SlideShare une entreprise Scribd logo
www.md101consulting.com
18 mars 2016 Hacking Health Camp 1
www.md101consulting.com
Homologation DM
• La réglementation – aperçu
• Start-up : appliquer la réglementation avec
succès
18 mars 2016 Hacking Health Camp 2
www.md101consulting.com
Quelques exemples
18 mars 2016 Hacking Health Camp 3
CMDCAS
PMDA
TGA
Equiv.
FDA ou CE
SFDA
www.md101consulting.com
Réglementation UE
• Directive 93/42 CE, dispositifs médicaux
• Nouveaux règlements en 2016 ou 2017
18 mars 2016 Hacking Health Camp 4
www.md101consulting.com
Classes (Niveaux de risque)
• 4 classes
– Classe I
– Classe IIa
– Classe IIb
– Classe III
• Critères techniques
18 mars 2016 Hacking Health Camp 5
www.md101consulting.com
Qualification - Classification
• Mon produit est-il DM ?
• Quelle est sa classe ?
18 mars 2016 Hacking Health Camp 6
www.md101consulting.com
Cas simples
• Mots-clés :
– Pathologie xyz …
– Diagnostic, Traitement …
18 mars 2016 Hacking Health Camp 7
www.md101consulting.com
Cas des DM frontières
• Smartphones – Tablettes
• Objets connectés
18 mars 2016 Hacking Health Camp 8
Envoi de données  Statistiques
www.md101consulting.com
Cas des DM frontières
• Smartphones – Tablettes
• Objets connectés
18 mars 2016 Hacking Health Camp 9
Envoi de données  Diagnostic
 Contrôle à distance
www.md101consulting.com
TIC – cas des DM frontières
18 mars 2016 Hacking Health Camp 10
Indication d’utilisation !
www.md101consulting.com
IMPACT POUR LES START-UP
18 mars 2016 Hacking Health Camp 11
www.md101consulting.com
Questions à se poser
D’abord et avant tout :
• Clients ?
• Besoins ?
• Marché ?
• Innovations ?
18 mars 2016 Hacking Health Camp 12
www.md101consulting.com
Questions à se poser
• Mon produit innovant est-il un dispositif
médical ?
18 mars 2016 Hacking Health Camp 13
OUI NON
Zone
d’incertitude
www.md101consulting.com
Questions à se poser
• Quelle est la classe de mon DM ?
• Classe “élevée” ?
• FDA ?
18 mars 2016 Hacking Health Camp 14
T0:
Classe I
T1:
Classe
IIa
T2:
Classe
IIb
www.md101consulting.com
Questions à se poser
• Mon produit pourrait-t-il être remboursé ?
– Oui  Valo +++
• Inclure dans le BP les activités et coûts
liés aux demandes de remboursement
18 mars 2016 Hacking Health Camp 15
www.md101consulting.com
Impact réglementation
• Quand commencer à se préoccuper de
réglementation ?
18 mars 2016 Hacking Health Camp 16
Idée
Prototype
Recherche
Conception, développementIndustrialisation
Activités de
Recherche
1er de série Prototype
Un peu en
fin de
Recherche
Surtout à
partir d’ici
www.md101consulting.com
En résumé
• La réglementation ne doit
pas être un frein
• Attention aux coûts
18 mars 2016 Hacking Health Camp 17
www.md101consulting.com
18 mars 2016 Hacking Health Camp 18
MERCI

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Hacking Health Camp 2016 - la réglementation des DM

Notes de l'éditeur

  1. 90/385 CE, dispositifs médicaux actifs implantables 93/42 CE, dispositifs médicaux 98/77 CE, diagnostic in vitro
  2. 18 règles basées sur propriétés du DM: Actif / non actif Temporaire / permanent Implantable / non implantable Stérile / non stérile Contient dérivés du sang Contient substances animales Utilisé conjointement avec médicament Guide: MEDDEV 2.4/1
  3. MDDS aux USA
  4.  Définition caractéristiques techniques du produit
  5. Si nécessaire demander à cabinet de conseil, voire autorité compétente Critères basés sur l’indication d’utilisation: 1. Diagnostic 2. Thérapeutique 3. Accessoire d’un autre DM
  6. MEDDEV 2.4/1 Manual on Borderline classification Classe “élevée” ? Sur tous les marchés ? Sur un marché (USA) ? Par rapport aux produits concurrents ?  Revoir si nécessaire les caractéristiques du produit, la cible marché …
  7. Etudes cliniques Comités scientifiques, sociétés savantes Cabinets de conseil Temps très long des procédures administratives http://www.ispor.org/HTARoadMaps/Default.asp
  8. Sauf si les coûts liés à la réglementation explosent par rapport aux revenus attendus