Commission Issues New Guidance On Registering And Identifying Legacy Devices In Eudamed
The process for registering legacy devices is like that for registering devices in conformity with the MDR. But there are differences and manufacturers also need to understand how deadlines impact them.
The European Commission has published a document explaining how and when legacy devices will be identified in the new Eudamed medical device database.
Legacy devices are products that have been CE marked in the context of the current medical device directives but not under the new Medical Device Regulation, nor the IVD Regulation.
The Management of Legacy Devices is a technical document, the majority of which consists of flowcharts and other tables, which explains how the different Unique Device Identifiers (UDIs) will be generated/assigned for legacy devices as part of registration.
One of the initial sections, on general considerations, provides some useful overarching points, including:
- Manufacturers will be able to register any of their legacy devices in Eudamed; and
- Where a serious incident occurs or there is a field safety corrective action (FSCA), registration will be required as soon as possible and at least before a follow up or final vigilance report is submitted.
Another general consideration that impacts deadlines requires some deeper analysis. The document states, rather confusingly, that: “If 18 months after the date of application of the MDR or IVDR – or 24 months after the commission publishes a notice saying that Eudamed is ready to go live (MDR Article 34(3) if Eudamed is not fully functional before the date of application of the MDR –the equivalent device is not made compliant and registered as a MDR or IVDR device, the legacy device must be registered in Eudamed within this time period.”
Vladimir Murovec, supervising associate (healthcare and life sciences) at law firm Simmons & Simmons, told Medtech Insight he believes this should be interpreted to mean that not only must MDR/IVDR-compliant devices be registered by 26 May 2024, but also legacy devices if no “equivalent” MDR/IVDR device has been placed on the market and registered on Eudamed. This assumes that the Eudamed database will be fully functional by 26 May 2022, the current goal.
Registration of MDR-compliant devices on Eudamed will be voluntary before that date, from the moment the Eudamed module on device registration is available, which is expected in May this year.
Why Registration Of Directive Products Applies Under MDR
After 26 May, the date of application of the MDR, devices compliant with the current Medical Devices Directive and the Active implantable Medical Devices Directive have to follow certain MDR requirements to benefit from the ‘grace period’ until their certificate expires or until 26 May 2024 at the latest, at which point they must be fully compliant with the MDR.
The same is true for IVDs in that after 26 May 2022, the date of application of the IVDR, those IVDs compliant with the current IVD Directive have to follow certain IVDR requirements to benefit from the grace period until their certificate expires or until 26 May 2024 at the latest, at which point they must be fully compliant with the IVDR.
The MDR and IVDR requirements that they need to comply with include registration of devices in Eudamed, and this entails their unique identification too.
Moreover, registration in Eudamed will be mandatory even earlier than this if there is a serious incident that occurs or a field safety corrective action to apply. In such cases, registration must be as soon as possible and at least before a follow up or final vigilance report is submitted. Device identification is a key element of this registration.
Different Deadline For Class I Devices
The Commission also notes in the document that class I legacy devices under the directives that are not sterile, and/or with a measuring function, are not considered legacy devices because they do not require a notified body certificate.
These must be registered only as Regulation Devices (MDR/IVDR) in Eudamed within the same timeframe, ie by 26 May 2024.
How Legacy Devices Will Be Identified In Eudamed – Using ‘B’ and ‘D’ Prefixes
Differently to MDR/IVDR devices, a basic UDI-DI device identifier will not be assignable to legacy devices. The basic UDI-DI is the main access “key” for device-related information in Eudamed and it is referenced in relevant documentation (eg certificates, declaration of conformity, technical documentation and summary of safety and clinical performance). It is intended to identify and connect devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.
Where the manufacturer has already a UDI-DI assigned to a legacy device, it will be able to use this as a device identifier for the legacy device in the context of the new Regulations.
In this case, the Eudamed DI is automatically generated from the UDI-DI value.
The legacy device will therefore have the following identification elements: a Eudamed DI (generated based on the UDI-DI) and a UDI-DI (assigned by the manufacturer).
To generate the Eudamed DI identification element from the UDI-DI provided, Eudamed will use a standard format, placing the letter “B-” in front of the UDI-DI provided.
The Eudamed DI will be assigned to the device by Eudamed instead of the basic UDI-DI. The Eudamed ID will be assigned by Eudamed instead of the UDI-DI. The Eudamed DI will have a strict format, starting with ‘B-‘ as a prefix and continuing with a set of characters. This is defined in Annex 1 to the document.
The Eudamed ID will have the same format and value as Eudamed DI except the first prefix character. It will start with ‘D-‘ instead of ‘B-‘.
Eudamed ID is the equivalent of UDI-DI so the unique identification at each level of packaging, Murovec explained, whereas Eudmaed DI is the equivalent of Basic UDI-DI so the primary identifier of a model which will appear on the declaration of conformity.
The Eudamed actor registration module became available on a voluntary basis on 1 December and is the first of the Eudamed modules. The other modules are:
- UDI/devices registration (due to become active on a voluntary basis when the unique device identification/device registration module is scheduled to go live);
- Notified bodies and certificates;
- Clinical investigations and performance studies;
- Vigilance and post-market surveillance; and
- Market surveillance.
Medtech Insight has listed Eudamed help tools that have been made available by the European Commission (Also see “How To Register In Eudamed By The December Start Date: Commission Explains” – Medtech Insight, 20 Oct, 2020.)
In addition, guidance on registration of legacy devices in Eudamed is provided in the European Commission’s Medical Device Coordination Group April 2019 document, MDCG 2019-5: Registration of legacy devices in Eudamed.