Dr. Manuela Reinhold

Medicinal product or (substance-based) medical device?

By Dr. Manuela Reinhold October 4, 2023 Leave a comment

The classification of whether a device is a medicinal product or a substance-based medical device has far-reaching regulatory consequences. This classification is so demanding that there are regular disputes with authorities and notified bodies, and in 2023, even the European Court of Justice had to rule on the matter. This article helps manufacturers, authorities, and…

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Distributor requirements (that also affect the manufacturers)

By Dr. Manuela Reinhold October 22, 2021 2 Comments

The medical device regulations have significantly increased the requirements for distributors. You need to understand these requirements to avoid multi-year custodial sentences threatened in the event of infringement. This article also considers extensive guidance issued by the Irish regulator. 1. What a “distributor” is (and what it isn’t) a) Definition The Medical Device Regulation (MDR) has many…

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