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NEW
AFSSAPS "List of regulatory positions and
qualifications" now
includes a table of contents, and is split into two chapters: i. issues relating to the regulatory procedures II.
Issues relating to the status or the class of a product last updated:
September 23, 2011 (Available only in French) Download ROHS directive: The Council conducted on May 27, 2011 the revision
of the directive on hazardous substances in electrical and electronic
equipment. Now, the protection against hazardous chemicals is extended to
more electrical appliances. Legislation, originally adopted in 2003,
prohibits the use of six hazardous substances (including lead, mercury and
cadmium) in electrical and electronic equipment. In the revised legislation,
the prohibition is extended to many more products
and it is harmonized throughout the EU: ban apply now, in principle, to all
electrical and electronic equipment as well as cables and spare parts.
However certain transition periods are planned: three years for medical
devices and control and monitoring instruments, six years and five years for
in vitro diagnostic medical devices and six years for industrial control
equipment. DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 8 June 2011 on the restriction of
the use of certain hazardous substances in electrical and electronic equipment (recast) Download European Community: Manual on borderline and classification in the community regulatory framework
for medical devices Version 1.10 August 2011 Download FRANCE AFSSAPS Communication
of IIa, IIb, III class
medical devices and AIMDD Communication Form for placing medical
devices into service (in conformity with french law articles L.5211-4,
R.5211-66) Form last updated May 2011 Download Notice last updated July 2011 Download European Medical Device Usability
Requirements (EN 62366) Manufacturers marketing medical devices in Europe
need to be able to demonstrate compliance with the newly clarified usability
requirements introduced by Directive 2007/47/EC. EUROPE Directive “Recast” The EU Commission has completed
(September 2011) the Impact Assessment of the medical devices directive
revision, which is a prerequisite. All EU Commission sources indicate the
draft Regulation is expected to be published in April or May 2012. At that
time, the Impact Assessment will also be released. It is believed that the
draft text will include within its scope the following previously
unregulated: products with non-viable human tissue or cells, aesthetic
products, in-house laboratory test, genetic tests with a diagnostic purpose.
Additionally, a decision about reprocessing single use devices is expected.
The Commission is also considering enhanced engagement of Competent Authority
post-marketing safety through central reporting of incidents by manufacturers
and more consistent review and assessment of vigilance. To address
long-standing issues of inconsistency among Notified Bodies, it was suggested
that increased oversight of Notified Bodies is needed by stipulating minimum
requirements as well as more consistent designation and monitoring, perhaps
by a European group. For the administrative, technical, and support entity,
the EU Commission presented two possible candidates for a centralized agency,
a group within the European Medicines Agency (EMA) or within the Joint
Research Centre (JRC).(Source EMERGO) European Commission publishes draft regulation on electronic
instructions for use of medical devices on June 2011 Download USA FDA
Medical Device Pre-Market Programs: An
Overview of FDA Actions - Executive
Summary October 2011 Download IEC / 60601‐1 and
related standards: the third edition of the standard IEC
/ in 60601‐1 presents a genuine evolution in the
approach based on risk analysis as in its application by certification
bodies. The third edition of the standard IEC / in 60601‐1 allows the manufacturer to define
the acceptable level of risk, while respecting the general requirements for
basic safety. Further reference is made now to the operator environment. The
general standard in this family, EN 60601-1, currently has two versions
published which are based on the "2nd Edition" and "3rd
Edition" of IEC 60601-1. At the present time, both the "2nd
Edition" and "3rd Edition" are harmonized against the Medical
Devices Directive (MDD) and therefore provide a presumption of conformity with
the relevant Essential Requirements (Annex I of the MDD). However, EN 60601-1
"2nd Edition" loses its harmonized status with the MDD on June 1,
2012, so this will no longer offer this presumption of conformity or be
considered the state of the art. Harmonized standards for Medical Devices (last update 19 August 2011)
Download Archives
HARMONIZED STANDARD FOR MEDICAL DEVICES Last Update July 14, 2010
EUDAMED European Commission
Decision of 19 April 2010 on the European Databank
on Medical Devices (Eudamed) Download FRANCE TRANSPOSES THE DIRECTIVE ON MEDICAL DEVICES
AND PUBLISHES THE DECREES OF APPLICATION Decree of March 15, 2010 amending the
Decree of April, 20 2006 related to the rules for classification of medical
devices, under article R. 5211-7 of the French code of public health Download Decree of March 15, 2010 related to
the conditions of implementation of the essential requirements for medical
devices under article R. 5211-24 of the French code of public health Download Decree of March 15, 2010 related to
the procedures of conformity certification as defined in article R. 5211-39
to R. 5211-52 under article R. 5211-53 of the French code of public health Télécharger Class IIa, IIb, III and AIMD medical devices: New modalities of registration for FRANCE
(French only). Decree n° 2010-270
(march 15, 2010) related to the clinical evaluation of medical devices and
communications of data to the French agency for the sanitary security of
health product (AFSSAPS) Download Decree Download AFSSAPS Guideline
FAQ Download Help form REIMBURSEMENT OF MEDICAL DEVICES IN FRANCE (French only) Declaration of “LPP” codes Decree n° 2010-247 (mach 10, 2010)
and new modality of registration Download the
Decree, FAQ , LPP declaration guidance CLINICAL EVALUATION Publication of the revised version of MEDDEV 2.1.7
“Clinical evaluation” Download CLINICAL INVESTIGATIONS IN FRANCE: New modalities of declaration (French
decrees February 2009) To access the forms REACH Registration, Evaluation, Authorisation and Restriction of Chemical substances.
REACH is a new
European Community Regulation on chemicals and their safe use (EC
1907/2006). It deals with the Registration,
Evaluation, Authorisation and Restriction of
Chemical substances. The new law entered into force on 1 June 2007.
The aim of REACH is to improve the protection of
human health and the environment through the better and earlier
identification of the intrinsic properties of chemical substances. At the
same time, innovative capability and competitiveness of the EU chemicals
industry should be enhanced. The benefits of the REACH system will come
gradually, as more and more substances are phased into REACH. The REACH Regulation gives greater responsibility to
industry to manage the risks from chemicals and to provide safety information
on the substances. Manufacturers and importers will be required to gather
information on the properties of their chemical substances, which will allow
their safe handling, and to register the information in a central database
run by the European Chemicals Agency (ECHA) in
Helsinki. The Agency will act as the central point in the REACH system: it
will manage the databases necessary to operate the system, co-ordinate the
in-depth evaluation of suspicious chemicals and run a public database in
which consumers and professionals can find hazard information. The Regulation also calls for the progressive
substitution of the most dangerous chemicals when suitable alternatives have
been identified. For more information read: REACH in Brief. REACH provisions will be phased-in over 11 years.
Companies can find explanations of REACH in the guidance documents and can address themselves to a number
of helpdesks. RECAST OF THE MEDICAL DEVICES DIRECTIVES Public CONSULTATION The Commission is considering a revision
of the legal framework in Europe for Medical Devices in order to improve and
strengthen this framework and to meet the growing expectations of European citizens.
In line with the Commission’s policy on consultation, the Commission has
prepared a public consultation in the form of a questionnaire in
which stakeholders are invited to comment on the main issues DIR 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5
September 2007 amending Council Directive 90/385/EEC on the approximation of
the laws of the Member States relating to active implantable medical devices,
Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC
concerning the placing of biocidal products on the
market Download Dir 2007/47
Download consolidated version of
Dir 93/42 Publication of Directive
2007/47/CE of the European Parliament and of the Council of 5 September 2007
amending Council Directive 90/385/EEC on the approximation of the laws of the
Member States relating to active implantable medical devices, Council
Directive 93/42/EEC concerning medical devices and Directive 98/8/EC
concerning the placing of biocidal products on the
market Download Reinforcement of the surveillance
of Medical devices
with a high potential of risks for human
health FRANCE AFSSAPS
June 2007 Download FRANCE AFSSAPS November 2007 Free sale
certificate for medical devices – Procedure and guidance Download REGULATION OF MEDICAL DEVICES OF ANIMAL ORIGIN IN French Decree of December 4, 2006 modifying the
decree of September 13, 2005 relating to the detailed specifications
specifying the essential requirements to which must conform the medical
devices manufactured using animal origin tissue Download PUBLICATIONS
OF THE FRENCH DECREES RELATING TO BIOMEDICAL RESEARCH Decree of August 16, 2006 fixing the contents,
the format and methods of presentation at the French Agency of medical safety
of the products of health (AFSSAPS) of request for authorization of
biomedical research relating on a medical device or a medical device of in
vitro diagnostic device Download Decree of August 16, 2006 fixing the
contents, the format and methods of presentation of the request for opinion
at the committee of protection of the people on a biomedical research project
relating on a medical device or a in vitro diagnostic device Download Decree of August 16, 2006 relating to
the contents and the methods of presentation of a protocol of biomedical
research relating on a medical device or a
in vitro diagnostic device
Download Decree of August 16, 2006 relating to
the contents and the methods of presentation of a booklet for the
investigator of a biomedical research relating on a medical device or or a in vitro
diagnostic device Download Decree of August 25, 2006 fixing the scale and the
methods of covering of the tax and the additional fee envisaged at the
article L. 1123-8 of the code of the public health Download GOOD MANUFACTURING PRACTICE Decision of May 26, 2006 modifying the decree of
modified May 10, 1995 relating to good manufacturing practice Download BIOMEDICAL
RESEARCH IN FRANCE Decree
n° 2006-477 of April 26, 2006 relating to biomedical research Download decree
Download modified text REVISION OF EC 93/42 DIRECTIVE A public web Consultation on the Proposal was closed
on the 25/06/2005. The text of the Proposal (Download) and a summary report on the responses to the
consultation is now available Download.
REGULATION OF MEDICAL DEVICES OF ANIMAL ORIGIN IN The
regulation governing the clearance of the medical devices of animal origin
has been just supplemented. The evaluation of the viral risk and spongiform encephalopathies transmission realized in a systematic
way by the AFSSAPS in transferred to DEDIM and does not necessitate any more
the establishment of lists of medical devices having received a favorable
opinion as for viral safety. REVISION HURIET’S LAW - ¨PHASE CONTROLS WHILE
WAITING FOR THE PUBLICATION OF THE DECREES OF APPLICATION (SOURCE AFSSAPS) Within the framework of the transposition in
national law directive 2001/20/EC relating to the clinical trials, certain
legislative provisions were modified in In preparation with the effective application of the
legislative provisions and decrees, transitional measures are proposed by
AFSSAPS allowing thus all the promoters who wish it, to carry out the
clinical trials of medical devices according to methods' close to those
envisaged by these provisions. The purpose of this pilot phase by simulating
the future phase of authorization is essential to check on the one hand, if
the contents of the files to be subjected are adapted and applicable to the
various situations starting from the gained experience and, in addition, to
check the feasibility of the system of a first evaluation within 30 maximum
day. The new legislative and lawful framework of
biomedical research relating to the medical devices the phase controls Download Information and procedures concerning the phase
controls evaluation of clinical trials of medical devices Download List documents required by AFSSAPS for a request for
evaluation of a clinical trial of medical device within the framework of the
Pilot phase simulating a request for authorization of clinical trial of
medical device according to methods' envisaged by the law relating to the
policy of public health and its decrees of application .Download 2005/50/EC DIRECTIVE of 11 August 2005 on the reclassification of hip,
knee and shoulder joint replacements in the framework of Council Directive
93/42/EEC concerning medical devices Download
PROPOSAL FOR A DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL AMENDING COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993
CONCERNING MEDICAL DEVICES In line with the Communication presented to the
Council and Parliament in the summer of 2003 the Commission services, together
with stakeholders, has prepared an early draft text to amend the Medical
Devices Directive 93/42/EEC. This text is now available for public
comment. For this purpose we attach a text highlighting the
changes as they would appear in the current text of Directive 93/42/EEC. Download
CONTRIBUTION ON THE EXPENDITURE OF PROMOTION OF THE
MEDICAL DEVICES IN Decree of November 15, 2005 fixing the model of the
form "contribution on the expenditure of promotion of the medical
devices" Download
Guidance Download
, Form of declaration and payment Download CLINICAL TRIAL IN The transformation of the consultative committees of
protection of the people involved in biomedical research (CCPPRB) into
committees of protection of people (CPP) pursuant to the law of August 9,
2004 French General Inspection of the Social Affairs Download
ISO 9000:2005 « QUALITY MANAGEMENT SYSTEMS -
FUNDAMENTALS AND VOCABULARY » UPDATED ON OCTOBER 2005. The ISO published a new edition of the standard which,
in the ISO 9000 family, defines the vocabulary and describes the essential
principles of the systems of management of quality. Several definitions were
added and explanatory notes were enriched or added to take into account more
recent documents of the ISO 9000 family. MEDICAL DEVICES WITH A HIGH POTENTIAL OF RISKS FOR
HUMAN HEALTH-DIRECTIONS FOR USE : FORM UPDATE (april/2005) More
information General information Access
the form MODIFICATION OF THE REIMBURSEMENT OF SOME MEDICAL
DEVICES IN Source: French Ministry for Health May 2005. The
setting of pricing to the activity envisages two methods of assumptions of
reimbursement of the medical devices and drugs: by refunding of a total fixed
price including the whole of the acts and by products used. The drugs and
medical devices taken in charges by insurance at fixed prices are
automatically erased from the list of refundable products (LPP) in order to avoid
a double refunding. CLINICAL INVESTIGATION: REVISION OF THE FRENCH LAW
(HURIET’S LAW BY AUGUST 9, 2004) Download Because of obligation of transposition of the European directive 2001/20/EC relating to the clinical trials of drugs (Dowload The
principal modifications are: *
a widening of the field of application *
Responsibility for the promoter *
Reinforcement of the protection of the patient
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