Who is liable in Germany if a brain implant or connected medical device fails?

Patients need legal expenses cover, manufacturers need product liability cover. Guide figures from published premium examples in Germany.

An implant is a product. If a defect in the implant injures your body or health, the manufacturer must pay under section 1 of the Product Liability Act (Produkthaftungsgesetz), even if it was not at fault. You have to prove the defect, the damage and the link between them.

For implants placed on the market up to 8 December 2026, the current Act continues to apply. It caps liability for personal injury from the same defect at 85 million euros (section 10) and leaves you to bear the first 500 euros of property damage (section 11).

EU Directive 2024/2853 applies to products placed on the market after 9 December 2026. The Bundestag passed the German Act modernising product liability law on 8 October 2026. Software is then expressly a product, whether it runs inside the implant or comes from the cloud.

For people with a brain implant the key change is easier proof. If proving the defect or the causal link is excessively difficult because of technical or scientific complexity, it is enough to show that it is likely. The official explanatory notes name the innovative medical device as an example.

Medically recognised harm to mental health also counts as an injury, and the cap and the 500 euro own share disappear. Claims expire after ten years, or after 25 years for health damage with a long latency period.

With a connected medical device, such as an insulin pump with an app or an implant with a wireless link, the harm can come from a security flaw. Under the new law a product can be defective if it fails to meet relevant cybersecurity requirements.

If the manufacturer keeps control through updates, it is also liable for defects caused by an update and for missing security updates. Install approved updates and keep the manufacturer's notices, because they show what it knew.

Whoever fits or adjusts the implant is not liable for a device defect, but for their own mistakes in treatment and in explaining risks. German law helps you here too: under section 630h of the Civil Code (BGB), an error is presumed, for example, where a fully controllable treatment risk materialised.

At first it is often unclear whether the implant or the operation is to blame. Check claims against both sides and watch the deadline: claims under the Product Liability Act become time barred three years after you learn of the damage, the defect and the liable party.

Implants are medical devices under Regulation (EU) 2017/745, the MDR. Active implants and implants in direct contact with the central nervous system fall into the highest risk class III under Annex VIII, rule 8.

Under Article 10(16) MDR, manufacturers must have sufficient financial coverage for their liability, in proportion to the risk class and the size of the company. The MDR sets no fixed minimum sum. With most implants you also receive an implant card showing the manufacturer and serial number (Article 18).

There is no special insurance for failing implants for patients. Treatment runs through your health insurance as usual, and you claim compensation from the manufacturer or the doctor.

Private accident insurance (Unfallversicherung) rarely helps: the German model terms AUB 2020 exclude health damage from medical treatment or procedures on the body, unless the procedure followed an insured accident. Whether a later implant failure falls under this depends on your policy.

Legal expenses insurance (Rechtsschutzversicherung) with cover for damages claims is useful, because cases against implant makers need expert reports. It only covers disputes that arise after the start of the policy and any waiting period. Norman Nammert arranges suitable policies as an insurance broker.

You do not need your own liability cover for an implant. The risk of a device defect lies with the manufacturer, and the MDR requires it to make provision. If you already have legal expenses cover with a damages module, it also works for an implant claim.