Section 5: Essential health and safety requirements.

Medical devices must be designed and manufactured, taking into account the generally recognised state of the art, in such a way that, when used in accordance with their intended purpose and under the conditions laid down for that purpose, they do not compromise, directly or indirectly: 1° the clinical condition and safety of patients ; 2° The health and safety of users or other persons; 3° the safety of property….

In 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…

In 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…

Medical devices and active implantable medical devices manufactured from non-viable tissues of animal origin or non-viable products derived from tissues of animal origin, falling within the scope defined in paragraphs 2 and 4 of Article 1 of Commission Regulation (EU) No 722/2012 of 8 August 2012 on specific requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC for active implantable medical devices and medical devices manufactured…

Before applying for the issue of the EC design examination certificate or EC type examination certificate referred to in Articles R. 5211-40 and R. 5211-41 respectively, manufacturers of medical devices or active implantable medical devices referred to in Article R. 5211-23-1, or their authorised representatives, shall define and implement a risk analysis and management system guaranteeing a high level of protection for patients and users. The risk analysis and management…

The manufacturer is required to update the risk analysis and management system referred to in Article R. 5211-23-2 by analysing all elements relating to the medical devices he manufactures and taking account of public information relating to similar medical devices. This analysis shall specify, in particular, whether a new risk has been detected, whether the level of a risk has changed or become unacceptable, or whether the initial assessment is…

The conditions for implementing the essential requirements defined in this section are specified, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health.