The newly published extension of the Medical Device Regulation (MDR) transitional provisions (Regulation (EU) 2023/607 of 15 March 2023) has released some tension in reaching MDR certification. The extension is primarily aimed at freeing up more capacity of notified bodies to perform conformity assessments and essentially avoiding shortage of medical devices on the European market. It also gives manufacturers more time to gather the relevant data, update the Technical Documentation and obtain the CE mark.
The extension however is dependent on several factors and industry needs to observe aspects of the MDR compliance that are irrelevant to the extended transitional period for ‘legacy devices’. Certain areas of UDI obligations fall into that bucket.
MDR introduced the requirement for Unique Device Identification (UDI) system to aid in device identification and traceability. UDI implementation spans across multiple areas of manufacturers activities – UDI assignment, placement of UDI carrier on device labelling, registration of UDI and device attributes and procedural setup – each with their own deadlines and dependencies.
How does the MDR amendment affect the implementation of UDI system? Let’s take a look if and how the MDR extension influences the different elements of UDI.
UDI Labelling – extension aligned for ‘legacy devices’
The deadlines for application of UDI carrier as required per Article 27(4) are laid out in Article 123: 26 May 2021 for class III and implantable devices, 26 May 2023 for class IIa and class IIb devices and 26 May 2025 for class I devices. Reusable and reprocessable devices requiring UDI carrier on the product itself get additional two years.
The extended transition period applies only to ‘legacy devices’, i.e. devices covered by MDD certificate valid as of 26 May 2021 and not withdrawn since. While the Regulation itself lacks any specific reference to the application of UDI carrier for legacy devices, MDCG guidance 2021-25 on application of MDR requirements to ‘legacy devices’ qualifies Article 27 as not applicable. Hence the staggered deadlines of the MDR amendment can be applied when it comes to UDI placement on labelling of a ‘legacy device’:
- ─31 December 2027 for class III and class IIb implantable devices (except certain devices for which the MDR provides exemptions);
- ─31 December 2028 for other class IIb devices and class IIa, class Im and class Is devices.
UDI Registration – no impact, driven by EUDAMED functionality
Here the situation is quite different. There is no mention in the MDR amendment to change the mandatory UDI and device registration timelines. MDR Article 120 (section 3 of the original text and section 3d of the amending Regulation) states that the obligation to register devices, among other requirements such as those relating to PMS, market surveillance, vigilance and registration of Economic Operators, is unaffected by the additional transition period. MDCG 2019-5 provided further clarification highlighting that ‘legacy devices’ need to be registered in line with MDR provisions (more specifically those regarding EUDAMED availability) and it was reiterated in the more recent MDCG publication 2021-25.
With the MDR extended transitional provisions being irrelevant to the UDI and device registration requirements, the due dates are dictated by the functionality of EUDAMED. The European Database on Medical Devices had several delays in the course of its implementation and some of the modules are still to be rolled out. The modules on Actor, UDI & Device and Notified Bodies & Certificates (except for the mechanism for scrutiny and CECP functionalities) are already available and can be used on voluntary basis. The remaining modules – Vigilance, Clinical Investigation & Performance Studies and Market Surveillance – are still under development.
The obligatory use of EUDAMED will start when all of its modules are in place and the system is declared fully functional, following an independent audit and a notice publication in the OJEU. Taking into consideration the MDR provisions relating to the delays of EUDAMED release, the mandatory UDI & Device registration period is currently expected to be:
- ─Q4 2024 (6 months after the OJEU publication) – the use of Actor, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance modules becomes mandatory. It is important to note that in cases of vigilance reporting, UDI and device data needs to be registered at the same time to allow for proper linking of information across the modules;
- ─Q2 2026 (24 months after the OJEU publication) – the use of EUDAMED becomes mandatory in terms of requirements related to the UDI & Device and NB & Certificates modules.
These timelines as based on the currently available EUDAMED plan, which assumes that the development of all six modules will be completed by the end of this year. Publications in the EUDAMED space need to be observed for any potential impact on readiness and due dates.
UDI in QMS – caution and efforts needed
Significant part of UDI implementation is ensuring that the UDI is adequately captured in company’s Quality Management System. The UDI requirements are brand new under the European legislation and manufacturers should develop an internal implementation program considering the requirements, roles and responsibilities, scope and training. A UDI issuing agency needs be selected, their standards adopted and means of data submission to EUDAMED should be determined, including any impact on existing software or systems, where data automation comes into play. UDI carrier implementation strategy, including assignment, placement and barcode verification, needs to consider adequate checks and equipment validation. Last but not least, UDI requirements need to be integrated within the affected areas of QMS.
Manufacturers who place their devices on the US market are familiar with the UDI system and some aspects of UDI data submission, at least those that are common with the EU system, and can leverage the processes towards MDR compliance. For many others however the topic is new, and the implementation starts from a blank sheet. Affected processes include design & development, labelling and packaging, change control, production & process, reporting, devices registration & submissions and records & documentation. Significant QMS updates will be necessary and new procedures may need to be generated to cover all requirements.
One of the conditions of applying the extended MDR transitional provisions is QMS readiness. By the time manufacturers are submitting their application for conformity assessment to the notified body, and no later than 26 May 2024, the Quality Management System must be in compliance with the MDR. This includes UDI related aspects – processes for UDI assignment, applying UDI carrier to device labelling as well as data registration, verification and maintenance.
Key takeaway
The extension of the MDR transition period was necessary to secure the healthcare supply chain and ensure availability of medical devices on the EU market. It is essential not only to use the additional time wisely and to continue pushing towards achieving MDR compliance, but especially in relation to the UDI requirements brought up above, to pay attention and address the obligations that come in sooner than the new compliance dates for ‘legacy devices’.
More information?
Qserve can support activities of UDI assignment and labelling utilizing issuing agency standards, UDI & Device registration in EUDAMED and integrating UDI requirements within QMS. If you need any assistance, please feel free to contact us