The “intra-GHS” system, introduced in article L. 165-11 of the social security code by the law of 29 December 2011 on strengthening the health safety of medicines and health products, conditions the purchase, the supply and use of certain medical devices by healthcare establishments, and their reimbursement as hospitalization services, upon inclusion on a list, known as “intra-GHS”.
As part of the renewal of registration of EPIC, EPIC mitrale, EPIC SUPRA, TRIFECTA and TRIFECTA GT devices registered on the intra-GHS positive list and in accordance with the provisions of Article R. 165-56 of the Social Security Code, the duration of registration of these MDs is extended by a period corresponding to the duration of suspension of instruction for request for additional information.
The EPIC, EPIC mitrale, EPIC SUPRA, TRIFECTA and TRIFECTA GT devices therefore remain registered on the intra-GHS positive list, pending the opinion of the HAS and the decision relating to their registration renewal and those up to ‘on the end date of registration mentioned in the list for each DM concerned.
Registration on the intra-GHS list of conventional implantable cardiac defibrillators with endocavitary lead (single, double and triple chamber) is extended until April 22, 2023 pending the upcoming evaluation of this category of devices by HAS .
Device recall
The medical devices concerned by the “intra-GHS” system belong to homogeneous categories of health products determined by orders of the ministers responsible for health and social security. These categories of medical devices are determined with regard to their invasiveness or the risks that they may present to human health.
In order to be included on the “intra-GHS” list, medical devices must first be assessed by the National Commission for the Assessment of Medical Devices and Health Technologies (CNEDiMTS) of the High Authority of health (HAS).
Medical devices must demonstrate at least one of the following requirements: validation of the clinical efficacy of the devices, definition of specific technical specifications or assessment of their efficiency with regard to the therapeutic alternatives available.
This assessment thus makes it possible, in areas where the risks and issues for patients are major, to strengthen the obligation to produce clinical data, beyond those provided in support of the CE marking application, in the aim of supporting the relevance of their use and their management, in the context of French care.
On the basis of the opinion issued by the CNEDiMTS following its assessment, the ministers responsible for health and social security take the decision to register (by an order published in the Official Journal) or not the medical devices on the the “intra-GHS” list. Beyond the deadline set by the decree setting the homogeneous categories, the medical devices concerned must be registered on this positive list in order to continue to be able to be purchased and used by health establishments and to be covered under the benefits of hospitalization.
The registration of the MDs concerned on the “intra-GHS” list is carried out in the form of a brand name or a generic line according to the procedures determined for each homogeneous category of MD.
The “intra-GHS” system is regulated in the social security code in articles L. 165-11 and R. 165-49 to R.165-62.
Framework for the use of medical devices belonging to one of the homogeneous categories of the intra-GHS list in the context of research involving the human person
Insofar as the devices are not covered under hospitalization services, health establishments may, in the context of research involving the human person covered by title II of book I of the first part of the health code public to supply and use medical devices belonging to the homogeneous categories of devices and which are not registered on the so-called “intra-GHS” list.
Homogeneous categories retained for 2013
conventional implantable cardiac defibrillators with endocavitary lead (single, double and triple chamber);
implantable cardiac defibrillators without endocavitary lead;
intracranial stents used in the angioplasty of atheromatous stenoses;
biological surgical heart valves with suture
sutureless biological surgical heart valves
Homogeneous categories defined for 2019
The order of February 22, 2019, amended successively by the decrees of November 26, 2019 and May 28, 2020, of September 23, 2020 a you February 20, 2021 has defined 5 new homogeneous categories of medical devices:
implantable devices intended for the vaginal treatment of pelvic organ prolapse;
implantable devices intended for the vaginal treatment of urinary incontinence;
devices intended for the upper treatment of pelvic organ prolapse;
intracranial stents for flow diversion;
thrombectomy devices, including stent retrievers, thrombo-aspiration systems as well as thrombectomy-specific balloon guiding catheters.
The transitional period provided for by order before the entry into application of the intra-GHS list for these different categories has ended.
Under these conditions, only devices registered on the “intra-GHS” list for these categories can therefore be purchased and used by healthcare establishments.
However, it should be noted that in certain specific cases, devices belonging to these categories may be registered and supported under the list in addition, when an application for registration of this type has been submitted and the devices also meet the eligibility conditions thereof.
The diagram below lists the 10 homogeneous categories of medical devices concerned by the “intra-GHS” system.
Publication of the Intra-GHS list
After the publication of the registration orders, the consolidated “intra-GHS” list is made accessible on this page and is updated as new orders are published.
Recommendations for manufacturers
Article R. 165-55 of the Social Security Code provides that “decisions relating to the inclusion or modification of the conditions of inclusion of a product on the list provided for in I of Article L. 165 -11 are published in the Official Journal. They are taken and communicated within a period of one hundred and eighty days from receipt of the request.
This 180-day period corresponds to the time necessary for the High Authority for Health to assess the devices and for the competent ministers to take the decision whether or not to include them on the “intra-GHS” list.
Therefore, for each new homogeneous category provided for by decree, the ministries responsible for health and social security and the High Authority for Health recommend that manufacturers submit their application files no later than 180 days before the end of the transitional period. planned, in order to avoid any disruption of care, or even of access to care for the patient.
Procedures for filing files
For any application for registration, renewal or modification of registration on the intra-GHS list, the entire file must be submitted to the CNEDiMTS in a dematerialized manner as indicated on the HAS website. A copy of the entire file must be sent to the Ministry of Health at the address: [email protected]
You will mention a single correspondent who will be the sole recipient and interlocutor of exchanges with HAS and the Ministry of Health throughout the examination of the file.
The diagram below summarizes the steps for inclusion on the “intra-GHS” list of a medical device.
Real-life monitoring of intra-GHS medical devices
Article L.162-17-1-2 of the Social Security Code provides in particular that the management of medical devices registered on the intra-GHS list may be subject to the collection and transmission of information relating to their real life uses. The use of the unique device identifier (UID), introduced by European regulation 2017/745 relating to medical devices, makes it possible to ensure this collection and transmission of information by healthcare establishments.
In this context, a repository of UDI-IDs (device identifier specific to a manufacturer and a device) of the different models and commercial references of the devices currently registered on the “intra-GHS” list is made available to healthcare establishments.
This reference is available here: IUD-ID repository of intra-GHS medical devices (December 23, 2022)
This repository is updated with each new registration, modification of registration or removal of medical devices from the “intra-GHS” list.
In this context and in order to keep this reference system up to date, the IUD-ID must now be entered in the application file for registration on the intra-GHS list for any new request or modification of registration (for example: addition reference).
Source
General Directorate of Health
Sub-Directorate for Health Products Policy and Quality of Practices and Care
Bureau of Medical Devices and Other Health Products
14, avenue Duquesne – 75350 PARIS 07 SP
Email: [email protected]
