Guides MDCG : Calendrier et Suivi des publications

28 mai 2020 Règlement (UE) 2017/745 1 commentaire
dernière modification : 28 mai 2020


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.

Liste des documents MDCG publiés et à venir

* : décalé par la révision de décembre 2019
** : décalé par la révision de mai 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 oct-19
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 2019-13Sampling of devices on a representative basis dec-2019
MDCG 2019-14 Explanatory note on codes dec-2019
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
Q&A on Notified bodies – new questions to be added to the document already published 2020
Batch verification on class D IVDs 2020**
MDCG-WG2 : Normes  (STAND)
Commission Implementing Decision (Standardisation request) 2020*
MDCG-WG3 : Évaluations et Investigations Cliniques (CIE)
MDCG 2020-5 Clinical Evaluation – Equivalence avril-2020
MDCG 2020-6Guidance on Sufficient Clinical Evidence for Legacy Devices avril-2020
MDCG 2020-7 Post-market clinical follow-up PMCF Plan Template. A guide for manufacturers and notified bodies avril-2020
MDCG 2020-8 Post-market clinical follow-up PMCF Evaluation Report Template. A guide for manufacturers and notified bodies avril-2020
MDCG 2020-10/1 Guidance on safety reporting in clinical investigations mai-2020
MDCG 2020-10/2 Appendix: Clinical investigation summary safety report form mai-2020
Applicability of clinical evaluation consultation procedure ??
Clinical evaluation assessment report template 2020*
Clinical investigation application 2020**
Clinical investigation assessment template 2020**
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**
MDCG-WG4 : Surveillance Après Commercialisation et Vigilance (PMSV)
Post-Market Surveillance requirements ??
Vigilance requirements ??
Development of harmonised reporting forms for incidents ??
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-2019
Update of PRRC (Person Responsible for Regulatory Compliance) document 2020
Authorised Representatives 2020
In-house manufacturers ??
Q&A on Custom-Made & Adaptable Devices* 2020*
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) 2020*
Classification of medical devices 2020*
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-2020
MDCG 2019-16 : Cybersecurity of Software janv-2020
Legal status of app providers* 2020*
Artificial Intelligence* under MDR/IVDR
framework of Software
2020**
MDCG-WG8 : Eudamed
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-WG9 : Identifiant unique du dispositif (UDI)
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
Integration of UDI in manufacturers’ QMS 2020*
Guidelines on specific product types (contact lenses) 2020*
Formats of AICD and HRI parts of UDI carriers** 2020**
List of values for certain data fields (clinical size + warnings and contraindications) 2020*
MDCG-WG10 : Questions internationales (INT)
Taking into account MDSAP for NB ??
MDCG-WG11 : Dispositifs médicaux de diagnostic in-vitro (IVD)
Classification of IVDs 2020*
Performance evaluation 2020*
SSP template and guidance ??
Transfer of CTS to CS 2020*
Development of common specifications ??
Qualification of assays used in clinical trials of medicinal products ??
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 2020*
Mapping CND-GMDN package T2 2020
Translation of EMDN ??
List of EMDN terms to be used for implant card purposes 2020*
MDCG-WG13 : Annexe XVI
Qualification of devices listed in Annex XVI ??
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
MDCG 2020-11 : Orientations sur le renouvellement de la désignation et la surveillance des organismes notifiés mai-20

Avancement des publications du MDCG

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

Fin extrapolée

Au rythme actuel, la fin des publications devrait arriver… vers septembre 2021.