No matter how we feel about government regulations, they are here to stay and are perpetually changing. This is especially true in the life sciences arena within the European Union (EU). While the latest medical device and in-vitro diagnostic regulations (MDR/IVDR) aim to strengthen patient safety and company transparency, they can quickly become a burden to medical device companies not fully prepared to implement the necessary changes. Regulations affect how medical device companies structure their respective businesses as well as their internal workflows and external partnerships. In other words, as these latest regulations continue to evolve, they have the potential to complicate an already complex compliance process. But they don't necessarily have to.
The following article lays out the ever-changing regulatory landscape from a linguistic standpoint and provides a clear path forward.
The current regulatory landscape
With hundreds of thousands of medical devices and in-vitro diagnostic medical devices circulating within the EU marketplace, there is good reason for new regulations to push for the highest-possible safety and quality standards across the board. But safety and quality don't happen in a vacuum. As with most things in life, safety and quality must involve effective communication. What this means, of course, is increased volumes of content that are now required much earlier on and throughout the entire product lifecycle. What it also means is that the increased volumes of content will need to be translated into the official language(s) in which each device will be marketed — up to as many as 24 languages.
Increased volume of content
In addition to new requirements to update and revise existing technical documentation, there are now increased requirements for more detailed labeling and packaging, product description, clinical data, document analysis, and marketing content, as well as increased documentation required for authorization and distribution. It is of no surprise that this increase has led to greater internal and external logistical challenges.
Translations earlier in the process
Timing has also been an issue for medical device manufacturers. Under the previous regulations, translations did not require completion until after CE marketing was granted. Now, however, under MDR, translated content for instructions for use (IFUs) and labeling must be completed much earlier in the process and must be submitted for review by the respective notified bodies (NBs). In other words, companies must now coordinate and plan their required translations much earlier in the workflow.
Clearer, more precise translations
All translated content — especially for IFUs, labeling, and clinical performance data — must be precise, unambiguous, and written in such a way that it is clearly comprehensible to the intended user or patient. These new requirements have compelled companies to create more stringent processes with regard to translation and linguistic validation.
Expanded range of regulated medical devices
Under the new MDR, medical device classification has been extended to include many products without an intended medical purpose. The list of devices concerned is found in Annex XVI of the MDR. Expanding this classification has, in turn, created a significant increase in products that now must adhere to the new regulations.
Increased focus on supply chain transparency
LSPs need to have a highly effective and compressive Quality Management System that takes a risk-based approach to decision making and management of third-party suppliers. Therefore, ISO 13485 certification is critical here — not to mention mandatory — to demonstrate regulation compliance.
Ongoing changes to the regulatory landscape — is MDR/IVDR beginning to align with pharma regulations?
The European Union is home to one of the most highly regarded pharmaceutical regulatory systems in the world. As such, the European Medicines Regulatory Network consists of closely coordinated partnerships between national competent authorities, the European Commission, and the European Medicines Agency (EMA). The EMA "operates at the heart of the network, coordinating and supporting interactions between over fifty national competent authorities for both human and veterinary medicines." In addition to managing all applications for European Marketing Authorisation Applications (MAAs), the EMA also manages the scientific evaluation of all medicines intended for use in the EU.
This highly sophisticated network recognizes and respects its responsibility to protect its citizens. With this as its central focus, for over two decades, it has developed and maintained stringent and complex requirements to which pharmaceutical companies must adhere. From development and manufacturing to promotion, distribution, and ongoing monitoring, the network is responsible for quality, safety, and efficacy of all medicines in European market circulation. And it is here — at the intersection of quality, safety, and efficacy — where the latest medical device and in-vitro diagnostic device regulations are starting to align themselves with these robust pharmaceutical regulations. But requirements under MDR and IVDR are, in all likelihood, going to continue to evolve. By paying close attention to the similarities (as well as the differences) between pharma regulations, MDR, and IVDR, medical device companies can better position themselves ahead of the curve.
Overlapping of medicines and medical devices
Having established the Single Market through a standardized system of laws, the EU strives to maintain its commitment to quality, safety, and efficacy across pharma, medical devices, and in-vitro diagnostics. And while the EU maintains strict definitions that identify a medicinal product from a medical device, there are times when these definitions overlap. Learning how to recognize which regulatory framework applies to these borderline products can cause some confusion for both pharmaceutical and medical device companies.
As an example, consider an MRI scan that sometimes needs to have a dye injected into the patient's body. In the past, the device was marketed under conformity without requiring separate evaluation of the actual dye that was injected. Now, however, under IVDR, the chemical, which is considered a drug, may need to be subjected to the pharmaceutical Centralised Procedures, while the actual device would go through almost a secondary assessment alongside it. Because of this, we might very well find in-vitro companies involved in a much more complex regulatory world. Depending on the overlap of the medicinal product and the medical device itself, in-vitro companies that were never before exposed to the pharma side of regulations would likely now have to take an active role in carrying out a full-blown pharmaceutical Centralised Procedure in addition to fulfilling the requirements imposed by IVDR.
Economic operator translation and repackaging obligations
Unlike the regulations of the past, the latest regulations now clearly define who the economic operators are. Essentially, two economic operators — manufacturers and importers — each have their own respective obligations although some obligations overlap. Both, for instance, must ensure all labeling is compliant before placing a medical device on the EU market and this includes the responsibility of ensuring proper translations are in place. It is also important to recognize that "[i]n accordance with Article 16(4), importers and distributors performing [relabeling] and/or repackaging activities should:
- Inform the manufacturers of the intention to make the [relabeled] or repackaged device available on the market, at least 28 days prior to making the device available on the market and;
- Upon request, provide the manufacturer with a sample or mock-up of the [relabeled] or repackaged device, including any translated label and IFU[Source]."
More complex content management
Under the latest regulations, medical device companies must update all their existing documentation which requires a considerable amount of effort and, for many, causes some confusion. Consider a company that has been marketing their medical device within the EU for a decade but now must update all of their content in order to comply and ensure their product not only fits in to the new templates but uses the correct terminology. It might even be that a particular device never had the right level of scientific evidence or clinical evidence to begin with. In such a case, (even though the product has been in circulation for 10 years) the EU might now decide that it must be removed from circulation unless the company carries out certain clinical tests or can prove (through post-market surveillance) that no safety or efficacy issues have arisen. Even if the company can prove all of this, however, it still doesn't take away the fact that the company must still update its IFUs and must now create the Summary of Safety and Clinical Performance (SSCP).
Medical device companies such as these are suddenly finding themselves faced with difficult decisions to make — will you continue to get your accustomed ROI after investing in all of these updates? Will you continue to meet your sales goals? Some companies might decide to drop certain devices and focus exclusively on their big-ticket products. Others, however, will decide to go through the entire regulatory process. Either way, the new and ongoing regulations will undoubtedly change the playing field for all.
Under these new and ongoing procedures, there are now document templates that need to be strictly followed. One in particular is the SSCP mentioned above. The new regulations now hold manufacturers responsible for writing the SSCP in a way that intended users and patients alike can easily understand. This could potentially double the translation workload for the same document — one, for example, intended for the healthcare practitioners and therefore, written in scientific terms, and one intended for the patients written in layperson's terms.
Along with these new document templates, however, there are accompanying mandated terminology challenges. Depending on what stage of the process a company is at, they might have to submit different documents and different product information. On the pharma side, for instance, you could very well have one sentence in English, that, depending on the document, might need to be translated differently. That alone, makes the likes of a glossary very challenging since the same terms are not always translated in the same way (depending on how and where the content is being used, for example). By default then, the likes of TMs would also be very difficult to implement since there is arguably never an exact translation correlation — it just isn't that straightforward. Should MDR and IVDR continue to further align with pharma, there is a strong probability that these same additional challenges will soon manifest themselves.
Moving toward digitalization
Whether for version control, marketing collateral, or internal and interdepartmental documentation, new technological solutions are taking hold at what feels like a rapid pace across industries. And while we certainly see this trend beginning in the medical device sector, technology poses a number of unique challenges in the current workflow. To put this into clearer perspective, under the latest regulations, the EU mandates highly complex content management (as noted above) all the way down to content formatting and layouts. To date, however, they have only accepted submissions in PDF or Word format, greatly slowing down workflow processes.
Nonetheless, the EU is trying to modernize and digitize their own workflows. In so doing, they will, in all likelihood, eventually move away from Word and toward XML files. In fact, within the next 1 -2 years, companies will likely have to submit electronic product information (ePI). When that time comes, if you've partnered with RWS — and your content is in our proprietary Content Management System (or our TM) — we'll have it ready for you.
How we can help
RWS is in the unique position of having worked for years with regulatory affairs for the pharmaceutical industry. Our processes for pharmaceutical content management are well established, allowing us to see how regulations for the medical device sector are starting to resemble that of pharma. With our decades of expertise behind us, RWS has developed and maintained sophisticated workflows and processes as well as advanced standard operating procedures (SOPs) managed by our specialized production team. In short, RWS offers what our competitors cannot — a completely unique service. We've gone through the pain over the past few years to bring you our pharmaceutical Centralized Procedure content management process that can simply adapt to fit in with the latest (and evolving) MDR and IVDR.
One of the most common themes in business today is change, and this is certainly true for the medical device sector. By partnering with RWS, we'll give you the tools and the ability to confidently tackle these new and ongoing changes in the medical device industry. Let us help, and together, we'll get you on the road to full compliance.