The need to replace an implant is not, by itself, proof of malpractice or of a nonconforming product. The product's expected conditions of use, the patient's condition, the placement technique, follow-up and the course of events are examined together. On the other hand, a CE mark or a market authorization does not provide immunity from liability for all harm that occurs. The duty of care in health services and liability for product safety answer different questions.
How is a medical device defect distinguished from a medical application error?
Problems arising from the product itself
Problems of design, manufacture, material, sterility, labeling or the information on safe use may be examined as matters of the product's conformity. The existence of similar incidents involving the same model or batch may support the technical assessment; however, it must still be shown separately that the product used on the patient actually falls within that scope and is connected to the harm.
The conformity of a device with the legislation cannot be resolved by looking at the label alone. Conformity documents, intended purpose, the technical file, production and batch information, safety notices and, where necessary, laboratory examination are assessed together. Law No. 7223 regulates product safety and compensation liability for harm caused by products; the special rules on medical devices are also important within this framework. 1–2
A refund or replacement of the product is not the same claim as compensation for bodily harm. The consumer's optional rights in respect of defective goods should not be confused with the right of the injured person to be compensated for the loss of health suffered because of the product. Reimbursement of the implant price alone does not mean that all treatment and work losses are also compensated. 1, 3
Errors of selection, placement, use and maintenance
A technically suitable device may have been selected inappropriately for the patient, used in the wrong size or placed incorrectly. Failing to maintain, calibrate or carry out the necessary checks on the device is also a separate area of liability. Which check is necessary must be determined by the nature of the device, the manufacturer's instructions, the conditions of use and the applicable regulations.
As regards the physician's liability, the indication, the alternatives, the choice of product, the application technique, the information given to the patient and the follow-up plan are examined. As regards the hospital, procurement and traceability, storage, sterilization, maintenance organization and the proper use by staff are assessed. The fact that a device was obtained through a service contract does not automatically remove all of the hospital's obligations; the allocation of duties and the actual supervision are investigated. 2, 4
Ordinary risk, wear and the patient's conduct
It cannot be assumed that every implant offers an unlimited lifespan and an unconditional guarantee of success. Known risks, the patient's accompanying illnesses, trauma or the conditions of use may ultimately have an effect. However, a general defense such as "an implant can break anyway" does not amount to an adequate examination if it does not explain the cause of an early fracture.
Suppose, hypothetically, that two implants of the same model caused problems in different patients: the same legal result cannot be reached merely because the model is shared. In one case a material problem may be at work, in another incorrect placement of the product or a later trauma. The examination should compare the alternative causes; a statement of normal risk should not replace technical investigation.
Liability of the manufacturer, importer, seller and health institution
The manufacturer and importer under Law No. 7223
Article 6 of Law No. 7223 regulates the liability of the manufacturer or importer for harm that a product causes to a person or property. The injured person must prove the harm suffered and the causal link between the nonconformity and the harm. For this reason, it is not sufficient merely to point to the product brand or to submit a recall from another country. The specific product, the nonconformity and the specific harm must be connected. 1
It is not laid down as a mandatory condition that the patient purchased the product directly from the manufacturer. For an implant used during surgery as well, identifying the chain of production and import is important. Where more than one manufacturer or importer is liable for the same product-related harm, the statutory provision on joint and several liability comes into play. Contract terms that remove or reduce liability are not accepted as valid under Article 6.
This regime is not the same examination as proving the physician's professional fault. In the doctrine, the nature of product liability, the concept of "nonconformity" and the difficulty of proof are also discussed separately. The statutory conditions of proof should be distinguished from the interpretations proposed in the doctrine, and it should not be assumed that the patient can access all technical data on their own. Having technical documents produced through the court may therefore become important. 1, 5
Is a distributor or seller automatically treated as the manufacturer?
No. Article 11 of the Law separately regulates when an importer or distributor is treated as a manufacturer. Placing a product on the market under one's own name or brand, or making a modification that affects the product's conformity, are among such cases. There is also a special condition regarding failure to disclose the supply chain for purposes of compensation. 1
Where the manufacturer, authorized representative or importer cannot be identified, the claim directed by the injured person matters. A distributor that does not provide the details of the relevant operators, or, if it does not know them, those of the previous supplier, within ten business days of the notification of the request, may be held liable as a manufacturer under Article 11/3. This period is not the period for the patient to bring a compensation action; it is a separate condition relating to the request for information addressed to the distributor.
The seller's contractual obligations arising from defective goods, or its own faulty conduct, may also be assessed on different grounds. Both generalizations, "the seller is never liable" and "everyone who sells the product is liable for all harm like a manufacturer", are therefore wrong.
Where a product nonconformity and a doctor's error exist together
Where a third party's act contributes to the harm together with a product nonconformity, this does not, for that reason alone, reduce the manufacturer's or importer's product compensation liability under Article 21/3 of Law No. 7223; the right of recourse against the third party is reserved. On the other hand, proof that the nonconformity arose entirely from a third party's intervention is assessed separately under the same article's provisions on release from liability. 1
The contribution of the injured person's fault is regulated differently: depending on the circumstances, liability may be reduced or removed. It must be investigated which instruction the patient received, whether the instruction was understandable and what real effect the patient's conduct had on the harm. Merely saying "did not come to the check-up", without having given the necessary explanation, may not be enough to shift all liability onto the patient.
What do the CE mark, a recall and the implant card show?
The limits of the CE mark and of a recall decision
The CE mark is one element of the applicable conformity assessment system; it is not a guarantee that no device will ever malfunction or that it will suit every patient. Conversely, a recall or safety notice does not show that harm has occurred in every user. The model, batch, problem and recommended action covered by the notice must be matched with the specific file. 1–2
The exception to administrative sanctions relating to a voluntary recall of a product must be distinguished from the patient's right to compensation. That no administrative sanction is applied under the conditions in Article 21/1 of Law No. 7223 does not mean that bodily harm that has already occurred will automatically go uncompensated. The grounds for release from compensation and their proof are separately regulated. 1
On the basis of news of a recall, a decision that the implant must be removed should not be taken personally. The need for follow-up, checks or revision is assessed by the competent health team. The legal review should record the date of the notice, whether the patient was reached and whether the recommended measures were applied, without delaying the necessary health care.
The implant card and UDI information
Article 18 of the Medical Device Regulation regulates, for implantable devices within its scope, the information identifying the device and the information the patient will need. The model, serial or lot number, the unique device identifier known as UDI, and the manufacturer's details make the product easier to trace. The implant card linked to the patient's identity by the hospital, and the explanations given, are important in investigating a problem that arises later. 2
However, Article 18/4 contains exceptions for certain devices. For dental fillings, braces, dental crowns, screws, plates and the other products listed in the provision, the scope must be checked separately. For this reason, the absence of an implant card in every patient is not automatically a violation or a ground for compensation. The exception for dental crowns should also not be stretched to mean that all dental implants fall within the same scope.
A UDI or Product Tracking System record supports the identity and traceability of the product; on its own, it does not prove the cause of the harm. If there is no card, identification of the product may be sought through the surgical file, the product label, the invoice, and the hospital's stock and usage records. A general brand notice should not be accepted without a link being established to show on which patient the product was used.
How is evidence protected in device and implant harm?
Combining the medical file with the technical file
Within the framework of the relevant legislation, the patient may examine their medical file and request copies. Besides the operative note and the discharge summary (epikriz), the product label, implant details, imaging, follow-up records and the reason for revision are important. Direct access to every technical document held by the manufacturer or hospital may not be possible; having the document produced through an appropriate judicial route and an expert examination are considered. 6–7
| Subject of examination | Priority evidence | What does it help to distinguish? |
|---|---|---|
| Identity of the product | Implant card, label, serial/lot, UDI, usage record | Is the product used on the patient the same as the product covered by the notice? |
| Application | Operative note, imaging, product selection and size information | Is it a product problem, or an error of selection or placement? |
| Maintenance and use | Maintenance, calibration, malfunction, sterilization and training records | Did later conditions of use have an effect on the product? |
| Safety notice | Text of the recall, batch scope, notification and communication with the patient | What was done after the risk became known? |
| Harm | Revision file, loss of function, expense and income documents | Which loss did the alleged error cause? |
Preserving the removed implant
An implant removed in a revision operation may be important for technical examination. Before the procedure, where possible, the hospital should be notified in writing so that the fate of the product is recorded and appropriate preservation is considered. With regard for health, infection safety and institutional procedures, the person who receives it, the date, the packaging and the product identity should be recorded.
It cannot be recommended that the patient or a relative transport, clean, take apart or test a device contaminated with biological material in an improper way. These acts may create a safety risk and may also change the nature of the evidence. If the product has to be sent to the manufacturer, it is important that the identity, photographs, handover and examination conditions are traceable before it is sent.
If there is a danger that the product will be lost or altered, preservation of evidence (delil tespiti) may come into question within the conditions of legal interest. Whether the examination requires destructive testing and the protection of the remaining sample should be assessed with the experts. A request to preserve evidence does not mean delaying a necessary operation or that the patient makes the medical decision alone. 7
The expertise of the expert panel
A clinical assessment alone may not be enough to resolve an allegation of a material or electronic fault. Besides the relevant medical branch, engineering, materials, biomedical or other technical expertise appropriate to the nature of the device may be needed. The expertise of the panel should be determined according to the subject of the dispute.
The report should compare production problems, application technique, maintenance, ordinary wear and causes attributable to the patient. The finding that "the product broke" is not the same as the cause of the fracture. A finding that the medical application was faultless should also not prevent examination of a nonconformity in the product. If the technical reports conflict, it should be explained which assumptions and data led to different conclusions.
Court route, limitation periods and options for applying
Which respondent is pursued through which judicial route?
For harm arising from a public hospital's service fault, an application to the relevant administration and a full remedy action (tam yargı davası) are, as a rule, considered. For a private hospital's service that has the nature of a consumer transaction, consumer law comes into play. For a claim against the manufacturer, importer or seller, the parties' capacity, the nature of the relationship and the basis of the claim are examined separately. The fact that the defendant is a company does not on its own make the case a commercial case. 1, 3, 8
In disputes to be heard before a consumer court, mediation as a condition for bringing the action, the jurisdiction of the consumer arbitration committee and the statutory exceptions must be checked. The consumer's place-of-residence jurisdiction is also assessed. That product and public-service allegations arise from the same incident does not mean that all claims will be heard in the same branch of the judiciary by a single petition. The time-limit consequences of choosing the wrong respondent or forum should be examined in advance.
For a product made by a foreign manufacturer, identifying the importer in Türkiye and the supply chain is of practical importance. A decision or class settlement in a foreign country does not of its own accord create the same right to payment for a patient in Türkiye. The identity of the product, the applicable law, jurisdiction, service of process and the effect of the decision are assessed separately.
The three-year and ten-year periods in product compensation
Under Article 6/6 of Law No. 7223, the period for a product compensation claim is three years from the date the injured person learns of the harm and of the party liable for compensation, and in any case ten years from the date the harm occurred. The ten-year start under the Law cannot be automatically replaced with the date the product was placed on the market or the date of the surgery. When the harm occurred may require a specific medical and legal examination. 1
The Law entered into force on March 12, 2021. For events from an earlier period, it cannot be assumed that all provisions will apply retroactively merely because the action is filed today. The dates of placing the product on the market, use, harm and learning should be recorded, and the law applicable in terms of time should be determined. 1
| Legal basis | Basic time-limit framework | Point to note regarding the start |
|---|---|---|
| Art. 6 of Law No. 7223, product compensation | 3 years from learning, 10 years from the occurrence of the harm | Not automatically equated with the date of placing on the market. |
| Art. 72 TBK, tort | 2 years from learning, as a rule 10 years from the act | Conditions for the longer criminal limitation period are reserved. |
| Mandate claim | 5 years under Art. 147/5 TBK | Does not automatically apply to all hospital and product contracts. |
| General contractual claim | 10 years under Art. 146 TBK unless there is a special period | Maturity and special provisions are checked. |
| Harm from an administrative act | Application to the administration within 1 year from learning, and in any case within 5 years from the act | In late-emerging harm, learning and the link to the act are assessed. |
| Action after the administrative application | Generally 60 days after notification of the rejection or the 30-day silence | Calculated from the application and notification documents. |
Consumer claims such as replacement of defective goods should be distinguished from the periods that apply to compensation for bodily harm caused by the product. A notification to the TİTCK (Turkish Medicines and Medical Devices Agency), a complaint to the hospital or talks with the manufacturer do not of their own accord stop all periods. A lengthy product examination also does not remove the need to monitor the litigation calendar. 1, 3–4, 8
Recoverable damages and the financial side of the file
A revision operation, additional treatment, rehabilitation, care needs, loss of earnings and reduced working capacity may be examined as pecuniary damage once their conditions are met. Claiming the necessary check-up and monitoring expenses requires showing their medical necessity and their connection to the incident. It is not possible to treat all future expenses as damage that has already arisen merely because a safety notice has been published. 1, 4
Non-pecuniary damages for bodily harm, the claims of relatives in cases of serious bodily harm or death, and the loss of support in the event of death are assessed separately. Mere anxiety does not, in every incident, produce the consequences provided for bodily harm. The legal basis of the claim and the effect actually experienced by the person must be shown.
A manufacturer's offer of a free replacement or a hospital's offer of a free revision may not mean that all of the harm has been covered. Release and waiver clauses in a payment or replacement document should be examined for scope and validity. The same harm cannot be collected twice; the product price, the revision expense and the other items must be calculated separately.
Technical examination, expert and, where necessary, translation costs should be taken into account in the litigation plan. The consumer court-fee exemption does not remove all costs; if the conditions are met, legal aid may be considered. Appeal routes after judgment, enforcement and insurance coverage are separate subjects. No guarantee of collection can be given without examining the payment obligations of the manufacturer, importer, hospital and insurer. 3, 7
Conclusion
In harm caused by medical devices and implants, the right legal approach is to examine, together but through separate questions, the conformity of the product, the care of the health service and the patient's specific harm. The CE mark does not provide general immunity from liability; a recall or a fractured implant does not, on its own, create automatic compensation. A claim aimed only at the brand, without protecting the product identity and the evidence, may remain incomplete.
The implant card, the serial or lot information, the surgical and maintenance records and, if applicable, the safe preservation of the removed device form the basis of the examination. The correct judicial route and time limit must be determined for each respondent; in particular, the ten-year period tied to the occurrence of the harm under Law No. 7223 should not be confused with the starting points of other regimes.
Frequently Asked Questions
If the implant broke, is the doctor necessarily at fault?
No. A manufacturing or material problem, selection and placement technique, maintenance, trauma and other causes must be investigated. The fracture itself and the cause of the fracture are not the same evidence.
Can compensation be claimed from the manufacturer for a CE-marked device?
If the conditions are met, yes. The CE mark does not remove the examination of any nonconformity in the specific product and of the harm. The causal link between the harm and the nonconformity must be shown.
If a product is recalled, should I have the implant removed right away?
This decision should not be made on personal guesswork. The scope of the notice and the follow-up or intervention suitable for the patient are assessed by the health team. Collecting legal records should not delay necessary health care.
If I do not have an implant card, can I not assert any rights?
No. There are exceptions to the card provisions for some devices. In addition, the product's identity can be investigated from the surgical file, the label, the invoice and the hospital's usage records.
Does the ten-year product compensation period start on the date of surgery?
The wording in Article 6/6 of Law No. 7223 is the date the harm occurred. It may be the same as the date of surgery, but it cannot be assumed to be so automatically in every case. The applicable law and the other periods must be assessed separately.
If the manufacturer is abroad, can I apply only to the doctor?
No. The importer in Türkiye, the supply chain and other responsible parties can be investigated. Questions of jurisdiction and service of process concerning a foreign manufacturer are examined separately; the doctor's liability is likewise determined on the basis of the doctor's own conduct.
Sources
1. Law No. 7223 on Product Safety and Technical Regulations, Official Gazette of March 12, 2020, No. 31066; in particular Arts. 6–12, 21, 26. Publication of the Ministry of Trade. The Ministry's statement on entry into force.
2. Turkish Medicines and Medical Devices Agency. Medical Device Regulation, Official Gazette of June 2, 2021, No. 31499 (bis); in particular Arts. 18, 20, 25–27, 34 and safety notices. Official sectoral legislation index. LEXPERA publication of the consolidated text.
3. Law No. 6502 on Consumer Protection, in particular Arts. 8–16, 68, 73, 73/A. Publication of the Ministry of Trade.
4. Law No. 6098 Turkish Code of Obligations, in particular Arts. 49–56, 61, 72, 112, 115–116, 146–149, 502, 506. Ministry publication.
5. Özden Çelt, Damla. “Ürün Sorumluluğunda Yaşanan Güncel Gelişme: 7223 Sayılı Ürün Güvenliği ve Teknik Düzenlemeler Kanunu” (A Current Development in Product Liability: Law No. 7223 on Product Safety and Technical Regulations), Anadolu Üniversitesi Hukuk Fakültesi Dergisi, 7(1), 2021, pp. 73–114. Full text.
6. Ministry of Health. Patient Rights Regulation (Hasta Hakları Yönetmeliği), in particular Arts. 15–18. Official institutional publication.
7. Law No. 6100 on Civil Procedure, in particular Arts. 190, 266, 281, 334 et seq., 400 et seq. Ministry of Justice legislation record.
8. Law No. 2577 on Administrative Procedure, in particular Arts. 7, 13, 31. Revenue Administration legislation publication.