French Public Health Code
In forceIn order to comply with the essential requirements relating to design and manufacture, active implantable medical devices must be designed, manufactured and packaged in such a way as to meet the following objectives:
1° to remain sterile, under the conditions of transport and storage provided for by the manufacturer, from the time they are placed on the market until the packaging, which may not be reused, is opened with a view to implantation ;
2° Eliminate or reduce as far as possible the risks linked to their physical characteristics, to the use of energy sources and in particular electricity, to foreseeable external influences, to medical or surgical interventions, to ionising radiation from radioactive substances forming part of the device, as well as the risks linked in particular to a malfunction or ageing of the device provided that maintenance or calibration is not possible;
3° Have properties making it possible to guarantee the characteristics and performances mentioned in Article R. 5211-21, in particular as regards the reliability of the device control systems and the compatibility of the materials used with body tissues, cells and fluids, taking into account the intended use of the devices, or with the substances intended to be administered by the devices;
4° Ensure, where an active implantable medical device incorporates as an integral part a substance which, if used separately, is likely to be considered as a medicinal product, with the exception of medicinal products derived from blood, and which may act on the human body by an action ancillary to that of the device, that the quality, safety and usefulness of this substance are verified using the appropriate methods set out in articles R. 5121-10 to R. 5121-20.
After verifying the usefulness of incorporating the substance into the medical device, taking into account the intended purpose of the device, the authorised body asks the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), one of the competent medicines authorities designated by the other Member States of the European Union or parties to the Agreement on the European Economic Area, or the European Medicines Agency for a scientific opinion on the quality and safety of the substance, and in particular on the balance between the benefits and risks of incorporating it into the medical device.
Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, is liable to be regarded as a medicinal product derived from blood and which may act on the human body through action ancillary to that of the device, the authorised body, after verifying the usefulness of incorporating the substance into the medical device, taking into account the intended purpose of the device, shall request a scientific opinion from the European Medicines Agency on the quality and safety of this substance, and in particular on the benefit/risk balance of its incorporation into the medical device.
5° Be able to be identified, as well as their components, where applicable, in such a way as to make any appropriate action necessary following the discovery of a potential risk linked to the devices or components;
6° Include a code enabling the device and manufacturer to be identified, which can be consulted, if necessary, without the need for surgical intervention;
7° Ensure that any instructions given on the device to ensure its correct operation are understandable to the user and, where appropriate, the patient;
8° Be accompanied by the necessary information to enable it to be used correctly and safely, taking into account the training and knowledge of potential users, and to identify the manufacturer. This information includes the particulars shown on the packaging ensuring the sterility of the device and those shown on the commercial packaging.
