Innovative solution for the healthcare
Thanks to a valuable pool of experts, Mérieux NutriSciences supports you in the development of the testing plan to determine which studies are necessary to ensure that the device is safe and effective, meeting the essential requirements for affixing the CE mark on the product.
The new Regulation 745/2017 defined as Medical Device any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products are also considered Medical Devices:
- devices for the control or support of conception,
- products specifically intended for the cleaning, disinfection or sterilisation of devices.
Medical Devices Classification
For a correct classification of Medical Devices, it is advisable to check the intended use and the mechanism of action. Medical Devices are classified into risk classes according to duration, mode and type of interaction with the body:
- CLASS I (including Is & Im): all non-invasive devices with some exceptions for surgical instruments and for invasive devices related to body orifices - lower risk
- CLASS II (including IIa and IIb): invasive devices related to body orifices and invasive surgical nature, and devices based on substances
- CLASS III: invasive surgical devices and devices based on substances
Thanks to the continuous research and innovation of a department dedicated to medical devices, Mérieux NutriSciences aims to promote all the possible options to in vivo testing in favour of a solid in vitro approach.
The 3R principle
The purpose of this approach is to reduce or replace animal testing wherever possible:
- REPLEACEMENT of the animal model with in vitro models
- REDUCTION in the number of animals used in trials while maintaining the same level of information, where it is not possible to replace the animal model
- REFINEMENT of the suffering level imposed by actively improving the quality of life of the animal during the experimental procedures
Our most common tests and services
All our Tests and Services
Mérieux NutriSciences offers a complete portfolio of GxP-compliant studies and laboratory analyses useful for the release of raw materials and finished pharmaceutical products, as required as part of the drug manufacturing, development and commercialization process.
Mérieux NutriSciences offers a complete portfolio of GxP-compliant studies and laboratory analyses to ensure the safety of active pharmaceutical ingredients (APIs), excipients, finished products and medical devices.
Sequence of activities in order to demonstrate and provide documentary evidence that a specific product can be reliably manufactured via the processes in question (thus, it is closely related to substance quality).
We can support your new compound or innovative food product by generating scientific evidence through randomized clinical trials.
Stability testing provides evidence of how the quality of an active pharmaceutical ingredient (API), medicinal product or medical device varies over time. This approach also takes into account the influence of a variety of environmental factors, such as temperature, humidity and light.