New update obligation for medical devices made from or with software Medical devices
For example, the new EU Directive 2019/771 "on certain aspects of the sale of goods ..." ("Sale of Goods Directive") contains for the first time an explicit obligation to provide consumers with software updates after a sale has been made and to inform them of their availability. Previously, the product only had to be free of defects at the time of the transfer of risk; there were no general, subsequent "update obligations". The update obligation applies to security updates and all other updates that are "necessary to maintain the conformity of the goods with the contract". Unfortunately, there is no clear specification for the end date of such an update obligation. In the case of simple sales contracts, the obligation applies for as long as the consumer can "reasonably expect" updates. In any case, this will include the warranty period.
The above applies to medical devices that consist of hardware and contain software. For software-only medical devices, however, EU Directive 2019/770 "on certain aspects of contract law relating to the supply of digital content ..." ("Digital Content Directive"). However, medical devices that are prescribed or provided by a healthcare professional are to be excluded from the scope of the Digital Content Directive. Conversely, the Digital Content Directive should apply if consumers can purchase the software medical device independently. In terms of content, almost identical requirements apply to software updates under the Digital Content Directive.
As these are EU directives, they must be transposed into national law by the individual member states by July 2021. It is therefore to be expected that the German sales law in the German Civil Code (BGB) will have to be adapted, which must come into force nationally from January 2022 at the latest. Both directives contain numerous requirements that go beyond the mere obligation to update. As the deadlines are comparatively short, the new requirements should already be taken into account in product development and marketing strategy.
Various details of the new regulations are expected to be clarified in the first half of 2021, e.g. the exact delimitation of the two directives, as well as the question of how and to what extent sellers of products with digital content now have to "keep records" of their buyers in order to be able to fulfill their information obligation with regard to updates.
This article is taken from our brochure Potentials MedTech 2021.