The European Commission (EC), the EU regulating authority in the sphere of medical devices, has published a document describing the regulatory requirements under the MDR EUDAMED framework.
The new guidance published by the European Commission describes the way in which Legacy Devices should be identified in the EUDAMED system, as well as the approach to be applied for Unique Device Identifiers assigned to such devices.
According to the definition provided in the present EC guidance, Legacy Devices are defined as Medical Devices, Active Implantable Medical Devices, and In Vitro Diagnostic Medical Devices that are covered by a valid certificate issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC, or Directive 98/79/EC, and that continues to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR). The document also refers to the regulatory requirements for the registration of legacy devices outlined in the appropriate guidance document MDCG 2019-5 Registration of legacy devices in EUDAMED April 2019.
The European Commission states that medical device manufacturers would be allowed to register the legacy devices they produce and place them on the market in EUDAMED. In particular, such registration should be mandatory in case of serious incidents taking place, or if the medical device manufacturer announces the filed safety corrective actions to be taken with regard to the medical device already placed on the market. In the aforementioned cases, the appropriate registration should be carried out without undue delay. The EC additionally emphasizes that the registration should take place prior to submission of a final vigilance report.
Moreover, according to the applicable regulatory requirements, any medical device placed on the EU market should be either aligned with the requirements set forth by the new regulations and registered accordingly, or registered in EUDAMED within 18 months from that date the new regulations become applicable. At the same time, a longer period should be applied in case if EUDAMED would not be fully operating till that time.
It is also important to mention that Class I non-sterile legacy devices without measuring function, that are currently placed on the market under the Directives, are not subject to regulatory requirements for legacy devices addressed herein since such devices are actually falling outside the scope of the mandatory assessment to be carried out by a Notified Body. Such devices should be registered as Regulation Devices. The timeline remains the same – 18 months from the date the Regulations become applicable.
Identification Details for Legacy Devices
The present EC guidance also highlights the most important aspects related to the identification of legacy devices, including the regulatory requirements related to identification elements to be applied. The EC mentions that in the case of legacy devices, some exemptions from the general rule should be applied, especially in terms of a Basic UDI-DI and a UDI-DI.
First of all, it is important to mention that under the general rule, in the case of legacy devices, the assignment of a Basic UDI-DI and UDI-DI is not required. However, according to the guidance, in order to keep the same standard structure and identification elements for all devices registered in EUDAMED, an identification element EUDAMED DI (the equivalent of the Basic UDI-DI) will be required, and a EUDAMED ID (in case no UDI-DI has been assigned) will be generated from the EUDAMED DI.
Thus, a Basic UDI-DI should not be applied with regard to the legacy devices, while EUDAMED DI should be used instead. Nonetheless, a UDI-DI could still be applied in the context of legacy devices. The EC additionally emphasizes that each medical device covered by the scope of the present guidance should be assigned with only one device identifier: it should be either a UDI-DI or a EUDAMED DI.
In order to assist the medical device manufacturers in achieving and sustaining compliance with the applicable regulatory requirements described herein, the EC also provides a flow chart describing the approach to be applied with regard to the management of unique device identification elements for legacy devices.
For the same purpose, the EC guidance on legacy devices also provides some sample cases explaining the way the applicable regulatory requirements should be applied. The examples provided by the EC include, inter alia, the following ones:
- If the legacy device in question already has a UDI-DI assigned thereto, its manufacturer is allowed to use it as an identifier, while the UDI-DI value would be used to generate the EUDAMED DI. Consequently, the medical device could be identified by the virtue of both a EUDAMED DI and a UDI-DI initially assigned by the medical device manufacturer. Actually, a EUDAMED DI comprises a UDI-DI plus the character “B-” is placed in front of it.
- If the legacy device in question does not have a UDI-DI assigned by its manufacturer, the additional identifiers should be assigned, including a EUDAMED DI and EUDAMED ID. The latter has the same format, as a EUDAMED DI, but the character to be used is “D-” instead of “B-”.
Thus, the new EUDAMED identifiers are based on the existing UDI-DI of a medical device, plus a special character to be added in front of it.
Correspondence Between Regulation Devices and Legacy Devices
The present EC guidance also describes the way the regulation devices correspond to the legacy devices. According to the document, a regulation device stands for the medical device fully compliant with the regulatory requirements set forth by the new Regulations. Hence, a regulation device is subject to mandatory registration in EUDAMED as per the regulatory requirements prescribed by the MDR and IVDR.
The EC additionally mentions that the new European medical devices database allows linking of the regulation device with the legacy device based on the same UDI-DI used for both products. In such a case, the UDI-DI assigned to medical devices would be used to build connections between the appropriate entries. In case if a regulation device is the same as the legacy device, the UDI-DI used could be the same as well. Hence, these two products would be linked automatically. However, the medical device manufacturer may also create such a link manually by the virtue of the legacy device identifier.
EUDAMED DI Identification Number Format
The document described herein additionally provides detailed information about the format of the EUDAMED DI identification number to be applied in case if it is not being generated from an existing UDI-DI. The EC emphasizes the importance of consistency in the formatting structure. Actually, the structure used in EUDAMED is similar to the Global Model Number (GMN) and has the following features:
- The length of the identifier should not exceed 25 characters together with the prefix and check digits),
- The subsets of characters used could be the same as used in other structures,
- The identifier contains a two key check-digit,
- The prefix “B-” has been introduced as a core element of a new EUDAMED format.
Summarizing the information provided here above, the present EC guidance describes the approach to be applied for legacy devices, especially in terms of identifiers to be used. The document highlights the most important regulatory requirements and provides additional clarifications associated thereto.
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