Beyond Discontinuation - Legal Duties at Device End of Life

Understanding Manufacturer Responsibilities after Discontinuing a Medical Device or IVD

Cécile van der Heijden, Attorney-at-law, Axon Lawyers

The decision to discontinue a medical device or IVD commercially does not necessarily mean that it has reached the end of its life in the market.

[Download a Practical Guide to Device & IVD Post-Market Surveillance, Vigilance & Reporting]

Manufacturers must assess which obligations persist beyond commercial discontinuation and continue to comply with the MDR or IVDR for devices still in use or in the supply chain. In other words, a strategic end-of-life plan is essential. 

This should cover contractual relationships, internal systems, external obligations, and formal notifications. Liability insurances and similar risk-mitigation measures should also be reviewed.

Discontinuation of market placement does not end a manufacturer’s responsibilities. Vigilance reporting, post-market surveillance, post-market clinical follow-up and liability for products remain in force. 

Clear communication with device users and patients about termination of device-related services and support is crucial. Contracts must be reviewed to determine ongoing obligations related to warranties, availability of spare parts and maintenance obligations. 

Corrective and preventive maintenance, in particular, can have a direct impact on availability of capital equipment and potentially patient safety if withdrawn prematurely.

Under both the MDR and IVDR, manufacturers must retain the technical documentation and declaration of conformity for at least 10 years after the last device has been placed on the market.

“Corrective and preventive maintenance, in particular, can have a direct impact on availability of capital equipment and potentially patient safety if withdrawn prematurely.”

Similar retention obligations apply to clinical study data. Such obligations become especially relevant if discontinuation coincides with the manufacturer’s bankruptcy, liquidation, or corporate restructuring.

Finally, where discontinuation of supply may pose a serious risk to patients or public health in a member state, Articles 10a MDR and 10a IVDR impose mandatory notification requirements. These include timely communication to national competent authorities, healthcare providers, institutions, and relevant economic operators.

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Cécile van der Heijden is a data protection specialist and legal advisor at the intersection of healthcare, life sciences, and data protection. Her work focuses on AI in healthcare, data compliance, cybersecurity, clinical trials, and market access for medicinal products and medical devices.

A frequent speaker at international conferences, she shares insights on medical devices, privacy laws, and EU regulatory developments.