As the MDR deadline approaches, many Medical Device companies have updated their multilingual product documentation and labeling to be ready. However, compliance isn't done by simply updating product content before the deadline. The new regulation’s focus on post-market surveillance (PMS), product performance and safety will generate more content to be translated, beyond product labeling. Medical device companies should be planning and preparing for these ongoing needs.
The impact of post-market surveillance on translation
The EU Medical Device Regulation 2017/746 (MDR) defines post-market surveillance as:
“All activities carried out by manufacturers in cooperation with other economic operators to institute and maintain a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market, or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventative action."
These activities, as outlined in a post-market surveillance plan, must be maintained as long as a product is on the market. The goal of the PMS plan and system is to ensure patient safety; it must be included for all medical devices, requiring the production of PMS reports (PMSRs) or Periodic Safety Update Reports (PSURs), depending on the device's class.
A PMSR is required for class I devices. Class IIa, IIb and III devices require a PSUR. It must be updated every two years for class IIa devices and annually for classes IIb and III. These reports are dependent on the data collected in the PMS plan.
Part of the PMS plan is Post-Market Clinical Follow-up (PMCF), a continuous process that updates clinical evaluations. PMCF is one of the activities under PMS that tracks real-word clinical experience.
Even though the Medical Device Directive (MDD) had requirements for updating the clinical evaluation with data coming from PMS, the MDR requires a more detailed description of proactive collection and evaluation of clinical data to ensure safety and performance of the device.
Notified bodies check the appropriateness of the PMS plan. Under MDD, it was all about keeping documents up to date; under MDR, it's a continuous collection of clinical data to ensure the product performs and is safe for its stated intended use – throughout its expected lifetime.
The sources of this post-market data can come from user or focus groups, customer surveys, complaints, adverse events, media and literature reviews, and post CE mark trials. The content comes in many languages from all markets, and most of it must be translated to be used in assessment and evaluation of the product, post-market:
1. Focus group and customer survey feedback
To assemble valid data from end users, medical device companies will need to gather focus group or surveys in the languages of the EU end users. This will require translation of questionnaires and surveys, as well as back translation of the responses so that all data will be harmonized and ready for evaluation.
2. Complaints and adverse events
Typically, this content comes in the local language of the patient or the clinician. It will also need to be back translated to a harmonized language (typically English) for evaluation, trending, and further content analysis. A good PMS plan will include vigilance programs to systematically collect the information. A streamlined process for translation, content assessment and further investigation in a timely manner is essential for an effective vigilance program and part of the overall PMS system.
3. Media and literature reviews
Much of this content will be captured in the local language and calls for back translation so that it can be used for evaluation.
4. Post CE Mark trials and Post Market Clinical Follow-up (PMCF)
Depending on the risk category, post-market trials will need to be conducted as part of the PMS plan. This will require translation of typical clinical trial documents, following study processes. In addition, the PMCF plan will outline the studies and data that feed into the PSUR, Summary of Safety and Clinical Performance (SSCP), and eventually labeling and IFUs.
This report, required for class III and implantable devices, provides healthcare workers and patients with current information on the safety and performance of the medical device. The SSCP must be translated into all EU languages and updated annually.
Best practices for post-market surveillance language requirements
While PMS has always generated content for translation, the heightened focus on proactive PMS will naturally result in more data to be translated. Acolad has identified the following best practices to get ready for this tidal wave of content:
Utilize machine translation
Machine translation can help manage the translation volume. All machine translated content should be post-edited by a qualified medical device linguist to ensure quality. For large volumes of complaints, media content or literature reviews, a draft English translation can be quickly generated for further assessment and evaluation of risk and trends.
Deploy translation automation
This starts with the Acolad customer portal for requests that flow through an automated production system. This portal has allowed us to deploy our translation memory and machine translation technology in chained and automated workflows, with integrated linguistic pools. Thus, prepared and pre-translated content can flow easily through our linguistic and review steps.
Try a different approach
A structured content strategy will be necessary to address the need to keep quality/ performance documentation up to date. The old, document-based approach of creating and updating PMS and quality reports as well as technical documentation doesn't easily support control of regulated content, multichannel publishing, and efficient and accurate change management – crucial in the new paradigm presented by MDR.
The solution for long term efficient PMS under MDR is a comprehensive content strategy, supported by structured authoring, content management and content delivery, with integrated automated translation workflow technology. Acolad is already preparing to implement a structured content authoring strategy with some of our clients.
Communicate across departments
There's considerable overlap between the new safety documents and labeling documentation. In fact, entire sections of the SSCP lift out and drop into the IFU. Ensure departments which are traditionally siloed (e.g., Medical Affairs; Regulatory; Labeling; Clinical Ops) are communicating proactively and regularly, to maximize reuse of content across all documentation. This will, in turn, also help with cycle times and translation budgets further downstream. We successfully help bridge collaboration across various departments of our clients.
Following these best practices can lead to efficient and painless PMS compliance for MDR.
Acolad has ample experience supporting our medical device clients to meet the challenges. Contact us for help in your planning and execution.