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MATERIOVIGILANCE (MEDICAL DEVICES) Any incident or risk
serious incident must be reported without delay to the AFSSAPS. Other adverse
events may be reported on a quarterly basis and optionally. Shall be regarded
as incident or risk of any incident serious incident or risk incident
involving a medical device caused or likely to cause death or serious
deterioration of the State of health of a patient, a user or a third party.
Examples: Death, vital prognosis, permanently or important incapacity,
hospitalization or prolongation of hospitalization, need for medical or
surgical intervention, congenital disease. A decision tree is
enclosed in page 2 of the CERFA reporting form formulaire
Cerfa n° 10246*02. Any person, manufacturer,
users, or third parties (persons who are manufacturers or users or patients,
the responsible for the placing on the market, distributors) with knowledge
of an incident or risk of serious incident must declare. The reporting is
carried out on the form "Reporting an incident or a risk of matériovigilance
incident. formulaire
Cerfa n° 10246*02 It is passed to the
AFSSAPS via either o
email : dedim.ugsv@afssaps.sante.fr o
fax au +33 (0)1.55.87.37.02, o
or mail 143/147 boulevard Anatole France, REACTOVIGILANCE (IN VITRO DIAGNOSTIC DEVICE) Any failure or
corruption of a medical diagnostic device in vitro which may cause adverse effects
on human health must be the subject of a declaration of réactovigilance
incident. In practice it is: indirect effect for the patient, from the
clinical consequences of a wrong analysis result, of a direct effect on user
due to a dangerous device In all cases, the
risk of incident must be reported in the same way as the proven incident.
Healthcare users a IVDD with misleading an adverse failure must report the
incident, that the IVDD is used in a laboratory for analysis (laboratory,
medical offices, pharmacies...). This reporting obligation lies also to the
industry (manufacturers, agents, distributors, importers) the incident
occurring at a user in France and/or in another European country if this
incident led to the establishment of specific measures (withdrawal of lots,
information / recommendation...) the declaration takes place without delay on
a specific form Download
the form - Donwload
the guidance to fill in the form The report is sent to
AFSSAPS either o
by fax : +33 (0)1.55.87.42.82 o
or by mail : DEDIM, département des vigilances, Unité de
réactovigilance 143-147 bd Anatole France 93285 Saint Denis Cedex FRANCE REGISTRATION
OF IIa, IIb, III et AIMD medical devices In its missions of surveillance of the market
of products placed on the market, the AFSSAPS analyzes communications
received under the Decree n° 2002-1221 September 30, 2002 and Decree n°2010-270 March 15, 2010 , Download
the Guidance , Download
the form Donwload
the FAQ REGISTRATION OF OTHER MEDICAL DEVICES Class I, kit, class I
with measuring function, sterile class I devices and custom-made devices Download
the manufacturer declaration , Download
EUDAMED Guidance , Fiche d'enregistrement
EUDAMED (06/10/2006) Download
EUDAMED Form REGISTRATION OF IN VITRO DIAGNOSTIC DEVICES Registration of
manufacturers and devices Guidance
, Download
Form A , Donwload
Form B , Donwload
Form C Clinical investigations
Regulatory texts
o
Public Health Law n° 2004-806 du
9 août 2004 (articles 88 à 97) du code de la santé publique. o
Program Law n°2006-450
dated April 18,
2006 for biomedical research (articles 31 - 33) o
Law n° 2005-1719 December 30, 2005 (article 153) o
Decree 2006-477 April 26, 2006, related
to Biomedical research o
Decree May 11, 2009 regarding the definitions of certain
categories of biomedical research o
Decree August 11, 2008 Conservation
by the sponsor and the investigator of the documents and data for a
biomedical research other than that relating to medicinal products for human
use. o
Decree March 9, 2007 content of the file to be sumbitted to
ethical comitee o
Decree August 24, 2006 fixing the
procedures for presentation and content demand of substantial modification of
a biomedical research involving a medical device or on a medical diagnostic
device in vitro to the French Agency of health and the protection of persons
Committee products safety o
Decree August 24, 2006 procedures
for reporting, the form and content of the safety of a biomedical research
report involving a medical device or on a in vitro diagnostic medical device.
o
Decree August 16, 2006 the
content, format and submission to French folder application biomedical health
products safety agency procedures with in vitro medical device or a medical
diagnostic device. o
Decree August 16, 2006 content,
format and procedures for presentation of the request for an opinion to the
Committee for protection of persons in biomedical research folder on the
medical device or on a medical diagnostic device in vitro. o
Decree August 16, 2006 the form,
content and modalities of adverse effects and new developments in biomedical
research statements relating to medical device or to a medical diagnostic
device in vitro. o
Decree August 16, 2006 concerning
the content and a biomedical research protocol submission procedures with in
vitro medical device or a medical diagnostic device. o
Decree August 16, 2006 content
and presentation of a brochure for the investigator of a biomedical research
with a medical device or a medical diagnostic device in vitro procedures. o
Decree April 25, 2006 maximum
indemnities as compensation for suffered constraints that a person may charge
for a year for its participation in biomedical. Forms and models
Beginning of the trial
o
Request permission
from the French Agency of health (Afssaps) and request for an opinion of the
Committee on protection of individuals (CPP) for biomedical research products
safety a medical device (14/11/2007) Download
o
Letter application
for authorization of biomedical research involving a medical device or a
medical diagnostic device in vitro of the French health products safety
agency (Afssaps) (14/11/2007) Download
Substantial Modifications
o
Form for request a
substantial modification notification of an In vitro diagnostic device
biomedical research (14/11/2007) Download o
Form for request a
substantial modification notification of a medical device or an In vitro
diagnostic device biomedical research (14/11/2007) (14/11/2007) Download
Vigilance
o
o
Vigilance report: additional information, follow-up data
(26/08/2009) Download Results
o
o
Form to declare the
end of biomedical research involving a medical device or medical diagnostic
device in vitro (14/11/2007) Download
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