Guides MDCG : Calendrier et Suivi des publications

Par Guillaume Promé
le
1 Mar. 2021 Listes et Datas, MDCG, Veille gratuite
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
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

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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

Chronologie