French Public Health Code
In forceIn order to comply with the essential requirements relating to design and manufacture, medical devices, other than active implantable devices, must be designed, manufactured and packaged in such a way as to meet the following objectives:
1° To have chemical, physical and biological properties which enable them to guarantee the characteristics and performance referred to in Article R. 5211-21, to reduce as far as possible the risks presented by contaminants and residues for patients, staff involved in the transport, storage or use of the devices, to be used safely with any material with which they may normally come into contact or with the medicinal products which they are intended to administer, to reduce as far as possible the risks due to the substances which they release or to those which enter the devices unintentionally.
When a medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be 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, 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 risk-benefit ratio of its incorporation into the medical device.
Where a 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 upon the human body with 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 device.
2° Eliminate or reduce as far as possible the risk of infection or contamination for the patient, the user and third parties, by the selection of tissues or tissue-derived products of animal origin which may be used in the manufacture of devices and the methods chosen for the treatment and handling of these products during manufacture, as well as by the choice of manufacturing methods and packaging systems which make it possible, where appropriate, to ensure that sterility or any microbiological state specified by the manufacturer and indicated on the packaging or labelling is maintained under the intended conditions of storage and transport.
The authorised organisations keep information on the geographical origin of the animals whose tissues have been used.
3° Eliminate or reduce as far as possible the risks associated with their physical characteristics and ageing as well as those associated with foreseeable external influences;
4° Provide, for medical devices with a measurement function, sufficient accuracy and constancy of measurement taking into account their intended purpose and expressed in legal units;
5° Reduce the exposure of patients, users and third parties to emissions of radiation, whether intentional or not, to the minimum compatible with the intended purpose, without however restricting the application of doses indicated as appropriate for the precise therapeutic or diagnostic purposes sought and presenting benefits which outweigh the risks inherent in the emission, ensuring where possible that the characteristics and quantity of radiation emitted, particularly ionising radiation, can be controlled and regulated; these devices are equipped, where technically possible, with a device enabling the user to be informed of the quantity of radiation produced by the equipment during the radiological procedure;
6° Eliminate or reduce as far as possible the risks associated with medical devices connected to or equipped with an energy source, and in particular the electrical, mechanical or thermal risks, as well as the risks that the supply of energy or the administration of substances may present for the patient, and where possible, have a system for alerting and monitoring these risks;
7° Be accompanied by the necessary information to enable them 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 indications on the labelling and the information in the instruction leaflet.
