M&A in the medical device sector

27/10/2021


Article published on globallawexperts.com


On 26 May 2021 EU Reg. 2017/745 became fully effective and applicable.  With this Regulation, many freely available software products now become medical devices or, if they already are, increase their risk class. These aspects must be taken into account in Merge & Acquisition transactions because they could have a significant impact on the value of the company (e.g. start-ups).

Let's take a closer look at the legal framework.

The MDR has broadened the notion of 'accessory' (Art. 1(2)). (art. 1 lett. 2): as a consequence, many software used in healthcare will now have to be included in the scope of application of the MDR.

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