Capitalizing on the experience of its partners in health authorities, laboratories and firms dedicated to the health industries, ELSI has developed a sharp expertise and a recognized practice on regulatory issues and problems, in their economic, commercial and competitive context.
Member of the DM Experts network, the firm is anchored in a very pragmatic approach to the DM and IVD sector, apprehending the technical specificities in their regulatory framework and being able to provide a global and complete expertise to its clients, whatever their size. This is why our law firm, which specialises in medical device law, also assists or represents its clients, both French and foreign, in their dealings with the authorities and the registration of their devices in the LPPR.
ELSI's lawyers are members of a Comité de Protection des Personnes (CPP), which gives them a constant link with the practice and the new issues of the sector. They are also involved in all matters relating to the regulation of clinical investigations and assist sponsors and investigators in their dealings with the authorities.
Thanks to its strong experience in the healthcare industry, ELSI also advises on business law for the development, negotiation, implementation and protection of commercial, distribution and advertising policies throughout the product life cycle.
The law on medical devices has undergone profound changes since the entry into force and application of the Regulations on medical devices and IVDs, which replace Directives 93/42/EEC, 98/79/EC and 90/385/EEC.
Theextension of the scope of the regulations to devices that were previously unregulated or poorly regulated, such as devices intended to be used for disease prognosis purposes, DMs manufactured using derivatives of human tissues or cells, or DMs without medical purpose listed in Annex XVI, as well as the change in classification rules, in particular for software or products incorporating nanomaterials, implying major changes in the conditions for accessing the market for these products and obtaining CE markings, are all new issues and questions that operators must face and adapt to and may need a lawyer specialising in medical device law.
The applicability of these new texts also marks a significant strengthening and clarification of the responsibilities of DM and IVD operators at each stage of the life cycle of their products: designation of a person responsible for ensuring compliance with the regulations (PCR), increased requirements in terms of clinical evidence(strengthening of the clinical evaluation, obligations to carry out clinical investigations for certain high-risk DMs), improvement of the post-market surveillance system, including vigilance and the obligation to communicate periodic safety reports (PSUR).
Boosting the whole health products sector, the reinforcement of transparency and traceability mark this reform by the implementation of the European database EUDAMED and a Unique Device Identifier (UDI) for all DM.
These impacts also affect the very functioning of control and surveillance bodies, notified bodies and competent authorities, such as the ANSM, whose obligations and responsibilities have been reinforced.
By reinforcing the demonstration of product safety, clinical evaluation, traceability and post-marketing surveillance, and the competences of the control and surveillance authorities, the new regulations entail major changes in the organisations of DM operators, whether they are manufacturers, agents, importers, distributors or other players. This is why ELSI offers its clients a complete support in strategy and security of all processes related to the marketing of DM & IVD throughout their life cycle.
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Medical device law
An amendment to the WDR has just been proposed by the European Commission to postpone the entry into force of the WDR.