In this post of our “Getting ready for the MDR” series, we analyse the most important requirements for device identification and traceability that will be imposed on manufacturers and other economic operators placing medical devices on the EU market.
MedTech Europe, the association representing the European medical technology industry, estimates that approximately 500,000 different medical devices are currently available in the EU. However, no precise data exist on the number, the types and the approval status of medical devices on the EU market, let alone the evidence supporting their use and the conformity assessment they underwent. This lack of transparency is particularly troubling for implantable and high risk devices. In addition, the current Directives remain silent on traceability of medical devices, so that sporadic national or regional requirements, particularly for implantable devices, are often incompatible and place a considerable administrative burden on device manufacturers marketing products in different Member States.
The EU Medical Devices Regulation (MDR) seeks to introduce several measures to ensure the transparency and traceability of EU devices in the interest of patient safety, while at the same time facilitating free movement of goods and controlling the industry’s costs. As a general requirement, already provided by the European Commission’s Blue Guide, the MDR requires the identification of economic operators up and down the supply chain. In particular, economic operators must be able to identify to the competent authority any economic operator as well as any health care institution or professional to whom they have directly supplied a device. Additionally, economic operators must be able to identify any economic operator who has directly supplied them with a device.
Enhanced transparency through reinforced Eudamed
The scope of the existing European databank on medical devices (Eudamed) is currently limited to administrative information about class I devices and most in vitro diagnostics (IVDs), their manufacturers and authorised representatives, vigilance data (such as information on CE certificates and vigilance reports) and clinical information (for example, notification of early termination of a clinical investigation, authority interventions, etc.). The database only allows information exchange between national competent authorities and the Commission, and is not accessible to the public (patients, health care professionals, etc.). Manufacturers of class I medical devices and most IVDs or their authorised representatives submit details of devices to national regulators, who then populate Eudamed. For devices in class IIA and above, the manufacturer need not register the device on Eudamed, but it must include the relevant notified body number on the product’s packaging, although some member states (e.g. France) operate their own national databases of other classes of device. For all but the lowest risk class I devices and most IVDs, it is therefore impossible to tell which medical devices are presently on the EU market (let alone access more detailed clinical and safety information) without consulting 27 different member states.
In order to address this issue, Eudamed will be significantly reinforced in order to ensure identification and traceability of medical devices and economic operators. Eudamed will be accessible not only to member states, the European Commission, Notified Bodies and economic operators but also to the public. As regards traceability of economic operators, importers must now also register to Eudamed before placing a device on the EU market, as manufactures and authorised representatives are currently doing under the MDD and AIMDD system. The MDR provides that manufacturers, authorised representatives and importers must obtain a Single Registration Number in order to register to the electronic system on registration of economic operators of Eudamed. Additionally, the Single Registration Number is necessary for manufacturers when applying to a Notified Body for a conformity assessment.
While the MDR does not mention any registration requirement for distributors, it leaves to the discretion of member states whether to introduce national registration requirements for distributors.
The MDR provides that Eudamed must contain personal data only when necessary to comply with the MDR. Personal data must be kept in a form that permits identification of data subjects only for ten years or 15 years for implantable devices.
Unique Device Identification (UDI) system
The PIP breast implant and the metal-on-metal hip implant scandals highlighted the absence of a system enabling the identification of patients carrying defective implants. Some member states are currently applying national device registration requirements, thereby increasing manufacturers’ administrative burden when required to separately register in each member state.
Following international guidance and in particular the US experience, the MDR has incorporated rules establishing a system of UDI and obligations that apply to manufacturers and other economic operators. The UDI will apply to all devices placed on the EU market (except custom-made devices) and will consist of a series of numeric or alphanumeric characters allowing identification of a specific device. Manufacturers must assign to their devices (or packaging) the UDI and submit all the relevant information to the UDI database, which forms part of the electronic systems included in Eudamed.
Timelines for assigning the UDI depend on the class of the device. Manufacturers must place the UDI for class III and implantable devices as of 26 May 2021; for class IIa and class IIb devices as of 26 May 2023; and for class I devices as of 26 May 2025. Authorised representatives, importers and distributors have a legal obligation under the MDR to verify if manufacturers comply with the UDI requirements.
Under the MDR, manufacturers will avoid multiple registrations and ensure better tracking and tracing of their devices e.g. in the event of a recall or other corrective action. It will allow more accurate reporting, reviewing, and analysing of adverse event reports and should reduce medical errors by enabling health care practitioners to more rapidly and precisely identify a device and obtain important device-related information. UDI will also play an important role in identifying counterfeit devices and establishing a secure global supply chain.
Manufactures of implantable devices must provide an implant card accompanied by specific information to all patients with an implanted device. This information must allow the identification of the device, including the device name, model, the UDI, lot number, serial number, and the name, address and website of the manufacturer. Among others, the manufacturer must provide any warning, precautions or measures to be taken by the patient or the healthcare professional and any information about the expected lifetime of the device.
Manufactures are strongly advised to set up or adapt existing internal procedures in order to comply with the new MDR requirements.
This post was co-authored by Eftychia Sideri.