Traceability of medical devices refers to the ability to identify an individual product or a batch across the entire supply chain and to demonstrate the stages of its journey from manufacture to use. Regulation (EU) 2017/745 establishes this capability not only technically, but as an obligation for all economic operators: under Article 25(1), distributors and importers cooperate with manufacturers and authorised representatives to achieve an appropriate level of traceability. The marking used for this purpose—i.e., the unique device identifier and its components—is described in the entry on the UDI system; this entry addresses the retention, disclosure and information obligations that build on that identifier.
Disclosure obligations in the supply chain
Article 25(2) requires economic operators to be able, during the retention period under Article 10(8), to inform the competent authority to which economic operators they have directly supplied a product, from which economic operators they have directly obtained it, and to which health institutions or healthcare professionals they have directly supplied it.
The principle is therefore one step upstream and one step downstream from each operator’s own link in the chain. No single operator has to know the entire chain; however, the authority can reconstruct it step by step, provided each operator keeps its records. Delivery notes, batch or serial numbers, and recipient data must therefore be linked in such a way that queries can be answered promptly.
Storage of the unique device identifier
In addition, Article 27 obliges economic operators, for certain product groups, to record the unique device identifier of products they supply or obtain and to store it preferably in electronic form. A tiered regime applies to health institutions and healthcare professionals: for implantable Class III devices, requirements apply directly, whereas for other products the Member States are to promote storage and may make it mandatory.
This results in differing national practices that must be checked when entering the market; a storage obligation can only be met if the carrier of the identifier can be captured in machine-readable form at the point of use.
Implant card and patient information
For implantable devices, Article 18 requires a dedicated information channel: the manufacturer provides, with the product, information for identification including the product name, serial number, lot number, unique device identifier, product model, and the manufacturer’s name, address and website, as well as warnings and precautions regarding foreseeable external influences, information on the expected lifetime, and necessary follow-up measures. The identification information must also be provided on an implant card supplied with the product.
Member States require health institutions to make this information quickly accessible to patients and to hand them the implant card including information on their identity. Exempt from this obligation are certain implants with low information needs, including suture material, staples, dental fillings, braces, dental crowns, screws, wedges, dental and bone plates, wires, pins, clips and connectors.
Traceability as a prerequisite for field actions
The actual purpose of all records becomes apparent when an incident occurs. A field safety corrective action can only be implemented in a targeted manner if the affected batches or serial numbers can be identified and the supplied recipients can be named. For this purpose, importers and distributors, under Articles 13 and 14, keep a register of complaints, non-conforming products, and recalls and withdrawals, and cooperate in corrective actions. In practice, a lack of traceability means that actions have to be unnecessarily broad because the affected scope cannot be narrowed down.
Distinction from data traceability and from batch traceability in the GxP environment
In the GxP context, traceability usually refers to the traceability of data: an audit trail documents who created or changed which data record and when, thereby protecting the integrity of study and manufacturing records. This data traceability is a requirement for systems and processes, not for physical objects.
Traceability under Article 25, by contrast, concerns the physical path of a product and the identifiability of its recipients. The two concepts interact, but must be documented separately: a complete audit trail does not replace supply-chain records, and complete batch traceability says nothing about the integrity of the associated electronic records. Also to be distinguished is the traceability of measuring equipment, which is traceable back to calibration standards.
Relevance for clinical trials
In clinical investigations of medical devices, traceability is relevant in two ways. First, each investigational device used must be assignable to a study participant, an investigational site, and a batch or serial number so that product-related events can later be evaluated unambiguously and product defects can be correctly delineated. Second, the return, whereabouts and destruction of unused investigational devices must be documented, which requires an inventory at the individual-item level.
For implantable investigational devices, there is also the link to long-term follow-up, because later patient follow-up requires a robust linkage between the implant, the implantation date and the investigational site. Full-service CROs such as Mediconomics support sponsors and manufacturers in setting up these assignments in the study design, site documents and data capture systems in a way that aligns with the Regulation’s supply-chain and labelling obligations.
Frequently Asked Questions (FAQ)
How long must traceability records be retained?
Article 25 refers to the period under Article 10(8), i.e., at least ten years after the last product covered by the declaration of conformity has been placed on the market, and at least fifteen years for implantable devices.
Do hospitals have to store the unique device identifier?
For implantable Class III devices, requirements apply directly. For other products, Member States promote storage and may make it mandatory, which is why national implementation must be checked.
Is an implant card required for all implants?
No. Article 18(3) exempts a conclusively listed group of simple implants, such as suture material, staples, screws, dental crowns and connectors; the Commission may amend this list by delegated act.
Regulatory References
- Regulation (EU) 2017/745, Article 25 — Identification within the supply chain
- Regulation (EU) 2017/745, Article 18 — Implant card and patient information
- Regulation (EU) 2017/745, Article 27 — unique device identifier and storage obligations
- Regulation (EU) 2017/745, Articles 13 and 14 — registers and cooperation obligations of importers and distributors
- Regulation (EU) 2017/745, Article 10(8) — retention periods
