The new regulation 2017/745 on medical devices was adopted on spring 2017, replacing the existing directives. A transitional period is ongoing to May 2020, date of the implementation.
According to the European Commission, this new text “establishes a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.” Three axes are highlighted, the improvement of: the quality and safety, the transparency of consumers information and the enhancement of vigilance and market surveillance. Indeed, the willingness is to secure the market by an increase of the requirements throughout the life of the devices.
IMPACT IN NUTRITION FIELD?
Nutrition field is concerned since medical devices can be substances; as long as the product answers to the definition of medical device (in particular the effect must be purely physical/mechanical as opposed to pharmacological, physiological, or immunological). These products can be very similar to food supplements (aspects, conditions of use…) but, as they are not considered as food they are not subject to the Nutrition and Health Claims Regulation (No 1924/2006).
However, classification’s rules, proof for clinical evaluation and product regulatory category will be surrounded more strictly with the new regulation. Indeed, in the continuity of the prohibition of cranberry-based product in medical devices, some currently marketed substance-based medical devices will potentially be re-classified in higher class of risk, or, be transferred into a new product category, most likely food supplement, with then, impact on allowed health claims.
Another category of product had less chance: the live microorganisms, explicitly mentioned as no longer being acceptable as medical devices after 2020. Dead microorganisms might still be accepted, but those do not meet the probiotic definition anymore.
CLINICAL INVESTIGATIONS STRONGLY RECOMMENDED
Regarding the clinical evaluation, equivalence principle and literature data used alone will be more difficult to use to bring proof of safety and performance of the device, whereas clinical trials are strongly recommended.
Reinforcement of the rules on clinical evidence will lead to an increase of clinical trials in order to collect new data before and after CE marking. For example, clinical trials become mandatory for class III and implantable. Reinforcement of the criteria for designation and processes for oversight of Notified Bodies will also occurred, with consequences potential stricter rules for marketing authorization (higher requirements levels).
Revisions of guidance are attended over the next few years to be in accordance with the new Regulation. In particular, the MEDDEV’s recommendation for clinical evaluation is really expected.
Biofortis supports you to design your future studies according regulation requirements.
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