Warren Lesack, Loftware senior account executive, life sciences writes about how manufacturers should maximise on the additional time now afforded them because of delays to the European Union’s Medical Device Regulation (EU MDR) deadline.
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2024842406
EU MDR
Earlier this year, in an overwhelming majority vote of 537-3, the European Parliament granted an extension to the new EU MDR. Given the multiple issues that have put a strain on market readiness, the approval of an extended transitional period was a clear effort to help prevent device shortages and help companies meet the need for innovative, high-performing devices, and new therapies.
A shifting timeline
Entered into force in May 2017, EU MDR was designed to completely overhaul existing legal regulations for medical devices, replacing the previous Medical Device Directive (MDD) which had been introduced in the 1990s. Its intention was to improve patient and user safety whilst also allowing for the effective functioning of an internal market for medical device products. With more than 500,000 types of medical devices on the market, the EU MDR paves the way to supplying a more patient-focused approach to regulations. Under the new regulation all medical devices, from implants and prosthetics to blood glucose meters and catheters, must meet more stringent safety criteria.
The regulation became applicable on May 26, 2021. In a move that allowed authorities and manufacturers to prioritise their response to the COVID-19 pandemic, the EU postponed this date to May 2024. In February of this year, there was another deadline extension and EU MDR is now due to take effect in 2027 or 2028 depending on the device’s risk class. High-risk devices would be subject to a shorter transition period ending in 2027, while low to medium risk devices would have until the end of 2028 to complete a conformity assessment.
A long road to compliance
The road to implementation of the EU MDR has been a long one. Originally, medical device manufacturers were expected to recertify their MDD (Medical Devices Directive) products under the EU MDR regime by May 2024. Alongside this, there have been increasing concerns that many products certified under the previous regime were to be withdrawn from the market, as companies have struggled to justify the costs of recertification and ongoing compliance, which includes more complex labelling protocols. Put simply, this market response could be disastrous for patients in the EU who could find themselves not only missing out on medical device innovations, but also losing access to trusted products that have been saving lives for decades.
Although the additional time provided by the EU MDR’s deadline extension will allow medical device manufacturers who did not have the time or resources to become EU MDR compliant the opportunity to properly and cost-effectively implement labelling solutions that offer a clear corridor to compliance, there are still challenges to achieving compliance and some manufacturers will have to reconsider whether selling in the EU is a viable option.
The impact on labelling
Medical device manufacturers have hundreds, if not thousands, of Stock Keeping Unites (SKUs), each of which require a label. Ensuring that each of these labels is EU MDR-compliant is a mammoth task, particularly if the company is using manual systems to manage its labels. The extended deadline affords companies the opportunity to review their existing labelling solutions, assessing whether they are sufficiently well-equipped to meet all the necessary requirements.
Across different industries, products must adhere to cross-border regulations. The United States, the EU, and a host of other countries have many importation laws in place. As businesses look to scale and expand into new and emerging markets, businesses must navigate these requirements. When it comes to medical devices, there is an additional layer of complexity – as well as addressing regional divergences in regulation, medical device manufacturers must supply additional information on their labels.
The inclusion of Unique Device Identification (UDI) systems is just one of the several mandatory EU MDR labelling criteria. The UDI of each product consists of two parts: the UDI-DI (device identifier) and the UDI-PI (product identifier). The former contains standard information about a device, such as name, version, number of uses, and critical warning. The UDI-PI holds more dynamic information, including the lot/batch number and expiry dates, which means that UDI-PIs change on a regular basis. EU MDR also requires the inclusion of standard iconography and instructions on how to access eIFUs (Electronic Instructions for Use).
Failure to comply with labelling criteria outlined in EUDAMED (European Database on Medical Devices) will not only result in regulatory enforcement, but also costly product recalls. Deloitte estimates that up to 15% of recalls involving medical devices are due to labelling errors. This is bound to increase once the new guidelines take effect. Apart from product recalls, other implications of non-compliance will include additional levies, fines, retention of shipments at border points, and loss of partnerships, among several others. These operational repercussions may seem drastic but there is no option but to comply.
How to stay compliant
When it comes to labelling, to ensure compliance, manufacturers need to know that the correct identifiers are in the correct place, and to do that they must ensure that key data elements and formats are all reliable. With that in mind, manufacturers require an end-to-end validated labelling solution that provides access to centralised data, all while providing audit tracking and security controls combined with workflow management and eSignature capabilities. Ultimately, complex EU MDR requirements call for such validated labelling solutions that enable dynamic data-driven labelling, ensure security and auditability, and integrate with sources of truth to navigate any regulatory barriers.
Labelling is a mission-critical aspect of the supply chain. And yet, too few companies have the labelling solutions in place to guarantee regulatory compliance, efficiency, validation, brand consistency, responsiveness, customer satisfaction, and revenue. Spreadsheets, legacy systems, and even some software packages are not reliable enough to ensure compliance with the evolving demands of global medical device labelling. The recent EU MDR extension is a gift for medical device and patient communities. Companies must seize the opportunity to address labelling concerns - there is no guarantee that even by 2027 or 2028 the shortage of notified bodies will be resolved so medical device manufacturers need to act now.
