The delay of the EU MDR deadline to May 2021 provides medical device manufacturers with a window of opportunity to address their compliance challenges. Businesses must plan carefully to understand where they are at in their compliance roadmap and whether they will be able to meet the requirements within the timeframe, and to an adequate level. Strategic regulatory partners can help to make the planning and implementation process more efficient by offering expert support as and when it is needed. Consultancy support is a valuable tool for achieving timely compliance and ensuring medical devices remain on the market following the deadline. However, manufacturers must properly review the experience and abilities of their selected regulatory and quality consultants, and assess the value that these specialist compliance partnerships can offer to their business.
The EU MDR lays out the new requirements for manufacturers, but it is not always clear how these requirements can be met, especially as the regulation introduces extensive changes. The industry does not yet have comprehensive guidance on what a “state-of-the-art” submission looks like under the EU MDR, so businesses may have to use their own rationale. Experienced suppliers can provide greater clarification, as they work with a variety of organizations to help update processes and documentation. As a result, they should have built up a strong understanding of the requirements, providing an effective industry benchmark to measure activities, and also received notified body feedback for submissions to date. Often, employees at respected consultancies and third-party specialist organizations may have previously worked within a notified body or competent authority, and can therefore provide informed advice from “the inside”.
With regards to documentation, many companies are struggling to update their technical files, clinical evaluation plans and reports, and post-market plans and reports. This is because the EU MDR requires more data than under the previous medical device directives, and businesses may simply not have the time or resources to dedicate to bringing this documentation up to standard. Without the right specialist knowledge, it will be difficult to update all documentation at once. To facilitate the process, regulatory consultancies can provide experienced medical writers, and will ideally have access to a multi-disciplinary team including clinical, regulatory and risk management professionals. They will already have procedures in place to analyze gaps, and can liaise with companies’ subject matter experts as needed, to procure all the necessary product information. This ensures a true client-centric approach that is built on partnership.
Technical files do not need to be updated until their current expiry date, even if this is after the EU MDR deadline. However, this means no significant changes can be made to the product in the meantime. For this reason, it is recommended that businesses start working on them as soon as it is feasible to do so; if there are any unexpected changes to a product, they will have to remediate their technical files under tighter time constraints. Bearing in mind the complexity of technical files, and that the data needed may not be immediately available, this may be extremely difficult to achieve internally. In these cases, third-party support can help to alleviate the pressure and speed up remediation.
Understanding and Executing on Complexity
A further challenge for manufacturers is understanding and implementing the new economic operator requirements, especially for larger businesses with a global supply chain. Now that manufacturers, authorized representatives and importers are jointly and severally liable for device compliance, manufacturers must verify that their network of economic operators (including distributors, although they are not liable) is prepared for EU MDR implementation. Contacting each stakeholder and following up is likely to be time-consuming, so deploying additional support may be more cost-effective, allowing company staff to focus on other business activities. However, the chosen partner must be tenacious in their pursuit of results, and continue to follow up until the information needed is made available. They should also have a sound understanding of the specific data that needs to be obtained from the various suppliers. For instance, when assessing the use of materials of concern by suppliers, the entire manufacturing process of these suppliers will need to be verified to ensure compliance.
Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners. Looking for a quick fix is likely to be detrimental in the long-term. Businesses should look out for consultancies that approach projects with a holistic view, to ensure they are getting the most value from the partnership. Rather than simply completing the task at hand, an effective supplier will take time to understand your organization and the pressures you are under, and identify areas of non-compliance, as well as critical information or documentation that needs to be sourced. Without this knowledge, a manufacturer may unknowingly proceed with a submission that is incomplete. Moreover, consultancy providers that have worked with a range of businesses will have encountered numerous unique challenges, and so will already have tried and tested solutions in place to address them.