How to make the most of the extended EU MDR deadline

Warren Lessack, Loftware Senior Account Executive, Life Sciences writes about how manufacturers now have extra time due to delays in the EU Medical Device Regulation (EU MDR) deadline.

Earlier this year, by an overwhelming majority of 537-3, the European Parliament gave an extension to the new EU MDR. Given the many issues that have put pressure on market readiness, an extended transitional approval period is expected to help prevent device shortages and help companies meet the need for innovative, high-performing devices and new therapies. There was a clear attempt.

a transfer timeline

Entered into force in May 2017, the EU MDR was designed to completely replace the current legal regulations for medical devices, replacing the previous Medical Device Directive (MDD) introduced in the 1990s. Its intention was to improve patient and user safety, as well as to allow 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 leads the way in providing a more patient-centred approach to MDR regulations. Under the new rule, all medical devices, from implants and prosthetics to blood glucose meters and catheters, will have to meet more stringent safety standards.

The regulation came into force on May 26, 2021. In a move that allows authorities and manufacturers to prioritize their response to the COVID-19 pandemic, the European Union postponed this date to May 2024. In February of this year, there was another deadline extension and the EU MDR is now due to take effect in 2027 or 2028 depending on the risk class of the device. High-risk equipment will be subject to a shorter transition period ending in 2027, while low- to medium-risk equipment will have to complete a conformity assessment by the end of 2028.

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 re-certify their MDD (Medical Devices Directive) products under the EU MDR regime by May 2024. Because companies have struggled to justify the costs of re-certification and ongoing compliance, which involves more complex labeling protocols. Simply put, this market reaction could be devastating for EU patients, who may find themselves missing out on not only medical device innovations, but also access to trusted products that have saved lives for decades. have been

However, the additional time provided by the EU MDR deadline extension will allow medical device manufacturers who did not have the time or resources to comply with the EU MDR to properly and cost-effectively implement labeling solutions. While this provides 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.

effect on labeling

Medical device manufacturers have hundreds if not thousands of stock keeping units (SKUs), each of which requires a label. Ensuring that each of these labels is EU MDR-compliant is a mammoth task, especially if a company is using a manual system to manage its labels. The extended deadline gives companies an opportunity to review their existing labeling solutions, assessing whether they are adequately equipped to meet all required requirements.

In various industries, products must comply with cross-border regulations. There are many import laws in the United States, the European Union, and many other countries. As businesses seek to expand 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 variations in regulation, medical device manufacturers must provide additional information on their labels.

The inclusion of a Unique Device Identification (UDI) system is one of several mandatory EU MDR labeling criteria. Each product’s UDI consists of two parts: UDI-DI (Device Identifier) ​​and UDI-PI (Product Identifier). The former contains standard information about the device, such as name, version, number of uses, and important warnings. UDI-PI carries more dynamic information, including lot/batch numbers and expiration dates, meaning that UDI-PIs change on a regular basis. The EU MDR is also required to include standard iconography and instructions on how to access the EIFU (Electronic Instructions for Use).

Failure to comply with the labeling criteria outlined in EUDAMED (the European Database on Medical Devices) will result not only in regulatory enforcement, but also in costly product recalls. Deloitte estimates that up to 15% of recalls involving medical devices are due to labeling errors. This is set to increase once the new guidelines come into effect. Apart from product recalls, other implications of non-compliance would include additional charges, fines, retention of shipments at border points, and loss of partnership among many others. These operational consequences may sound harsh but there is no option but to comply.

how to be comfortable

When it comes to labeling, to ensure compliance, manufacturers need to know that the right identifiers are in the right places, and to do this they must ensure that the key data elements and formats are all reliable. With this in mind, manufacturers need an end-to-end valid labeling solution that provides access to centralized data while providing audit tracking and security controls, combined with workflow management and e-signature capabilities. Ultimately, the complex EU MDR requirements require validated labeling solutions that enable dynamic data-driven labeling, ensure security and auditability, and integrate with sources of truth to navigate any regulatory hurdles. There are

Labeling is a mission-critical aspect of the supply chain. And yet, very few companies have labeling solutions in place to guarantee regulatory compliance, efficiency, verification, brand consistency, accountability, 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 labeling. The recent EU MDR extension is a gift to the medical device and patient communities. Companies should seize the opportunity to address labeling concerns – there is no guarantee that the shortfall of notified bodies will be addressed until 2027 or even 2028, so medical device manufacturers need to act now.