]]>
]]> https://www.csdmed.mc/en/news/news/iso-iaf-communique-climat-change-89 https://www.csdmed.mc/en/news/news/iso-iaf-communique-climat-change-89 Thu, 22 Feb 2024 00:00:00 +0100 <![CDATA[HLS structure within ISO-IEC 42001]]>
]]> https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/management-system-hls-structure-90 https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/management-system-hls-structure-90 Sat, 02 Mar 2024 00:00:00 +0100 <![CDATA[NIS 2 Directive]]>
]]> https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/nis2-directive-91 https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/nis2-directive-91 Fri, 08 Mar 2024 00:00:00 +0100 <![CDATA[MDCG 2024-3 guidance - content of the Clinical Investigation Plan (CIP)]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/guide-mdcg-2024-3-92 https://www.csdmed.mc/en/news/medical-devices-regulation/guide-mdcg-2024-3-92 Wed, 13 Mar 2024 00:00:00 +0100 <![CDATA[Harmonized standards up to date in March 2024]]>
]]> https://www.csdmed.mc/en/news/news/harmonized-standards-update-march-2024-93 https://www.csdmed.mc/en/news/news/harmonized-standards-update-march-2024-93 Sun, 17 Mar 2024 00:00:00 +0100 <![CDATA[Competent authorities and medical devices registration]]>
]]> https://www.csdmed.mc/en/news/news/competent-authorities-94 https://www.csdmed.mc/en/news/news/competent-authorities-94 Wed, 27 Mar 2024 00:00:00 +0100 <![CDATA[How far can data support the transformation of health through AI?]]>
]]> https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/data-support-health-transformation-through-ai-95 https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/data-support-health-transformation-through-ai-95 Fri, 05 Apr 2024 00:00:00 +0200 <![CDATA[Statement of Applicability according to section 6.1.3 of ISO/IEC 42001:2023]]>
]]> https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/statement-of-applicability-iso-42001-96 https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/statement-of-applicability-iso-42001-96 Sun, 07 Apr 2024 00:00:00 +0200 <![CDATA[Successful and timely uptake of artificial intelligence in science in the EU]]>
]]> https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/ai-uptake-medical-eu-97 https://www.csdmed.mc/en/news/md-ai-and-cybersecurity/ai-uptake-medical-eu-97 Mon, 15 Apr 2024 00:00:00 +0200 <![CDATA[MDCG 2024-5 - guidance on content of the Investigator’s Brochure for clinical investigations of medical devices]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2024-5-98 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2024-5-98 Wed, 17 Apr 2024 00:00:00 +0200 <![CDATA[Post Market Surveillance]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/post-market-surveillance-pms-99 https://www.csdmed.mc/en/news/medical-devices-regulation/post-market-surveillance-pms-99 Fri, 26 Apr 2024 00:00:00 +0200 <![CDATA[Supercritical CO₂ Sterilization: An Eco-Friendly and Sustainable Alternative for Medical Devices]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/supercritical-co2-sterilization-100 https://www.csdmed.mc/en/news/medical-devices-regulation/supercritical-co2-sterilization-100 Mon, 06 May 2024 00:00:00 +0200 <![CDATA[Insight into the Medical Devices Sector in 2023: Key Data and Trends]]>
]]> https://www.csdmed.mc/en/news/news/insight-into-the-medical-devices-sector-in-2023-key-data-and-trends-101 https://www.csdmed.mc/en/news/news/insight-into-the-medical-devices-sector-in-2023-key-data-and-trends-101 Thu, 16 May 2024 00:00:00 +0200 <![CDATA[Methods Validation for Verification Testing in Medical Devices]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/method-validation-102 https://www.csdmed.mc/en/news/medical-devices-regulation/method-validation-102 Tue, 11 Jun 2024 00:00:00 +0200 <![CDATA[Comprehensive Update on the Guidelines for Benefit-Risk Assessment of CMR/ED Phthalates in Medical Devices]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-scheer-o-064-103 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-scheer-o-064-103 Tue, 18 Jun 2024 00:00:00 +0200 <![CDATA[MDCG 2024-10 Clinical evaluation of orphan medical devices]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2024-10-clinical-evaluation-of-orphan-medical-devices-104 https://www.csdmed.mc/en/news/medical-devices-regulation/mdcg-2024-10-clinical-evaluation-of-orphan-medical-devices-104 Tue, 25 Jun 2024 00:00:00 +0200 <![CDATA[Harmonized structure for IVD regulatory submissions]]>
]]> https://www.csdmed.mc/en/news/medical-devices-regulation/imdrf-ivd-toc-v4-105 https://www.csdmed.mc/en/news/medical-devices-regulation/imdrf-ivd-toc-v4-105 Wed, 26 Jun 2024 00:00:00 +0200