Hot News: Revised Version of the MDCG Guidance on Standardisation for Medical Devices, Now Available! Exciting news! The revised and improved version of the MDCG guidance document "MDCG 2021-5 Rev.1 - Guidance on standardisation for medical devices - July 2024" has been officially endorsed by the MDCG and is now accessible on the European Commission EU Health and Food Safety DG SANTE webpage. This updated version includes new sections on the rulings of the Court of Justice of the European Union, the European Pharmacopoeia, and Common Specifications, offering a comprehensive reference on various aspects of standardisation in support of EU Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR). For detailed insights and practical guidance, check out the document directly via the link below. https://lnkd.in/dFZQMK5Y For further information and assistance, contact MEDIcept at sales@medicept.com for expert support and guidance in navigating the standards landscape in the medical devices sector. #MDCG #Standards #MedicalDevices #EU #Regulations #MDR #IVDR #Standardisation #EuropeanCommission #Healthcare #Guidance #MedTech
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The "IEC 60601 Guy" | Medical Device Consultant | Product Safety Compliance & Regulatory | Evolving Medical Device Standards
MDCG 2021-5, revision 1, 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝗶𝘀𝗮𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 - Just released 2024-July-02. 𝗞𝗲𝗲𝗽 𝘂𝗽 𝘁𝗼 𝗱𝗮𝘁𝗲 on this important document for the #EU impacts you as a #medicaldevice or #IVD manufacturer. Thank you Mario Gabrielli Cossellu for an excellent summary of new sections on the rulings of the Court of Justice of the European Union, on the #EuropeanPharmacopoeia and on #CommonSpecifications and on revisions and clarification (also see page 2 which lists the pages changed). BUT read Mario's commentary below it is very insightful. #standards #standardization #standardisation #meddevice #combodevice #combinationdevice #regulatory #quality #RA #QA #RAQA #qualityassurance
Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
❗ REVISED VERSION OF THE MDCG GUIDANCE ON STANDARDISATION FOR MEDICAL DEVICES, NOW AVAILABLE ❗ After the appropriate drafting, consultation and approval procedures in the relevant Subgroups on #Standards (WG 2), Notified Bodies Oversight (#NBO, WG 1) and In Vitro Diagnostic Medical Devices (#IVD, WG 11) of the Medical Device Coordination Group (#MDCG), a new revised and improved version of the guidance document "MDCG 2021-5 Rev.1 - Guidance on standardisation on medical devices - July 2024" has been endorsed by the #MDCG and published on the European Commission EU Health and Food Safety DG #SANTE webpage on "Public Health > Medical Devices - Sector > New Regulations - Guidance > Standards" https://lnkd.in/eqJ3V28Q. ✔ With respect to the previous version endorsed and published in April 2021, the new revised document - in addition to several updates and certain clarifications - includes new sections on the rulings of the Court of Justice of the European Union, on the #EuropeanPharmacopoeia and on #CommonSpecifications. This way, the document represents a landmark reference and a quite comprehensive guidance on the different horizontal and vertical aspects related to #Standardisation in support of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR), to provide consolidated information and practical guidance from both technical and legal points of view. 👉 The document is directly accessible as https://lnkd.in/eRRk3zPG.
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MDCG 2021-5, revision 1, 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝗶𝘀𝗮𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 - Just released 2024-July-02. 𝗞𝗲𝗲𝗽 𝘂𝗽 𝘁𝗼 𝗱𝗮𝘁𝗲 on this important document for the #EU impacts you as a #medicaldevice or #IVD manufacturer. Thank you Mario Gabrielli Cossellu for an excellent summary of new sections on the rulings of the Court of Justice of the European Union, on the #EuropeanPharmacopoeia and on #CommonSpecifications and on revisions and clarification (also see page 2 which lists the pages changed). BUT read Mario's commentary below it is very insightful. #standards #standardization #standardisation #meddevice #combodevice #combinationdevice #regulatory #quality #RA #QA #RAQA #qualityassurance
Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
❗ REVISED VERSION OF THE MDCG GUIDANCE ON STANDARDISATION FOR MEDICAL DEVICES, NOW AVAILABLE ❗ After the appropriate drafting, consultation and approval procedures in the relevant Subgroups on #Standards (WG 2), Notified Bodies Oversight (#NBO, WG 1) and In Vitro Diagnostic Medical Devices (#IVD, WG 11) of the Medical Device Coordination Group (#MDCG), a new revised and improved version of the guidance document "MDCG 2021-5 Rev.1 - Guidance on standardisation on medical devices - July 2024" has been endorsed by the #MDCG and published on the European Commission EU Health and Food Safety DG #SANTE webpage on "Public Health > Medical Devices - Sector > New Regulations - Guidance > Standards" https://lnkd.in/eqJ3V28Q. ✔ With respect to the previous version endorsed and published in April 2021, the new revised document - in addition to several updates and certain clarifications - includes new sections on the rulings of the Court of Justice of the European Union, on the #EuropeanPharmacopoeia and on #CommonSpecifications. This way, the document represents a landmark reference and a quite comprehensive guidance on the different horizontal and vertical aspects related to #Standardisation in support of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR), to provide consolidated information and practical guidance from both technical and legal points of view. 👉 The document is directly accessible as https://lnkd.in/eRRk3zPG.
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Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
❗ REVISED VERSION OF THE MDCG GUIDANCE ON STANDARDISATION FOR MEDICAL DEVICES, NOW AVAILABLE ❗ After the appropriate drafting, consultation and approval procedures in the relevant Subgroups on #Standards (WG 2), Notified Bodies Oversight (#NBO, WG 1) and In Vitro Diagnostic Medical Devices (#IVD, WG 11) of the Medical Device Coordination Group (#MDCG), a new revised and improved version of the guidance document "MDCG 2021-5 Rev.1 - Guidance on standardisation on medical devices - July 2024" has been endorsed by the #MDCG and published on the European Commission EU Health and Food Safety DG #SANTE webpage on "Public Health > Medical Devices - Sector > New Regulations - Guidance > Standards" https://lnkd.in/eqJ3V28Q. ✔ With respect to the previous version endorsed and published in April 2021, the new revised document - in addition to several updates and certain clarifications - includes new sections on the rulings of the Court of Justice of the European Union, on the #EuropeanPharmacopoeia and on #CommonSpecifications. This way, the document represents a landmark reference and a quite comprehensive guidance on the different horizontal and vertical aspects related to #Standardisation in support of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR), to provide consolidated information and practical guidance from both technical and legal points of view. 👉 The document is directly accessible as https://lnkd.in/eRRk3zPG.
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MDCG provides us with updated background information on European standardisation of MD. Their guidelines are taken seriously by Notified Bodies and manufacturers alike. If you are not actively involved in standardisation but use them at a manufacturer of MD, you may want to especially consider page 9, section 3.5 and the “Orona case” on page 21. Or do you enjoy contexts in legalese? Read the whole document, of course.
Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
❗ REVISED VERSION OF THE MDCG GUIDANCE ON STANDARDISATION FOR MEDICAL DEVICES, NOW AVAILABLE ❗ After the appropriate drafting, consultation and approval procedures in the relevant Subgroups on #Standards (WG 2), Notified Bodies Oversight (#NBO, WG 1) and In Vitro Diagnostic Medical Devices (#IVD, WG 11) of the Medical Device Coordination Group (#MDCG), a new revised and improved version of the guidance document "MDCG 2021-5 Rev.1 - Guidance on standardisation on medical devices - July 2024" has been endorsed by the #MDCG and published on the European Commission EU Health and Food Safety DG #SANTE webpage on "Public Health > Medical Devices - Sector > New Regulations - Guidance > Standards" https://lnkd.in/eqJ3V28Q. ✔ With respect to the previous version endorsed and published in April 2021, the new revised document - in addition to several updates and certain clarifications - includes new sections on the rulings of the Court of Justice of the European Union, on the #EuropeanPharmacopoeia and on #CommonSpecifications. This way, the document represents a landmark reference and a quite comprehensive guidance on the different horizontal and vertical aspects related to #Standardisation in support of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR), to provide consolidated information and practical guidance from both technical and legal points of view. 👉 The document is directly accessible as https://lnkd.in/eRRk3zPG.
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📢 Published by the EU Commission the "𝗦𝘁𝘂𝗱𝘆 𝗼𝗻 𝘁𝗵𝗲 𝗶𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟭𝟳 𝗼𝗳 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟭𝟳/𝟳𝟰𝟱 𝗼𝗻 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 𝗼𝗻 𝘁𝗵𝗲 𝗘𝗨 𝗺𝗮𝗿𝗸𝗲𝘁" 🔬 Its primary objective is to evaluate the implementation of Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) across European countries, focusing on the reprocessing of single-use devices (SUDs). 📊 Commissioned by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA), the survey started in December 2022 and spanned 30 European countries, analyzing the current market landscape for the reprocessing and reuse of SUDs. Download the full document >> https://lnkd.in/dmuuijUH #MedicalDevices #MDR #MedicalDeviceRegulation #SingleUseDevices #RegulatoryCompliance
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Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
The availability of safe medical devices is essential for patient care. The European Commission EU Health and Food Safety DG #SANTE services in charge of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedical Devices (#IVDR) welcome today's adoption by the Council of the European Union of new rules to improve the availability of in vitro diagnostics (#IVDs) by fully extending the transition period for certain IVDs, enabling a gradual roll-out of the #Eudamed, the new European database on medical devices, and requiring manufacturers to flag up potential shortages of critical medical devices and IVDs. See more information here: https://lnkd.in/ejPwnFkw #HealthUnion #EUDelivers
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Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
The November 2023 Revision 1 of the "MDCG 2022-11 MDCG Position Paper - Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements" is now published as https://lnkd.in/eCtyBpVf on the European Commission EU Health and Food Safety DG #SANTE webpage on "Public Health > Medical Devices - Sector > New Regulations > Guidance" https://lnkd.in/e3jct9JG. #MedicalDevices #MDR #InVitroDiagnosticMedicalDevices #IVDR #MDCG
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✅ Update to #MDCG 2022-11 now released which presents the current #statusquo on the #MDR and #IVDR Transition. 📣 Calls are made to #medtech industry to hurry up especially IVD and submit #complete and #highquality applications (unclear how this is defined and if changed NB expectations over time contribute to this). 📣 Calls are also made to #notifiedbodies on #structureddialogues that should be part of the application process and ⛔️not be charged additionally. I hope this can challenge the ⏰ time taken to get certified and the 💶💶💶 costs involved for industry. #stillmoretodo #willitmaketheboatgofaster
Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
The November 2023 Revision 1 of the "MDCG 2022-11 MDCG Position Paper - Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements" is now published as https://lnkd.in/eCtyBpVf on the European Commission EU Health and Food Safety DG #SANTE webpage on "Public Health > Medical Devices - Sector > New Regulations > Guidance" https://lnkd.in/e3jct9JG. #MedicalDevices #MDR #InVitroDiagnosticMedicalDevices #IVDR #MDCG
Guidance - MDCG endorsed documents and other guidance
health.ec.europa.eu
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The state of industry-serving, medical devices regulation in the EU #medicaldevices #patientsafety #unaccountable #lobbycentral #dangerousdevices #biocompatibility #womenshealthmatters but not in the #EU #stockholmconvention #EDCs ☠️ #chemicalpoisoning #criminalendangerment #CE #REACH
Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
After the endorsement by the Medical Device Coordination Group (#MDCG) at the meeting held on 11-12 December, the European Commission EU Health and Food Safety DG #SANTE services in charge of the #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR) published two new #Guidance documents on the products without an intended medical purpose listed in #AnnexXVI to the MDR, specifically addressed to #Manufacturers and #NotifiedBodies: ▶ MDCG 2023-5 Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies https://lnkd.in/dcvcD9bK ▶ MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies https://lnkd.in/dGCJX2MR 👉 All the "MDCG endorsed documents and other guidance" are available on the webpage on "Public Health > Medical Devices - Sector > New Regulations > Guidance" https://lnkd.in/e3jct9JG.
Guidance - MDCG endorsed documents and other guidance
health.ec.europa.eu
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Ingegnere Elettrotecnico, Ingeniero Industrial, Abogado. Principal Administrator, Legal and Policy Officer at European Commission
Today 26 September 2023, a guidance document on #AnnexXVI #MDR products has been published as "Q&A ON TRANSITIONAL PROVISIONS FOR PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE COVERED BY ANNEX XVI OF THE MDR" https://lnkd.in/dJD5QRzZ. It is available on the European Commission EU Health and Food Safety webpage "Public Health > Medical Devices - Sector > New Regulations > Guidance" https://lnkd.in/dP4xMF_N. #EU #HealthUnion #Health #SANTE #MedicalDevices
Guidance - MDCG endorsed documents and other guidance
health.ec.europa.eu
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