With the MDR deadline approaching in May 2021, most medical device companies are well on their way to getting ready. Here at Acolad, we've been busy with over 250 of our medical device clients, providing medical translations in all EU languages for the MDR requirements.
For those companies that haven’t started, time is quickly running out – however, for IVDR compliance, there is still time to get ready before the May 2022 deadline.
In either case, based on the volume of work for MDR we have handled to date, we have identified the five best practices to consider in your MDR/IVDR planning.
Forecasting and scoping the volume of content that needs to be updated can result in great economies of scale, especially around pricing. Any other updates in the queue can – and should – be rolled into the MDR and IVDR update. This is a prime opportunity to make other changes at the same time. At Acolad, we help our clients to plan and scope these tasks and put in place advantageous pricing.
Legacy translations that haven't changed can be captured and reused through translation memory technology and processed first, taking advantage of legacy approved content. Machine translation can then be applied to new terms. Those will be post-edited by qualified IVD and medical device linguists for consistent quality.
Take advantage of translation automation such as workflow automation, translation management systems, and online portals. At Acolad, the automated workflow starts at the customer portal where work is pushed to an automated production system. This has allowed us to deploy our translation memory and machine translation technology in chained and automated workflows. Our linguist pools are integrated, so that prepared and pre-translated content can flow easily through our translation and review steps.
Many of our clients require a third-party validation step, which is typically executed by customer affiliate offices. This can be time consuming and possibly result in inconsistent quality and missed deadlines. Rather than using client reviewers, we have implemented our own validation step at Acolad, using our subject matter experts (SMEs) for this task. This allows us to take advantage of our workflow and review technologies.
Finally, preparing for the MDR/IVDR deadline is not a one-time effort. To maintain compliance and address the need to keep labeling and quality/performance documentation up to date, agility and change management is necessary. The old, document-based approach of creating IFUs, operating manuals, quality reports and technical documentation doesn't easily support control of regulated content, multichannel publishing and efficient and accurate change management. These are crucial requirements of the new paradigm presented by MDR/IVDR.
The solution for long term efficient MDR/IVDR compliance calls for a comprehensive content strategy, supported by structured content authoring, management and delivery. A content management system can also be integrated with automated translation workflow technology. Acolad is already preparing to implement a structured content authoring strategy with our clients.
Following these best practices can lead to efficient and painless labeling compliance for MDR and IVDR. Acolad has ample experience in supporting our medical device clients to meet the challenges.