Summary of the characteristics of a medical device
After medicines, it is now medical devices' turn to adopt the summary of the characteristics of a product.
From now on, when placing a medical device on the market, a summary of the main characteristics of the device must be established. This new obligation adds to, and does not replace, the preexisting obligatory declaration provided for by article L5211-4 of the public health code, and has been introduced in the context of a change in European standards. Indeed, French law has anticipated the forthcoming European Regulation concerning medical devices by making this summary of characteristics of medical devices obligatory, referred to as the “summary of safety and clinical performance” in the draft regulation.
The primary aim of this obligation is to introduce more transparence to the current system, by making public the principal elements of clinical data pertaining to a device. The regulation intends that this summary will give clear and easily accessible essential information to the users of the device.The regulation provides that in the future, the summary of medical devices must be made available to the public via the European Databank on medical devices (Eudamed). At the moment, only the European Commission and competent national authorities who have collected data themselves on medical devices, can consult the databank. Under the new regulation, the databank should become more open to the public, notably to firms in the health sector.
The summary of the characteristics of a device: what is it?
Establishing a summary of the characteristics of a device is a new obligation imposed on all manufacturers, or their representatives, of a new medical device placed on the market. The summary must be sent to the French National Agency for Medicines and Health Products (ANSM).A measure such as this already existed for medicines; pharmaceutical laboratories must submit a summary of their products’ characteristics to the ANSM, available online.
When does this obligation have to be executed?
The summary of the characteristics of medical devices is obligatory from 1st july 2017.
Which medical devices are concerned ?
In order to better protect the target users, only the more "dangerous" medical devices with a potential of higher risk will be subject to the communication of a summary of the characteristics of a medical device.Moreover, custom-made medical devices do not require this summary.Thus, are concerned:
implantable medical devices;
class III medical devices.
What is the procedure for transmitting the summary of the characteristics of a medical device ?
The summary of the characteristics of a medical device must be sent electronically to the chief executive of the ANSM during the commissioning of the medical device in France, at : communications.dm@ansm.sante.fr.The summary is sent in French or English via the form provided by the ANSM. In fact, as the form was established before the adoption of the law, it can seem more comprehensive than the provisions of the law themselves.Each trade name (the commercial name of the device) must be sent to the ANSM by the manufacturers, their representatives and the distributors who deliver the relevant devices to the user.
What must be included in the summary of characteristics of a medical device?
The content of the summary essentially contains the same elements as the application for CE marking:
1 – Identification number of the device, manufacturer and representative:
class and classification rules concerning the medical device;
Name, company name or trademark of the manufacturer, address of their headquarters and contact details;
Date of the summary of characteristics and its version number;
The unique device identifier (UDI) and unique registration number attributed by the manufacturer to the device in question, after the adoption of the forthcoming regulation.
2 – Use of the medical device:
Intended purpose of the device, including the Intended patient population, medical indications and contraindications;
Place of the device in diagnostic and therapeutic strategy;
Target users and their necessary training;
Residual risks, sides effects and precautions for use.
3 – Description of the medical device:
Working principle of the medical device, failing that, a reference to a previous generation of the device and a description of the modifications made;
Description of accessories, other medical devices and other products that are not medical devices, which are not intended to be used in combination with it;
Description or complete list of the various configurations/variants of the device that will be made available;
Reference to the relevant provisions of law.
4 – Clinical evaluation and post market surveillance:
Clinical evaluation report summary;
Information relative to the systematic procedure to proactively collect and review experience gained from the devices placed on the market.
What to do in the case of a change to the summary of the characteristics of a device over its lifetime ?
Any significant change made to an element found in the summary of the characteristics of the medical device must be immediately reported to the ANSM by the manufacturer, their representative or the distributors who distribute the medical devices directly to the user.
Public health code: article R. 5211-66-1 II
What are the risks of not submitting a summary of the characteristics of the medical device?
There are two types of sanction:
Criminal sanction of a 150 000 euro fine for medical device manufacturers or their representatives who do not submit their summary to the ANSM during the commissioning of the device in France. The fine is subject to being increased fivefold if the manufacturer or the representative is a company.
Administrative sanctions can be imposed by the ANSM for the same reasons as described above. The agency can add a daily fine to this sanction, which cannot exceed 2500 euros per day, when the party in breach has not complied with the requirements within a delay fixed by a formal notice. The agency can also publish the decisions imposing financial penalties.
Public health code: article L. 5461-6-1
Financial sanction
What will happen after the entry into force of the prospective regulation concerning medical devices?
The prospective regulation could push french legislators to adapt more than they currently do. Article 26 of the draft regulation provides the rules which are potentially applicable to the summary of characteristics of the medical device or the “summary of safety and clinical performance”.
According to these rules, the draft of this summary shall be submitted to the notified body and shall be validated by that body. After validation, the notified body shall upload this summary report to Eudamed and the manufacturer will have to mention on the label or instructions for use where the summary report is available. Undoubtedly, the manufacturer must therefore inform the users that the summary of the characteristics of the device will be accessible on the Eudamed and ANSM websites (if the latter decides to publish it).It is essential that you stay up to date with forthcoming requirements from the European Commission concerning the obligatory content of the summary of characteristics of the medical device.
This new reporting obligation of the characteristics of medical devices is not the only obligation weighing on manufacturers and their representatives during the market placement of a new device.This obligation is one of many reporting and communication obligations to be made to the ANSM, which will be elaborated in other blog articles.See our article on the unique device identification (UDI) of medical devices for more information.Our law firm is here to answer your questions on these matters: don't hesitate to get in touch!