Lille 2 university, Europharmat, former Afssaps and SNITEM released in 2012 a new interactive e-learning module about MD's regulatory.
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The new approach
The new approach (recently revised and now called the New Legislative Framework or NLF) is a unique legislative framework for the marketing in Europe of a broad range of consumer products. It defines essential requirements to be reached so as to guarantee consumer safety without however judging in advance the technical solutions needed to achieve that.
The new approach directives apply to a wide range of products and more than 24 sector-based directives have been developed. The products that comply with this framework bear CE marking which is the visible sign that the products conform to all the applicable legislation regarding safety.
CE marking guarantees free circulation of safe products within the European Union.
The European directives (Directive 93/42EEC for medical devices and Directive 90/385 for active implantable medical devices) set the mandatory essential requirements which aim to guarantee the safety and health of the public. To achieve these outcome objectives, those responsible for marketing products (manufacturers) can follow specifications that are defined according to standards called «harmonised standards». The list of these applicable standards for the directives in question is published in the Official Journal of the European Union. Compliance with these standards when marketing a product gives manufacturers a «presumption of conformity».
The basic principles of CE marking are as follows:
- Manufacturers' responsibility
- Certification by a third party
- Examination afterwards by the competent authorities
In France, the competent authority for regulations and market surveillance is the ANSM. It comes into play, after the event, to monitor the market, that is to say to make sure that any devices marketed in France comply with health and safety requirements. This surveillance is carried out in three ways:
- By assessing any incidents or risks of incidents it has been notified of within the context of medical device vigilance and reactive vigilance,
- Further to the communication carried out as part of bringing certain devices into service in France, which manufacturers have to abide by,
- By any assessment action that Afssaps carries out on its own initiative concerning any devices whose conformity with the above-mentioned essential requirements for health and safety need to be made sure of.
In addition to these missions, ANSM is also in charge of authorising clinical investigations involving medical devices conducted in France. It is moreover tasked with the accreditation of bodies responsible for evaluating the conformity of medical devices with the essential requirements and also the approval of bodies responsible for carrying out quality control, which certain medical devices are subject to. Lastly, ANSM has the power to take appropriate policing measures when there is a danger for public health.