The new European regulation relating to medical devices (MD), in force since May 2021, does not ban MDs that resemble medicinal products but lack marketing authorisation (MA). However, it formally identifies these MDs and stipulates additional requirements. Fewer MDs will be able to be marketed under the sole responsibility of their manufacturers. A new rule should result in more MDs composed exclusively of chemical substances being assigned to class III, the class most tightly regulated by the certifying, so-called "notified" bodies. The scientific opinion of a health products agency will be required for some MDs, which will perhaps call into question their certification, and hence their marketing. The regulation aims to strengthen requirements relating to clinical evaluation and introduces obligations for MDs in class III. The regulation reinforces the use of a centralised database specific to MDs, EUDAMED, which will be a step forward, so long as public access to the clinical data in it is guaranteed. Regarding safety, there is provision for post-marketing surveillance by the manufacturer.

This potential progress will be influenced by the extent to which the rules are applied by manufacturers. Respect of the rules will also depend on the ability of the notified bodies to monitor the work of manufacturers and the health authorities' ability to supervise an overcrowded market, made all the more difficult because the regulations still allow major shortcomings to persist, including lack of transparency regarding compositions, and the nearly total absence of publicly available evaluation data and of any framework governing advertising and health claims.

The ball is now in the health authorities' court, but in the interest of protecting patients, it is better to use health care products for which conclusive clinical data are available.

©Prescrire 1 November 2021

Source: "Medical devices that resemble medicines: benefits for industry, uncertainties for patients" Prescrire International 2021; 30 (231): 274-275. Subscribers only.

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