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04 September 2019
The EU Medical Device Regulation (2017/745) (MDR) was introduced in May 2017 and sets out the legal framework for medical devices in Germany. The MDR repeals the EU Active Implantable Medical Devices Directive (90/385/EEC) and the EU Medical Device Directive (93/42/EEC) and will fully apply from May 2020.
In contrast to the original proposal for the MDR (see COM(2012) 542 (final version)), the MDR stipulates that any natural or legal person may claim compensation for damages caused by a defective medical device in accordance with applicable EU and national laws (Article 10(16) of the MDR).
To safeguard against potential liability claims under the EU Product Liability Directive (85/374/EEC), medical device manufacturers must have measures in place to provide sufficient financial coverage (Article 10(16) of the MDR).
However, as medical software can hardly be considered a 'product' under the German Act on Product Liability and the EU Product Liability Directive, it is conceivable that no liability applies under the respective provisions and, therefore, there is no need for financial coverage (for further information please see "MDR and medical software: liability under German law").
However, German medical software manufacturers should nevertheless have sufficient financial coverage in place in light of:
The MDR requires financial coverage to be proportionate to a medical software manufacturer's size, the risk class of the products and the product types (Article 10(16) MDR). The rationale behind this requirement is comprehensible: larger companies can generally shoulder significant financial coverage costs, higher classes carry higher risks and innovative products often carry unpredictable risks. However, the actual implementation for the practice remains unclear. This especially applies in cases where major manufacturers place small numbers of products on the market or where products are technically complex without being innovative.
However, the MDR provides no further guidance on:
In light of the new regime, affected groups such as authorities, manufacturers and insurers are encouraged to develop practicable solutions. As a start, manufacturers should document all considerations made in the context of financial coverage – including sales numbers, sales territories, expected product lifetimes and the distribution of intra-company responsibilities – and retain this documentation in case it is required by the competent authority.
For further information on this topic please contact Fabian Huber or Caroline von Nussbaum at Simmons & Simmons LLP by telephone (+49 2 11 4 70 53 0) or email (email@example.com or caroline.vonnussbaum@Simmons-Simmons.com). The Simmons & Simmons LLP website can be accessed at www.simmons-simmons.com.
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