Medical Devices – Deadlock on Rule 21 broken
On May 25, at the 10th Trialogue, a final agreement was reached on the long-awaited Medical Device legislation. A “risk-based approach” has been applied, with the result that substance-based medical devices will be in Class III, the highest risk class, if they achieve their intended purpose in the stomach or lower intestinal tract. Also, nasal sprays and other devices whose intended purpose is achieved in the nasal or oral cavities will now be put in Class IIa. The new Medical Device legislation is expected to come into force in January 2020.
a&r comments: This means that all substance-based medical devices for topical or nasal application will be considered Class IIa, while products with an intended purpose in the stomach or lower gastrointestinal tract become class III, if they or their metabolites, are systematically absorbed. For all the others, which have only a physical interaction within the GI-tract will be considered class IIb. Class I is no longer accessible to substance-based medical devices. Manufacturers of these products would be faced with considerable work and expenses for additional data on efficacy and quality when launching these products if this version of the new legislation came into force.
EFSA has rejected a health claim on DHA and memory function
The health claim application, submitted by DSM Nutritional Products, was rejected due to very conflicting data, with the majority of submitted studies not showing any effect. Only two submitted studies show a beneficial effect of DHA supplementation on memory function.
a&r comments: This health claim rejection demonstrates the importance of submitting health claim applications only when the majority of submitted clinical trials have a positive outcome when substantiating the claimed effect.