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Articles
- Compte-rendu de la réunion du MDCG du 19 juin : du nouveau concernant les normes harmonisées !
- MDCG 2018-1 Rev. 4 : Guidance on basic UDI-DI and changes to UDI-DI – March 2020
- MDCG 2018-2 : Future EU medical device nomenclature – Description of requirements – Mars 2018
- MDCG 2018-3 Rev.1 : Guidance on UDI for systems and procedure packs – June 2018
- MDCG 2018-4 : Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs – October 2018
- MDCG 2018-5 : UDI Assignment to Medical Device Software – October 2018
- MDCG 2018-6 : Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 – October 2018
- MDCG 2018-7 : Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745 – October 2018
- MDCG 2018-8 : Guidance on Content of the certificates, voluntary certificate transfers – November 2018
- MDCG 2019-1 : MDCG guiding principles for issuing entities rules on Basic UDI-DI – January 2019
- MDCG 2019-2 : Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 – February 2019
- MDCG 2019-3 rev 1 : Interpretation of Article 54(2)b – April 2020
- MDCG 2019-4 : Timelines for registration of device data elements in EUDAMED – April 2019
- MDCG 2019-5 : Registration of legacy devices in EUDAMED – April 2019
- MDCG 2019-6 Rev. 4 : Questions and answers : Requirements relating to notified bodies – October 2019
- MDCG 2019-7 Rev.1 : Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) – June 2019
- MDCG 2019-8 v2 : Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices – March 2020
- MDCG 2019-9 Rev. 1 : Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019
- MDCG 2019-10 rev 1 : Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC – October 2019
- MDCG 2019-11 : Guidance on qualification and classification of software in regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR – October 2019
- MDCG 2019-12 : Designating authority’s final assessment form: Key Information (EN) – October 2019
- MDCG 2019-13 : Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation – December 2019
- MDCG 2019-14 : Explanatory note on MDR codes – December 2019
- MDCG 2019-15 Rev.1 : Guidance notes for manufacturers of class I medical device – December 2019
- MDCG 2019-16 Rev.1 : Guidance on cybersecurity for medical devices – December 2019
- MDCG 2020-1 : Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software – March 2020
- MDCG 2020-2 Rev. 1 : Class I Transitional provisions under Article 120 (3 and 4) – (MDR) – March 2020
- MDCG 2020-3 Rev.1 : Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD and AIMDD – March 2020
- MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions – April 2020
- MDCG 2020-5: Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies – April 2020
- MDCG 2020-6 : Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC – April 2020
- MDCG 2020-7 : Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies – April 2020
- MDCG 2020-8 : Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies – April 2020
- MDCG 2020-9 : Regulatory requirements for ventilators and related accessories – April 2020
- MDCG 2020-10/1 Rev. 1 : Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 – May 2020
- MDCG 2020-11 – Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation – April
- MDCG 2020-12 : Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues – June 2020
- MDCG 2020-13 : Clinical evaluation assessment report template : July 2020.
- MDCG 2020-14 : Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the MDR/IVDR – August 2020.
- MDCG 2020-15: MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member states – August 2020.
- MDCG 2020-16 Rev. 3 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – Juillet 2024
- MDCG 2020-18 : MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers – Decembre 2020
- MDCG 2020-17 : Questions and Answers related to MDCG 2020-4 – Décembre 2020
- Nouveau guide MDCG 2021 -1 : Solutions techniques et procédures administratives en l’absence d’EUDAMED
- MDCG 2021-1 Rev. 1 : Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional – February 2021
- MDCG 2021-2 : MDCG Guidance on state of the art of COVID-19 rapid antibody tests – March 2021
- MDCG 2021-3 : Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices – March 2021
- 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 – April 2021
- MDCG 2021-5 Rev.1 : Guidance on standardisation for medical devices – April 2021
- MDCG 2021-6 Rev.1 : Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation – April 2021
- MDCG 2021-7 : Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices – May 2021
- MDCG 2021-8 : Clinical investigation application/notification documents – May 2021
- MDCG 2021-09 : Position paper on the implementation of UDI requirements for contact lenses, spectacle frames, spectacles lenses & ready readers – May 2021
- MDCG 2021- 10 – The status of appendixes E-I of IMDRF N48 under the EU regulatory framework for medical device – May 2021
- MDCG 2021-11 : Guidance on implant card ‘Device types’ – May 2021 – V1.1
- MDCG 2021- 12 – FAQ on the European Medical Device Nomenclature (EMDN) – May 2021 – V1.1
- MDCG 2021-13 Rev. 1 : Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR – June 2021
- MDCG 2021-17 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) – July 2021 MDCG 2021-18 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) – July 2021
- MDCG 2021-19 : Guidance note integration of the UDI within an organisation’s quality management system – July 2021
- MDCG 2021-20 : Instructions for generating CIV-ID for MDR Clinical Investigations – July 2021
- MDCG 2021-21 Rev. 1 : Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices – August 2021
- MDCG 2021-22 Rev. 1 : Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 – August 2021
- MDCG 2021-23 : Guidance for notified bodies, distributors and importers on certification activities in accordance with Article (16)4 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – August 2021
- MDCG 2021-14 : Explanatory note on IVDR codes – July 2021
- MDCG 2021-15 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) – July 2021 MDCG 2021-16 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) – July 2021
- Synthèses documents du MDCG
- MDCG 2021-24 : Guidance on classification of medical devices – Octobre 2021
- MDCG 2021-27 Rev.1 : Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Décembre 2021
- MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation – Décembre 2021
- MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices – Janvier 2022
- MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) – Janvier 2022
- MDCG 2022-3: Verification of manufactured class D IVDs by notified bodies
- 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 the AIMDD
- MDCG 2022-5 : Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
- MDCG 2022-6 : Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
- MDCG 2022-7 : MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- MDCG 2022-8 : Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
- MDCG 2022-9 REV 1 : Summary of safety and performance Template
- MDCG 2022-10 : Q&A 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 (IVDR)
- MDCG 2022-11 Rev.1 : MDCG Position Paper Notice to manufacturers to ensure timely compliance with MDR requirements – Juin 2022
- MDCG 2022-12 : Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) – Juillet 2022
- MDCG 2022-13 Rev.1 : Designation, re-assessment and notification of conformity assessment bodies and notified bodies – Aout 2022
- MDCG 2022-14 : Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs – Août 2022
- MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD – Septembre 2022
- MDCG 2022-16 : Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – Octobre 2022
- MDCG 2022-17 : MDCG position paper on ‘hybrid audits’– Décembre 2022
- MDCG 2022-18 : MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate – Décembre 2022
- MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746 – Décembre 2022
- MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746 – Décembre 2022
- MDCG 2023-5 : Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies
- MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies
- 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
- MDCG 2024-1 Guidance on the vigilance system for CE-marked devices – DSVG 00 Device Specific Vigilance Guidance Template
- MDCG 2024-2 : Procedures for the updates of the European Medical Device Nomenclature
- MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 – Avril 2024
- MDCG 2024-5 – Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices – Avril 2024
- MDCG 2024-6 – Preliminary re-assessment review template – MDR (Regulation (EU) 2017/745) – Mai 2024
- MDCG 2024-7 – Preliminary assessment review (PAR) form template (MDR) – May 2024
- MDCG 2024-8 – Preliminary assessment review template – IVDR (Regulation (EU) 2017/746) – May 2024
- MDCG 2024-9 – Preliminary re-assessment review template – IVDR (Regulation (EU) 2017/746) – Mai 2024
- MDCG 2024-10 – Clinical evaluation of orphan medical devices – Juin 2024
- Report d’un an de la date d’application du Règlement (UE) 2017/745
- Retraitement des dispositifs à usage unique : spécifications communes tant attendues !
- Conformité RGPD et transfert de données vers les pays tiers : la CJUE se prononce
- Masques et visières : un statut étroitement dépendant de la destination assignée
- Désignation du GMED en application du Règlement DM
- Règlements et Normes Européennes Harmonisées
- Organismes notifiés du Groupe AFNOR
- Vente de dispositifs médicaux sur internet
- Mise à jour du Rolling Plan
- MHRA : nouveaux guides en cette fin de période de transition !
- Comment le Règlement va impacter vos veilles
- Pandémie COVID-19 et masques : Point sur la situation
- Nouvelle et dernière version du Règlement relatif aux dispositifs médicaux !
- Canada : classification des produits mixtes médicaments/matériel médical
- Une réponse à une question récurrente : dans quelle langue écrire mes étiquettes et notices de DM ?
- Argentine et Brésil – nouvelles exigences réglementaires pour les dispositifs médicaux à base de latex
- AUSTRALIE – TGA – Nouvelles exigences relatives à certaines évaluations de conformité
- Reconnaissance des prescriptions de dispositifs médicaux établies dans un autre État membre de l’Union Européenne
- Consultation des groupes d’experts selon le RDM : comprendre la construction et l’esprit de la loi
- Impact du Brexit sur la Réglementation des Dispositifs Médicaux
- Guide Complet sur la Conformité Règlementaire des Dispositifs Médicaux en Europe
- Suisse – non renouvellement de l’Accord de Reconnaissance Mutuelle avec l’UE : ajustements ou réel bouleversement?
- Démontrer de manière scientifique le bénéfice clinique et la sécurité d’un dispositif médical de diagnostic in vitro (DMDIV)
- Nouvelles normes harmonisées en vertu des Règlement DM et DMDIV : tout ce qu’il faut savoir sur la présomption de conformité
- Vente de dispositifs médicaux de diagnostic in vitro sur internet
- Nouveau Règlement d’exécution relatif aux instructions d’emploi électroniques : dans quelles conditions peut-on se passer du format papier ? Quelles modifications ont été apportées ?
- Dispositifs médicaux de diagnostic in vitro : La Commission propose d’étendre les durées des dispositions transitoires
- Nouvelles listes de normes harmonisées – 2015
- Évolutions récentes de l’évaluation biologique de vos produits : Etats des lieux
- A moins de 16 mois de la date d’application du règlement (UE) 2017/746, avez-vous pris les devants ? Il est urgent d’agir !
- Communication de la Commission concernant les mesures extraordinaires temporaires, y compris les audits à distance
- Règlements DM et DMDIV et normes : où en est-on ?
- La minute règlementaire : IUD et EUDAMED, les distributeurs sont-ils concernés ?
- La minute règlementaire – Choisir la procédure d’évaluation de la conformité de son DM : no stress !
- La minute règlementaire : IUD, EUDAMED, quelles obligations ?
- Mise sur le marché, mise à disposition sur le marché, mise en service : quelles différences ?
- Transition: la FAQ DIV du CAMD passée au crible
- Résumé des caractéristiques du dispositif médical
- Classification des DM DIV sous le Règlement: une refonte complète
- A la recherche d’un organisme notifié désigné sous le Règlement ?
- Publication par la Commission Européenne du nouveau Manufacturer Incident Report : « MIR »
- BREXIT – HELP, YOU NEED SOME (NOTIFIED) BODY !
- FORMATION RÈGLEMENT (UE) 2017/745
- UPDATE BREXIT – HELP, YOU NEED SOME (NOTIFIED) BODY
- Transition: les FAQ DM & DM DIV du CAMD passées au crible
- innov’Health : une veille règlementaire sur-mesure pour les startups
- Loi « anti-cadeaux »: ce qu’il faut retenir, ce qui va changer
- Règlement relatif à la protection des données personnelles
- La France protège encore plus ses citoyens
- Attention au suif !
- Proactifs, les Pays-Bas décident de mettre en place l’Identification Unique des Dispositifs dès le 1er juillet 2018
- Les Directives, la fin d’une ère
- Publication de 5 documents relatifs à l’utilisation des normes par les pays membres de l’IMDRF
- Adoption des Règlements relatifs aux dispositifs médicaux et dispositifs médicaux de diagnostic in vitro par le Parlement européen !
- Dispositifs médicaux fabriqués à partir de tissus d’origine animale
- USA – L’EMDR, un nouveau système de déclaration électronique des dispositifs médicaux
- USA : mise à jour des guidances relatives aux soumissions 510(k)s
- ANSM
- Nouvelles listes des normes harmonisées
- Nexinform, Une solution innovante de veille réglementaire et normative
- Votre organisme notifié est dénotifié : comment prolonger les certificats ?
- Nouvelle et dernière version du Règlement relatif aux dispositifs médicaux de diagnostic in vitro !
- Hébergement des données de santé : D’ici le 1er octobre 2016, relisez vos contrats !
- Publication des Règlements relatifs aux dispositifs médicaux et dispositifs médicaux de diagnostic in vitro
- FDA : Consultez la liste complète des 1 003 dispositifs médicaux exemptés de 510 (k)
- Classification sous le Règlement : quelles évolutions ?
- Nanomatériaux : la règlementation pour les tous petits
- Découvrez les nouvelles listes des normes harmonisées
- Règlement DM : suis-je concerné(e) ?
- Fin de la Directive pour les DM DIV : mode d’emploi
