HomeNewsTowards a certification of the medical device Sales teams

Towards a certification of the medical device Sales teams

16/10/2018

 
Decree No. 2018-864 was published on October 8, 2018. It follows the law on social security (LFSS 2018) which specified the obligations of the HAS (High Health Authority). One of them is the creation of a charter leading to the certification of medical device Sales teams. This decree thus specifies the elaboration of a future law related to the practices of presentation, information or promotion in favor of the products of health and the possibly associated services. This measure is comparable to what has already been done in the drug where medical visitors are subject to a "good practice" charter..

This decree thus specifies the elaboration of a future law related to the practices of presentation, information or promotion in favor of the products of health and the possibly associated services. 
This measure is comparable to what has already been done in the drug where medical visitors are subject to a "good practice" charter
 
 
The drafting of this charter targets manufacturers and distributors of DM with at least one LPP product (list of products and services reimbursable by the Health Insurance). The HAS wishes by this measure to control the unjustified expenses for the health insurance.

It will be concluded between the Economic Committee on Health Prices (CEPS) and the representatives of the manufacturers and / or distributors concerned. In the event that no agreement is reached, the government will stop this measure.


 
Certification, which will assess compliance with the charter, will be provided by the French Accreditation Committee or a member organization of the European Cooperation for Accreditation under the responsibility of the HAS. The companies concerned will be notified of their audit at least one month in advance and this certification, once obtained, will have a maximum validity of three years. In the case of non-compliance with these objectives, the companies will be sanctioned financially (10% of the turnover generated in France maximum).
 
We can imagine that this charter, the content of which is not yet fixed, will most probably force the manufacturers of medical devices to train and evaluate its medical visitors as is practiced in pharmaceutical laboratories.
 
📅 The charter will be defined during 2019 then a period of 1 year is expected for its implementation and publication in the Official Journal.
 

 

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