- In brief: Liability to patients damaged by defective medical devices (Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH)
- Original news
- What was this case about?
- What did the Advocate General opine?
- What should IP & IT lawyers take note of?
IP&IT analysis: Notified bodies under the Medical Devices Directive 93/42/EEC, may be liable to patients and users of medical devices for a culpable failure to fulfil their obligations resulting from EU product safety rules. Thus, an auditor responsible for assessing the compliance of a medical device manufacturing system may be liable to patients who suffer damage as a result of defects in the audited products.
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