Guides MDCG : Calendrier et Suivi des publications
dernière modification : 18 mai 2022
Cette page reprend l’historique des documents planifiés et publiés par les groupes de travail MDCG. Le tableau de suivi est mis à jour au fil des publications et annonces.
Dernier document ajouté : MDCG 2020-18
Guides MDCG publiés et à venir
Lien vers la dernière mise à jour du planning.
* : décalé par la révision de décembre 2019
** : décalé par la révision de mai 2020
*** : décalé par la révision d’octobre 2020
**** : décalé par la révision de décembre 2020
** : décalé par la révision de mai 2020
*** : décalé par la révision d’octobre 2020
**** : décalé par la révision de décembre 2020
| Document | Date de publication | Date prévue |
|---|---|---|
| MDCG-WG1 : Surveillance des organismes notifiés (NBO) | ||
| NBOG BPG 2017-1 : Best practice guidance on designation and notification of conformity assessment bodies | févr-18 | |
| NBOG BPG 2017-2 : Best practice guidance on the information required for personnel involved in conformity assessment | févr-18 | |
| NBOG F 2017-1 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) | févr-18 | |
| NBOG F 2017-2 : Application form to be submitted by a conformity assessment body when applying for designation as a notified body under the in vitro diagnostic devices regulation (IVDR) | févr-18 | |
| NBOG F 2017-3 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) | févr-18 | |
| NBOG F 2017-4 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) | févr-18 | |
| NBOG F 2017-5 : Preliminary assessment review template (MDR) | févr-18 | |
| NBOG F 2017-6 : Preliminary assessment review template (IVDR) | févr-18 | |
| NBOG F 2017-7 : Review of qualification for the authorisation of personnel (MDR) | févr-18 | |
| NBOG F 2017-8 : Review of qualification for the authorisation of personnel (IVDR) | févr-18 | |
| MDCG 2018-8 : Guidance on content of the certificates, voluntary certificate transfers | nov-18 | |
| MDCG 2019-9 : Summary of safety and clinical performance (RCSPC) | août-19 | |
| MDCG 2019-6 v2 : Questions and answers: Requirements relating to notified bodies | ||
| MDCG 2019-10 : Application of transitional provisions concerning validity of certificates issued in accordance to the directives | oct-19 | |
| MDCG 2019-12 : Designating authority’s final assessment form: Key information (EN) | oct-19 | |
| MDCG 2019-13 : Sampling of devices on a representative basis | dec-19 | |
| MDCG 2019-14 Explanatory note on codes | dec-19 | |
| MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD | mars-20 | |
| MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions | avril-20 | |
| MDCG 2020-11 : Orientations sur le renouvellement de la désignation et la surveillance des organismes notifiés | mai-20 | |
| MDCG 2020-12 : Orientations sur les dispositions transitoires pour les consultations des autorités sur les DM incorporant une substance qui peut être considérée comme un médicament et qui a une action accessoire, ainsi que sur les DM fabriqués à partir de tissus animaux | juin-20 | |
| MDCG 2020-14 : Orientations pour les organismes notifiés sur l’utilisation des rapports d’audit MDSAP dans le cadre des audits de surveillance effectués en vertu des règlements DM et DM-DIV | juin-20 | |
| MDCG 2020-17 : FAQ sur les audits à distance en période covid | dec-20 | |
| Batch verification on class D IVDs | Q1 2021*** | |
| Q&A related to MDCG 2020-4 | 2020*** | |
| Q&A on Notified bodies – new questions to be added to the document already published | Q1 2021**** | |
| Updates of guidance documents and templates on the designation and re-assessment process | 2021*** | |
| Updates of guidance documents and templates on qualification and authorisation of personnel | 2021*** | |
| Guidance on Certifications according to Article 16 | 2021*** | |
| Guidance on appropriate surveillance according to Article 120(3) | 2021*** | |
| Guidance on NB opinions on the conformity of the device part according to Article 117 MDR | 2021**** | |
| Explanatory note on codes | Q1 2021*** | |
| Guidance on clinical evaluation consultation procedure | 2021**** | |
| MDCG-WG2 : Normes (STAND) | ||
| Commission Implementing Decision (Standardisation request) | 2020* | |
| MDR/IVDR Standardisation Request | 2021*** | |
| Guidance on standardisation in the medical devices field | 2020*** | |
| MDCG-WG3 : Évaluations et Investigations Cliniques (CIE) | ||
| MDCG 2020-5 Clinical Evaluation – Equivalence | avril-20 | |
| MDCG 2020-6Guidance on Sufficient Clinical Evidence for Legacy Devices | avril-20 | |
| MDCG 2020-7 Post-market clinical follow-up PMCF Plan Template. A guide for manufacturers and notified bodies | avril-20 | |
| MDCG 2020-8 Post-market clinical follow-up PMCF Evaluation Report Template. A guide for manufacturers and notified bodies | avril-20 | |
| MDCG 2020-10/1 Guidance on safety reporting in clinical investigations | mai-20 | |
| MDCG 2020-10/2 Appendix: Clinical investigation summary safety report form | mai-20 | |
| MDCG 2020-13 Modèle de rapport d’évaluation clinique | juil-20 | |
| Applicability of clinical evaluation consultation procedure | ?? | |
| Clinical investigation application template | 2021**** | |
| Clinical investigation assessment template | 2021**** | |
| Clinical Investigation Report Summary Templat | 2021**** | |
| Processes and templates relative to clinical investigation and performance study Assessments | 2020** | |
| Template PMCF Plan Update | 2020* | |
| Serious Adverse Event reporting EUDAMED requirements – form | 2020** | |
| Report form for Serious Adverse Events | 2020** | |
| Process flow for Serious Adverse Event reporting | 2020** | |
| Q & A on clinical investigation | 2021**** | |
| MDCG-WG4 : Surveillance Après Commercialisation et Vigilance (PMSV) | ||
| Post-Market Surveillance requirements | ? | |
| Vigilance requirements | 2021**** | |
| Development of harmonised reporting forms for incidents | 2021**** | |
| Field Safety Corrective Action Report | ?? | |
| Guidance for PSUR | ?? | |
| Manufacturer Periodic Summary Report | ?? | |
| PSUR template | ?? | |
| MDCG-WG5 : Surveillance du marché (MS) | ||
| MDCG 2019-15 : Guidance notes form manufacturers of Class I medical devices | dec-19 | |
| Update of PRRC (Person Responsible for Regulatory Compliance) document | 2021**** | |
| Authorised Representatives | 2021**** | |
| Guidelines on Re-labelling & Re-packaging | 2021**** | |
| In-house manufacturers | 2021**** | |
| Q&A on Custom-Made & Adaptable Devices* | 2021**** | |
| Q&A on Importers & Distributors | 2021**** | |
| MDCG-WG6 : Cas limites et classification (B&C) | ||
| Borderline with medicinal products (including general guidance, definitions of pharmacological, immunological and metabolic means of action and diagnosis, and consultation procedures of medicines authorities) | 2021**** | |
| Classification of medical devices | 2021*** | |
| MDCG-WG7 : Nouvelles technologies (NET) | ||
| MDCG 2019-11 : Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | oct-19 | |
| MDCG 2020-1 : Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | mars-20 | |
| MDCG 2019-16 : Cybersecurity of Software | janv-20 | |
| Legal status of app providers* | 2021**** | |
| Artificial Intelligence* under MDR/IVDR framework of Software |
?*** | |
| MDCG-WG8 : Eudamed | ||
| MDCG 2018-2 : Future EU medical device nomenclature – Description of requirements | mars-18 | |
| MDCG 2018-3 : Guidance on UDI for systems and procedure packs | oct-18 | |
| MDCG 2018-4 : Definitions/descriptions and formats of the UDI core elements for systems or procedure packs | oct-18 | |
| MDCG 2018-5 : UDI assignment to medical device software | oct-18 | |
| MDCG 2018-6 : Clarifications of UDI related responsibilities in relation to article 16 | oct-18 | |
| MDCG 2018-7 : Provisional considerations regarding language issues associated with the UDI database | oct-18 | |
| MDCG 2019-1 : MDCG guiding principles for issuing entities rules on basic UDI-DI | janv-19 | |
| 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 | févr-19 | |
| MDCG 2018-1 v3 : Guidance on basic UDI-DI and changes to UDI-DI | mars-20 | |
| MDCG 2019-4 : Timelines for registration of device data elements in EUDAMED | avr-19 | |
| MDCG 2019-5 : Registration of legacy devices in EUDAMED | avr-19 | |
| MDCG 2020-15 : position du MDCG sur l’utilisation du module d’enregistrement des acteurs EUDAMED et du numéro d’enregistrement unique (SRN) dans les États membres | aout-19 | |
| MDCG 2021-1 : Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | fevr-21 | |
| MDCG-WG9 : Identifiant unique du dispositif (UDI) | ||
| MDCG 2018-18 : MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers | dec-20 | |
| Integration of UDI in manufacturers’ QMS | 2021**** | |
| Guidelines on specific product types (contact lenses) | 2021**** | |
| Formats of AICD and HRI parts of UDI carriers** | 2020** | |
| List of values for certain data fields (clinical size + warnings and contraindications) | 2020* | |
| Adaptation of Annexes to IMDRF N48 ‘UDI System Application Guide | 2021**** | |
| MDCG-WG10 : Questions internationales (INT) | ||
| Taking into account MDSAP for NB | 2020*** | |
| MDCG-WG11 : Dispositifs médicaux de diagnostic in-vitro (IVD) | ||
| MDCG 2020-16 : Orientations sur les règles de classification pour les dispositifs médicaux de diagnostic in vitro en vertu du Règlement (UE) 2017/746 | nov-20 | |
| Performance evaluation | 2021*** | |
| SSP template and guidance | ? | |
| Transfer of CTS to CS | 2021*** | |
| Development of common specifications | ? | |
| Qualification of assays used in clinical trials of medicinal products | ? | |
| Guidance on state of the art for COVID-19 antibody tests | 2020*** | |
| Q&A on IVDs in context of COVID-19 | 2020*** | |
| MDCG-WG12 : Nomenclature | ||
| Information package on EMDN (European Medical Device Nomenclature) for website | 2020** | |
| Rules and process for update of EMDN | 2020* | |
| 1st release of EMDN | Q4 2020*** | |
| Mapping CND-GMDN package | ?*** | |
| Translation of EMDN | ? | |
| List of EMDN terms to be used for implant card purposes | 2021*** | |
| Rules for allocation of EMDN to UDI-DI | Q1 2021*** | |
| Procedures for the annual and ad-hoc updates of EMDN | Q1 2021*** | |
| MDCG-WG13 : Annexe XVI | ||
| Qualification of devices listed in Annex XVI | ?? | |
| Common Specifications for devices listed in Annex XV | 2021**** | |
| Divers | ||
| MDCG 2019-7 : 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) | juin-19 | |
| MDCG 2019-8 v2 : Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | mars-20 | |
| MDCG 2020-1 : Class I transitional provisions under Article 120 (3 and 4) – (MDR) | mars-20 | |
| MDCG 2020-9 : Exige,nces règlementaires pour les respirateurs | mars-20 | |
| MDCG 2019-3 rev1 : Interpretation de l’article 54.2.b | avril-20 | |
| Common Specifications for devices listed in Annex XV | 2021*** | |
Avancement
Avancement général
Avancement par Working Group
Cliquez pour avoir le détail des noms des groupes :
- MDCG-WG1
- MDCG-WG2
- MDCG-WG3
- MDCG-WG4
- MDCG-WG5
- MDCG-WG5
- MDCG-WG7
- MDCG-WG8
- MDCG-WG9
- MDCG-WG10
- MDCG-WG11
- MDCG-WG12
- MDCG-WG13
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