By now, most manufacturers of in-vitro diagnostic medical devices (IVDs) are well aware of Regulation (2017/746/EU) (IVDR) and most are actively working toward compliance. IVDR replaces its predecessor, European Directive 98/79/EC (IVDD), and oversees in vitro devices (IVDs) on the EEA market, comprising 27 countries and 24 languages. Now, under IVDR, manufacturers must provide additional clinical evidence and ensure the accuracy and availability of product documentation and labeling in all 24 EU languages. IVDR also requires manufacturers to follow stricter requirements for IFUs and to translate all operating manuals, marketing materials, patient information manuals, clinical performance information, interfaces for software products, and more.
Why has the European Commission made it exceedingly more challenging for manufacturers to get their IVDs to market? In the broadest sense, the goals set by IVDR are threefold:
1. Align the in vitro medical device industry with technical and medical advances
2. Strengthen clinical safety
3. Create fair market access for manufacturers
Heightened risk classification
The risk classification system under IVDR evaluates the intended purpose of each device and determines the risk to both individual and public health. Unlike IVDD's list-based approach to classification, IVDR uses a rule-based approach. These rules assign each IVD to one of the four risk categories outlined in Article 47 of the IVDR¹:
A: Low individual risk and low public health risk
B: Moderate individual risk and/or low public health risk
C: High individual risk and/or moderate public health risk
D: High individual risk and high public health risk
While manufacturers are able to self-certify for all class A devices (provided they are not sold as sterile devices), devices in classes B, C, and D require conformity assessment by a designated Notified Body (NB). Furthermore, several new rules regarding the classification of substance-based devices have been established. As such, many of these devices will now be reassigned to higher-risk classes.
Increased NB oversight
It is important to note that should your device fall under more than one classification rule, the rule that holds the highest classification will apply. As a result, roughly 80% of all IVDs will now require NB oversight.
To put this into greater focus, "under Directive 98/79/EC, only a relatively small number of high-risk devices (about 8% of all in vitro diagnostics on the market) was subject to notified body control. Under the IVD Regulation, around 80% of in vitro diagnostic medical devices will be under the control of notified bodies, the vast majority of them for the first time."
In other words, to mitigate risks in efficacy and patient safety, all device classes (except nonsterile Class A devices) must receive premarket approval from a designated NB before being placed on the market. This has led to an increase in new documentation now required much earlier on in the process.
Increased scope and volume of content
Much like the Instructions for Use (IFUs) requirements are detailed in Chapter III (23) of the MDR, IFU requirements are laid out in Chapter III (20) of the IVDR. Under IVDR, IFUs (digital or hardcopy) must now be part of an IVD's technical dossier which means IFU translation can no longer be an afterthought. NBs must also audit the Quality Management System (QMS) and technical files of all IVDs (with the exception of Class A non-sterile IVDs). These changes require manufacturers to create additional data and content (including performance studies). Another direct example of this increase involves clinical performance studies. According to a device's newly assigned risk class, manufacturers will now need to conduct clinical performance studies and provide evidence of safety and performance. And, when it comes to Class C and D IVDs, a Summary of Safety Performance (SSP) is now required.
Summary of Safety and Performance (SSP)
Just as the MDR requires an SSCP for Class III and implantable medical devices, the IVDR requires an SSP (Summary of Safety and Performance)⁴ for all Class C and D IVDs.
As a brand new IVDR requirement, the SSP creates an additional layer of confusion for manufacturers already struggling to meet new regulatory obligations. Directly in line with the main objectives of the IVDR, the goal of the SSP is to provide ongoing safety and efficacy transparency for end-users. As such, it must be included as part of the technical documentation. Keep in mind, however, that the creation of the SSP is not a one-and-done affair. It must be updated regularly, especially any time a change to an IVD alters the benefit-risk analysis. What content needs to be provided in the SSP? While NBs currently accept "the requirements in Article 29 of the IVDR as the bare minimum… they also expect manufacturers to go one step further and adapt equivalent SSCP guidance when it comes to stylistic requirements, administrative details, and translation requirements."5
Expansion of product scope
Product scope under IVDR has also expanded. Product scope now includes "diagnostic (including Internet-based) services, genetic testing and other tests that provide information about a patient's predisposition to a specific disease or susceptibility for a medical treatment."6 Manufacturers, therefore, must ensure their website content, in addition to their assessments and technical documents are accurately translated into all official languages spoken in the EU Member States in which their IVDs will be sold.
Increased surveillance and NB designation
This increased volume of content requires an increased number of certified NBs, leading to yet, another industry challenge — a grossly limited number of available NBs. As the European Commission puts it, "with only six notified bodies designated so far under the In Vitro Diagnostic Medical Device Regulation, there is a grave shortage of notified body capacity, making it difficult for manufacturers to conduct the legally required conformity assessment procedures in time."7
In spite of this shortage, however, manufacturers wishing to place their IVDs on the EEA marketplace are still obligated to verify whether or not their NB will be notified under IVDR, and if so, for which products.
Stricter designation criteria
Under IVDR, NBs face much stricter designation criteria, especially when it comes to scientific and technical evaluation competence. NB designation will now involve assessors from national authorities as well as from the Commission and could take upwards of 12 months to complete.
IVD manufacturers (as well as their entire supply chain) now face much greater challenges to meet the new IVDR requirements. The IVDR requires "clear and precise" language regarding all technical documentation submitted to the NB, including patient information materials. The content must be translated into all 24 official EU languages and done so in a way that, regardless of who is reading the content, is clearly understood. And, since no legacy clauses exist under IVDR, all approved IVDs must be reclassified and certified in compliance with the new regulation.
This significant increase in content and translation requirements — along with a shorter timeline (and much earlier on in the process) and a shortage of designated NBs — is forcing manufacturers to carefully rethink their time, resources, and budgets. Partnering with a language service provider (LSP) well versed in life sciences regulatory compliance is one sure way to help manufacturers confidently and efficiently meet these new demands.
Turn to RWS for IVDR compliance and readiness
With over 30 years of experience offering specialized linguistic support for the life sciences industry, RWS knows that high-quality, compliant content is critical for your work at every stage of the value chain. Our industry subject matter experts provide insights and validation regarding the many complex regulations that govern the development and trade of IVDs worldwide.
As regulations continue to evolve, RWS remains one step ahead. Our comprehensive services landscape has been carefully designed to provide our IVD manufacturing partners with greater content control and oversight, leading to global compliance in all target markets. Part of this landscape includes:
- IVDR Compliance Verification
- IFU Analysis and Optimization
- In-country Review Management
- Structured Content Authoring and Management Technology
Simply put, RWS doesn't just keep up to date with the ever-changing regulations and their impact on multilingual content — we stay one step ahead. This is what you expect of us as your trusted partner, and this is what we deliver. We implement strategies to help you streamline and support each stage in a product's lifecycle. No matter your current progress toward compliance, RWS has you covered. Address scalability, accuracy, quality, and compliance across the value chain with an organization you can trust. Let RWS proven content solutions guide you through the complexities of the IVDR compliance journey. Contact RWS to learn how we can support your specific needs.