French Public Health Code
In forceBefore 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 system, defined by the manufacturer for each medical device, evaluates the latter according to criteria relating to the need to use tissues or products derived from animal origin, the selection of starting materials, the application of a production process allowing the inactivation or elimination of infectious agents of transmissible spongiform encephalopathies, the establishment of a system for collecting and evaluating information, acquired during the production and post-production phases, concerning changes which may have consequences for the conformity assessment, as well as the characteristics of the medical device and its intended use. These criteria are specified in point 1 of Annex I to 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 utilising tissues of animal origin.
The risk analysis and management system shall also take account of the published opinions of the competent European or international scientific committees and bodies. It shall include an analysis of any relevant evidence relating to transmissible spongiform encephalopathies. It identifies the hazards and assesses the risks presented by the animal tissues or derived products in question. It gathers all relevant documentation on the measures taken to minimise the risk of transmission. It assesses the residual risk associated with the device using the tissues or derived products in question, taking into account the intended use, the expected clinical benefit and the available alternatives.
For custom-made devices and devices intended for clinical investigations covered by Article R. 5211-23-1, the declaration by the manufacturer or his authorised representative and the documentation referred to in Articles R. 5211-51 and R. 5211-38 respectively shall also cover compliance with the specific requirements defined in section 1 of Annex I to the aforementioned Regulation (EU) No 722/2012.
