We’re all aware of the impact EU Medical Device Regulation (MDR) has on product labeling, as many Medical Device companies have prepared their multilingual product documentation and labeling for compliance.
The current next step, is to prepare for compliance for the new Summary of Safety and Clinical Performance (SSCP) document that is now required for Class IIa, IIb, III, and implantable devices. Early assessments show significant investment in time and, budget is required to achieve this compliance, but there are ways to mitigate or reduce this impact with some planning and best practices.
What is the Summary of Safety and Clinical Performance (SSCP)?
The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device. The SSCP will be an important source of information for intended users – both healthcare professionals and patients. It’s one of several means intended to fulfil the objectives of the MDR to enhance transparency and provide adequate access to information.
The SSCP should contain 2 sections – patient facing and clinician facing. The patient facing section must be written to be understood by a lay person. One of the languages of the EU, will need to be validated by the notified body (typically this is English) along with the rest of the technical documentation. The SSCP is developed for each device/product and is stored in the European database on medical devices (EUDAMED). For Class III and implantable devices, the SSCP must be updated annually, and for Class IIa and IIb, the SSCP must be updated every 2 years.
Impact on Medical Device companies
Many companies planning for the development, localization, and maintenance of the SSCP to meet the new MDR requirements are evaluating the impact on cost and resources. Development of the source (English) document alone will require significant investment, which is then multiplied as you factor in the language requirements.
For example, each SSCP can range at the high end for Class III devices from 7,000 – 11,000 words/20-35 pages. Each then, is translated into all EU languages. Multiply that by the number of products requiring a translated SSCP – for some companies this is hundreds of documents. For one global company, they estimated 284 SSCP documents needing development and translation. At an average of $18K per language, the investment for translation alone was well over $5M.
SSCPs: Best practices to reduce the impact of MDR compliance
There are several best practices a medical device company can do to mitigate the costs associated with MDR compliance for SSCPs, and these should be factored into the planning.
1. Leverage and reuse content from product labeling to the SSCP
Our analysis of one customer’s instructions for use and draft SSCP found significant reuse across these documents. In this case, the customer had already translated the Instructions for Use (IFUs) in the required EU languages. Leveraging content for the initial development and the translation could produce significant savings.
2. Translation technology optimization – that entails use of translation memory (TM) and machine translation (MT)
As stated earlier, many med device manufacturers have already translated their Instructions for Use (IFUs) into the required EU languages. That means that legacy translation assets stored in translation memory (TM) can be used to reuse this translated legacy for the SSCP. If no legacy translation memories exist, then they can be created from the actual IFU using translation memory post alignment.
In addition, smart deployment of MT for the sections of the SSCP that cannot be leveraged from the IFU will significantly reduce the work required to translate those sections. Once machine translated, the SSCP can then go through a post edit of the complete content by a medical device qualified linguist to ensure quality from the machine output.
3. Component content management strategy
A long-term strategy for managing this content across product labeling and the SSCP could translate into streamlined maintenance. As clinical evidence and post-marketing surveillance (PMS) data drive change to the product labeling and SSCP, this content can be captured in a structured way to be used across labeling and quality documents.A component content management system can facilitate this reuse, reduce risk, and improve quality as the critical pieces of information that need to be updated, can easily be captured and reused consistently and easily reproduced through automated publishing. Structured authoring can also facilitate the creation of consistent terminology that will result in increased reuse from translation memory and higher quality overall.
How content best practices can impact your MDR compliance budget
What are the results of these global content strategies? Initial estimates indicate that the use of TM can reduce costs by 30-40%. An additional 10-15% savings can be achieved through use of MT. And finally, the ROI on implementing a long term CCMS strategy can result in around 60-70% savings.
Following these best practices can lead to a significant reduction in efforts to comply with the new MDR - SSCP requirement. Acolad has ample experience supporting our medical device clients to meet the challenges. Contact us for help in your MDR compliance planning and execution.
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