Many thanks to Sylvie Poulette, expert on medical devices themes, for writing this article and sharing her knowledge with readers.
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Clinical research has become essential for medical device companies. How to go about it to mount his clinical investigation? What are the specific characteristics, texts and reference guides to be considered?
Since Decree No. 2010-270 of 15 March 2010 making the Directive 2007/47 EC enforceable in French law, clinical research has become a must for medical devices (MDs) French manufacturers.
A clinical study (clinical investigation for MDs) is compulsory on the CE Mark approval of some of MDs whose categories and conditions are specified by the directive 2007/47 EC and all MDs are subjected to an obligation clinical data provision after their access to the market. Upcoming European regulations on medical devices also plan to strengthen the clinical evaluation of DM throughout their life cycle, the introduction of clinical performance evidence for in vitro diagnostic MDs and supervision of clinical investigations.
In addition to these requirements, access to reimbursement requires, under certain conditions defined by the HAS (French National Authority for Health), provision of clinical evidence according to well defined criteria and methodologies that should be anticipated in the construction of its study.
How to go about it to mount his clinical investigation? What are the specific characteristics, texts and reference guides to be considered?
Unlike drugs, no phase I, II, III for MD marketing. For many (low risk) MDs, a single pre-marketing study is conducted. The manufacturer must, in that case, prove a risk and performance assessment based on a risk analysis, previous studies on the device and the procedure related to its implementation. For a real therapeutic innovation and / or MD at risk, a first pilot trial on human will establish proof of medical and scientific concept and evaluate the safety of MD. The target population must be carefully selected to demonstrate an acceptable benefit / risk waited. The ANSM (French Competent Authority) suggests pre-submission for advice before submission for studies on MD at risk. This process is carried out at the manufacturer’s initiative. All procedures, information on clinical trials of MDs are available on the ANSM website.
Three types of clinical researches exist for MDs, including two interventional:
– Biomedical research (BMR) and Research in routine care (RRC) in French: recherche en soins courants (RSC). If a BMR is essential for an innovative MD or new indication, a RRC is suitable for a marketed MD. The MD must be used under the usual practice; however randomization and special monitoring arrangements are possible provided that the risks associated with such procedures remain low.
The observational study excludes any additional or unusual procedure of diagnostic or monitoring and therefore randomization. The risks of expedient that may affect the results relevance are accordingly higher in this last type of study. To limit these risks, particular importance should be given to the statistical methodology and a register should be considered for use.
– The clinical investigation should meet the final objectives defined according to the device, its stage of development, regulatory requirements related to its CE marking, when appropriate, access to reimbursement, and will rely on the guides and appropriated recommendations. The guides of MEDDEV (2.7 / 4 and 2.7 / 2), the standard EN ISO 14155 and practical and methodological guides of HAS specified the guidelines and recommendations on pre- and post-marketing clinical investigations. To access the repayment or renewal, guides to applying for registration and post-registration studies are available on the HAS website.
Finally, because of the recency of the MD clinical investigation obligation, recruitment of experienced investigators in clinical research is sometimes difficult. A feasibility study on sites is particularly important and will, in case of identified needs, implement appropriate solutions in the concerned centers (provision of clinical research staff, including appropriate information to the investigators) for the best conditions of a study management.
Sylvie Poulette resume:
Dr. in Biological and Medical Sciences, Sylvie Poulette was recipient of research at INSERM, attached to higher education and teacher in science, biotechnology and quality management in bio industries.
From 2008, she completed training in clinical research and worked as clinical research associate. In charge of projects designing and development, she has also provided their methodological and scientific management to their added-value.
Since 1st October 2012, she assists companies in biotechnology and medical devices companies in their clinical projects development products and / or applications development in the health sector.
Throughout her career, Sylvie Poulette has developed specific skills that enable a project comprehensive approach to every products development stage in any medical field.
To learn more about Sylvie Poulette, you can visit Sylvie’s LinkedIn profile here.
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