A defective medical device can cause a new injury, worsen a medical condition or make a second surgery necessary. If you are facing this situation, you might wonder whether the manufacturer, the healthcare facility, the doctor or multiple parties together should be held liable. You might also have doubts regarding the value of a recall, the preservation of the removed device and the time available to take action.
In this guide I want to help you distinguish a product defect from a clinical complication and from an error in use or maintenance. I will explain which liabilities may come into play, what needs to be proven, what damages can be compensated and why the time limits change depending on the party against whom the claim is brought.
When a medical device is legally defective
A defect does not coincide with every negative outcome of treatment. Articles 114 et seq. of the Consumer Code govern liability for damage caused by defective products. In particular, Article 117 considers a product defective when it does not provide the safety that a person is entitled to expect, taking all circumstances into account. The text of the regulation can be consulted in the Consumer Code on Normattiva.
The expected safety also depends on how the device is presented. Instructions, warnings, reasonably foreseeable use and the time the product was put into circulation all matter. A device does not become defective simply because a safer or technologically more advanced one is subsequently marketed.
The problem can arise at different stages. The design may expose users to an abnormal risk; a single unit may be manufactured differently from the others; the instructions may omit a relevant hazard. For devices equipped with digital components, the software, updates and measures necessary to keep the operation secure may also become important.
A known complication does not automatically rule out the defect, nor does it prove it. A prosthesis may deteriorate due to a material defect, wear and tear compatible with its lifespan, incorrect positioning or individual biological conditions. Similarly, the CE mark and formal compliance with instructions are relevant elements, but they alone do not conclude the assessment of the product's actual safety.
Devices belonging to a risky series
For certain implantable devices, the legitimately expected safety is particularly high. In joined cases C-503/13 and C-504/13, concerning pacemakers and implantable cardioverter-defibrillators, the Court of Justice recognized that a potential defect found in the same group or series can make it possible to classify the individual product as defective without waiting for it to fail. The principle is illustrated in the Court of Justice judgment of 5 March 2015.
This is not a presumption valid for every device. The conclusion depended on the life-saving function of the devices, the vulnerability of the patients and the potentially very serious consequences of a failure. For another product, it is therefore necessary to verify its nature, the reported risk, its series membership and the reasonably enforceable level of safety.
Who may be liable for the damage
The manufacturer is liable without the injured party having to prove fault. This does not mean that compensation is automatic: whoever brings the claim must prove the defect, the damage and the causal link. The manufacturer may also invoke the exclusion grounds provided for by Article 118 of the Consumer Code, proving the facts on which its defense is based.
Manufacturer does not only mean the final maker. The rules may also apply to the component manufacturer, anyone who puts their name or trademark on the device, and the importer into the European Union of a product from a third country. When these parties are not identifiable, the supplier can be involved under the conditions of Article 116, unless they inform the injured party within the statutory timeframe of the identity of the manufacturer or the person who supplied them with the product.
The identification of the device is therefore essential. Model, serial number, batch, manufacturer and importer make it possible to trace the supply chain and check whether a safety notice concerns that exact product. For an implant, this data may appear in the identification card, medical record, operating theater register and labels applied to health documents.
The position of the healthcare facility
The facility does not become a manufacturer simply because it uses the device. Product liability and liability relating to healthcare services follow different legal bases. The Court of Justice has clarified that the liability of a healthcare provider using a product manufactured by others does not fall, as such, within the scope of European rules on product liability, without prejudice to the possibility for national law to regulate the position of the facility. The principle is set out in judgment C-495/10.
In Italy, Article 7 of Law No. 24 of March 8, 2017 establishes that public or private healthcare or social-healthcare facilities are liable under contractual liability rules for the intentional or negligent conduct of the professionals they rely on. The regulation is published in Law No. 24 of 2017 in the Official Gazette.
For the facility, the choice, use and management of the device matter. Equipment inadequate for the service provided, incorrect installation, insufficient sterilization, omitted maintenance, use contrary to instructions or failure to respond to a safety notice may all be relevant. Conversely, the mere presence of an original and unrecognisable defect does not automatically identify a breach of contract by the facility.
Manufacturer and facility may be liable for concurrent causes. The former may have put an unsafe product into circulation; the latter may have increased the risk by storing it improperly or continuing to use it despite a relevant notice. To understand liability, it is necessary to separate what happens in design and manufacturing from what happens during selection, implantation, use and monitoring.
The position of the individual healthcare professional
The mere use of the device does not prove medical negligence. A healthcare professional working within a facility is normally liable pursuant to Article 2043 of the Civil Code, unless they have directly assumed a contractual obligation towards the patient. It is necessary to identify negligent, imprudent or technically inadequate conduct and prove that it caused or aggravated the damage.
What the claimant must prove
Against the manufacturer, three elements must be proven: damage, defect and causal link. Article 120 of the Consumer Code places these elements upon the injured party. Therefore, it is not enough to prove that the device broke or stopped working; the malfunction must be traced back to a lack of safety and it must be explained how it produced the claimed injury.
Proof may derive from multiple concurring clues. Identifying data of the device, medical reports before and after the event, diagnostic images, manufacturer instructions, safety communications and technical assessments can all be relevant. A recall strengthens the reconstruction only if it includes the model or batch concerned and points out the exact same risk that actually materialized.
The preservation of the removed device can be decisive. A technical examination can ascertain breakage, deformations, contamination, wear and alterations of components. When clinical conditions permit, it is useful to request in writing that the product be identified and kept in such a way as not to compromise its analysis, without interfering with the therapeutic and organizational needs of the intervention.
If the device is no longer available, the claim does not necessarily become impossible, but the assessment may be more difficult. Photographs, the explantation report, radiological examinations, macroscopic description, batch data and manufacturer communications can still provide useful elements. However, the lack of the product cannot be filled with mere guesswork.
In a claim against the facility, the subject matter of proof changes. The patient must prove the healthcare relationship, the damage and the connection with the alleged breach. The facility can prove that it performed the service correctly or that the outcome depends on a cause not attributable to it. A manufacturing defect therefore requires different assessments compared to inadequate installation or maintenance.
Medico-legal and technical evaluations perform complementary functions. The former reconstructs the health consequences; the latter analyzes the device. A breakage alone does not explain the clinical damage, just as a deterioration in health does not automatically prove that the product was defective.
What damages can be compensated
Injury to health constitutes the main damage. Temporary and permanent consequences on psychophysical integrity, suffering related to the impairment and limitations concretely produced in daily life can all be considered. Compensation depends on the nature, duration and severity of the consequences, not solely on the finding that the device was unsafe.
Documented financial losses may be added. The assessment includes expenses necessary for visits, hospital stays, rehabilitation, assistance, medication and potential replacement of the device, in addition to causally linked loss of earnings. Future expenses require a reasonable clinical prediction and cannot be based on purely hypothetical costs.
In cases concerning pacemakers and implantable cardioverter-defibrillators, the Court of Justice considered the costs of replacement surgery to be compensable when the intervention was necessary to eliminate the defect. The medical necessity of the procedure remains decisive: the existence of a warning does not automatically make any intervention decided without an adequate clinical basis compensable.
The Consumer Code also covers the deterioration or destruction of any item of property other than the defective product itself, provided this property is of a type normally intended for private use and was used by the injured person mainly for private use. Article 123 provides a threshold of 387 euros for this damage to property. This threshold does not concern personal injury and does not govern the cost of the defective product itself, for which different contractual remedies may apply.
The mere fear of a future failure does not automatically entail compensation. A different situation arises when the risk makes additional checks, limitations, therapies or an intervention necessary. These consequences must also be proven and linked to the defect or the challenged conduct.
Statute of limitations and ten-year limit against the manufacturer
The special action against the manufacturer is subject to a three-year limitation period. Article 125 of the Consumer Code runs this period from the day the injured person had, or should have had, knowledge of the damage, the defect and the identity of the person liable. Therefore, the date of implantation, the first symptom and the diagnosis may not coincide.
It is not necessary to wait for complete procedural certainty before the limitation period begins to run. The assessment concerns the moment when the available elements reasonably allow the damage to be linked to the potential defect and the responsible party to be identified. For damages that emerge slowly, this reconstruction requires particular caution.
There is also a ten-year limit from the date the product was put into circulation. Article 126 extinguishes the right provided by the special discipline if judicial proceedings are not brought against the manufacturer or the equivalent party within this period. A formal out-of-court notice can affect the three-year limitation period, but it must not be confused with the judicial action required to prevent the expiry of the ten-year limit.
For the healthcare facility, contractual liability is normally subject to the ordinary ten-year limitation period. For the individual healthcare professional who is liable pursuant to Article 2043, the term is generally five years, without prejudice to statutory exceptions. Time limits must be reconstructed separately for each responsible party, even when the damage is the same.
Transition to the new European framework
The date the product was placed on the market remains decisive. Directive (EU) 2024/2853 establishes that the new provisions apply to products placed on the market or put into service after December 8, 2026. For prior products, the regime deriving from the previous directive continues to apply, as stated in Articles 2 and 21 of the European directive on liability for defective products.
As of the reference date of September 17, 2026, rules designed for subsequent products should therefore not be applied in advance to devices already placed on the market. The transition concerns the individual product, not simply the day the damage is discovered or the lawsuit is filed.
Compensation claims and paths to consider
The first choice consists in identifying the possible cause of the damage. An original defect points the claim toward the manufacturer; an installation, usage or maintenance error may involve the facility; inadequate healthcare conduct may take on independent relevance. Claims can be brought together, but they must maintain distinct legal grounds and evidence.
A useful dispute identifies the device, describes the damage, indicates the hypothesized connection and expressly preserves every right. Writing only to one of the possible liable parties does not necessarily protect you against the others. One must not assume that negotiations with the manufacturer will also interrupt the time limit against the facility or the healthcare professional.
For disputes relating to compensation for healthcare liability, Article 8 of Law No. 24 of 2017 provides for preliminary technical consultation for conciliation purposes or, alternatively, mediation before going to court. Actions directed solely against the manufacturer instead follow the procedural path proper to product liability. The correct classification of the claim therefore also affects the preliminary step.
Before deciding, it is useful to gather medical records, informed consent, the device card, reports, images, recall communications and incurred expenses into a single file. These documents do not replace technical assessment, but they make it easier to understand whether the problem concerns the product, the treatment or both, and help prevent the loss of evidence.
Frequently asked questions
Does a simple malfunction entitle me to compensation?
No, the malfunction alone is not enough. You must prove that the device did not offer the legitimately expected safety, that you suffered damage and that the defect caused it. A failure without consequences or caused by improper use, normal wear or omitted maintenance requires a different evaluation.
Can I take action against both the manufacturer and the healthcare facility?
Yes, when distinct or concurrent liabilities emerge. The manufacturer may be liable for the original defect; the facility may be liable for inadequate choice, installation, use, maintenance or monitoring. However, contested facts, evidence, time limits and preliminary steps must be considered separately for each party.
What can I do if the device is removed?
It is important to document its identity and conditions. When the clinical situation allows, you can ask for the model, batch, serial number, product appearance and custody methods to be recorded. Health protection comes before evidentiary needs, but timely documentation can prevent the loss of an important technical assessment.
Does a manufacturer recall automatically prove the defect?
No, a recall is a relevant element but not always decisive. It must be verified whether it covers the exact model or batch used, what risk it signals and whether that same risk produced the damage. For certain life-saving implantable devices, belonging to the series may nevertheless carry particular weight.
How much time do I have to claim compensation?
The deadline depends on the party and the action. Against the manufacturer, the three-year limitation period runs from knowledge of the damage, defect and responsible party, alongside the ten-year limit from the date of placing on the market. For the facility, the term is normally ten years; for the healthcare professional who is liable under tort law, it is generally five years.
How to navigate without confusing liabilities
Original defect, improper use and insufficient maintenance lead to different claims. Identification of the device, medical records, safety notices and product preservation help reconstruct the cause of the damage. If you want to clarify which liabilities, time limits and steps apply to your situation, you can contact me.