The French Heath Product safety agency (AFSSaPS) has published a notice (in english) for sponsors for clinical investigations regarding medical devices and in vitro diagnostic medical devices which explains the new process for clinical investigation.
Download it here: http://afssaps.sante.fr/htm/5/essclin/dm/avis_promoteurs_essais_clinic_dm_english.pdf
In vitro diagnostic medical device: definition according to European community
In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients,
or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.
Medical Device: definition according to European community
Medical Device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
The main French Medical Agencies
AFSSaPS (French health products safety agency) is the French Regulatory authority, the competent authority for all safety decisions taken concerning health products from their manufacturing to their marketing, i.e:
HAS (French National Authority for Health) is in charge to provide health authorities with the information needed to make decisions on the reimbursement of medical products and services.
To be reimbursed, medical devices has to be include, by HAS, on the National Health insurance list = LPPR (List of products and services reimbursable).
LPPR include :
- drugs and raw materials;
- medical devices and in vitro diagnosis devices;
- labile blood products or other biological products of human or animal origin (organs, tissues, cells), gene or cell therapy products, ancillary therapeutic products;
- products used for the upkeep or application of contact lenses, insecticides or similar products for human use, biocides;
- cosmetic products, tattooing products, etc.
HAS (French National Authority for Health) is in charge to provide health authorities with the information needed to make decisions on the reimbursement of medical products and services.
To be reimbursed, medical devices has to be include, by HAS, on the National Health insurance list = LPPR (List of products and services reimbursable).
LPPR include :
- Medical devices for individual use.
- Human tissue and cell and derived.
- Health products other than drugs.
- Associated services.
CLADIMED
CLADIMED is the name of
- A five levels classification for medical devices and
- A non-profit association to manage the classification.
Classification principles:
- Devices are divided into different families (12), according to
- the organ or system on which they act
- their main use
- validated indications.
- A device can only be located in one location
- Modifications of the classification are made when new groups are required or if the actual classification is not adapted, according to users or suppliers.
- Modifications are agreed by the scientific committee and are submitted to manufacturers and users for comments or objections.
- Modifications are included in the classification once a year, in December.
CLADIMED association is managed by a board of directors including permanent members and elected members.
- Permanent members
- ACL (Manufacturer association for codification)
- AP-HP (First hospital group in
- APPAMED (Manufacturer association)
- CNIHM (hospital pharmacist association)
- EUROPHARMAT (hospital pharmacist and manufacturers association)
- SNITEM (Manufacturer association)
- SNPHPU (hospital pharmacist trade union)
- SYNPREPH (hospital pharmacist trade union)
- Elected members are
- Corporate members
- B.BRAUN
- BECTON
- COLOPLAST
- Hospices Civils de Lyon (Second hospital group in
- Individual members (hospital pharmacist)
A scientific committee is in charge to guarantee evolution quality process.
CLADIMED web site http://cladimed.site.voila.fr/
MODE OF APPLICATION TO THE FRENCH PUBLIC TENDERS
When a French Administration wants to select a supplier, it publishes an “Invitation to tender” so that all the concerned suppliers are allowed to make an offer.
In addition to the publication, the administration published documents “ the tender schedule of conditions” which describe candidacy submission, the answer procedure, the lots description, the forecasted quantity, the order and invoicing policy, the penalty policy, the answer deadline, etc.
All those documents are available only in French language.
To answer, the candidates must fill-in a list of administrative forms relative to the financial situation, the nationality, the resources, references and qualification.
The administrative forms to fill-in are:
- Application letter (DC4 Form.)
- Contract (DC8 Form)
- Candidate notification (DC5 Form)
All those document must be written in French as well as the certificates joined. If they are not in French, a certified as a true translation must be joined.
The person who signs the documents must be authorized. A delegation of signatures is necessary for those who are not authorized.
Hereunder is the list of certificates to be joined :
- The candidate is not under interdiction to apply public tenders or any equivalent rules for non French candidates.
- The candidate is not bankrupt (or the subject of proceedings for a declaration of bankruptcy), is not beeing wound up, has not suspended business activities or his/her affairs are not being administrated by the court.
- The candidate has not been convicted of any offence concerning his/her professional conduct.
- The candidate has not been guilty of grave professional misconduct (e.g. miserepresentation).
- The candidate has paid social security contributions or taxes.
The candidate must also join a bank account number where the payments should be made, and a blank model of invoice showing that the registred Company name and address is similar to the administrative forms.
The French disposable Medical Devices
From a strategical point of view, a company which decides to develop a Medical devices business in Europe can’t ignore the French market : the French total Medical Devices market is the second european market (behind Germany) and is estimated at 9.6 Billion $ in 2003 with a market growth of 4.5% per year.
The French disposable Medical Devices is estimated at 2.5 billion $. 50% of this business comes from Public Hospitals submitted to the French Public Tender Code. Entering in this business requires to fully understand the tender procedure. It is a specialized job in France because it is a heavy, complicated task and a job that demands painstaking attention to detail.
To be successful in the French hospital tenders requires to follow some Golden rules :
- To operate in the field several months before the invitation to tender publication : It is necessary to built a relationship with the different actors in the hospital, : purchaser, doctors, nurses, and to analyze the competitive environment.
This rule is of major importance to get the tender. - To read the tender publications (BOAMP, JOUE, local newspapers, Websites).
- To answer within the tender deadline.
- To strictly follow the answer procedure described.
- To know the French Public Tender Code and changes occuring.
In order to make all those tasks efficient and unexpensive, we have developed services called : Intelligence of Public Tenders (IPT).
Those services are based on powerful softwares mixed with our 20 years of expertise in French Public Hospitals Tenders both sides : Public Hospitals and Suppliers.
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