Probiotic Medical Devices lose their market

06/15/2022
Diapharm

Diapharm manages switch to medicinal product

As the Medical Device Regulation (MDR) enters into force, medical devices containing probiotic ingredients fall within the scope of the Medicinal Products Directive (MPD).

In order to keep such products on the market they ought to be transformed into medicinal products in good time. This is a complex task and time is scarce.

Selling off the products in question – under the transition rule pursuant to Article 120 MDR - is burdened by ambiguities.
Currently, the guideline of the CAMD (Competent Authority for Medical Devices) produces enormous uncertainties as it puts the applicability of Article 120 MDR in question when probiotics are concerned.

In March 2019, Diapharm has obtained a judgement of the Administrative Court in Schleswig that says that, in Germany, Article 120 MDR applies to all medical devices with valid MDD certificates.
Other member states, however, continue to go by the CAMD Guideline, with serious consequences for the market. For example, in the summer of 2021, Greece ordered a total recall of such medicinal products.

Switching from a medical device to a medicinal product, successfully and efficiently, is a challenge. Taking regulatory and time-dependent imponderabilities into account demands exact knowledge and comprehensive experience with such processes.

Diapharm has already obtained the marketing authorization in Germany for a former probiotic medical device as a medicinal product.
By way of the mutual recognition procedure (MRP), national authorisations may be applied for in other member states as well.

Do you have any questions?
Call us and you will find out how the switch of your product can be accomplished.

+49 251 60935 - 0

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