Reasons For Delay In EC Implementation Of The In-Vitro Diagnostic Regulation For Language Translations
Introduction
EU Regulation 2017/746 (IVDR) is a regulation enacted in 2017 for releasing in-vitro medical devices into the European Union. It was published in April ’17 and is closely aligned to the EU regulation on medical devices. In this blog we’ll evaluate the reasons for delay in IVDR regulations.
The IVDR has a significant impact on Medical Devices companies from a language translation perspective, as they initiate clinical trials in one of the EU countries, or when they release a product with its corresponding marketing material into the market. With all such materials, IVDR mandates that any information accompanying medical devices must be provided in the EU languages accepted in the markets where the device is sold.
Learn more in-depth details on the IVDR, and how to comply with the language translation requirements of the regulation.
IVDR Translation: Multiple Extensions
The IVDR, enacted in 2017, set a transition period ending 26 May 2024. Devices with certificates issued after 25 May 2017 under previous directives remained valid for up to five years but no later than 27 May 2024.
a) In January 2022, the Council and European Parliament approved a general transition period extension for IVDR compliance until 26 May 2025. They also granted longer extensions for certain device classes: Until 26 May 2026 and 26 May 2027 for devices that previously did not require a Notified Body under Directive 98/79/EC. Until 26 May 2028 for specific provisions related to devices manufactured and used within health institutions.
b) According to Jones Day, in January 2023 the European Commission (EC) issued a Proposal for a Regulation extending the period during which devices compliant with the old EU legislation on medical devices can continue to be placed on the EU market. The EC also proposed eliminating any “sell-off” restrictions for devices legally placed on the market during the transition time.
c) In January 2024 MedTechDive reported that the EC proposed a 31-month extension for IVDR compliance. This decision aimed to prevent supply disruptions that could impact patient safety.
Historically, EC approval timelines show that certifying Class D devices takes 13 to 24 months. Given this timeframe, manufacturers who have not yet applied to a Notified Body would struggle to meet the May 2025 deadline.
The new deadlines are as follows:
- The deadline for high-risk devices extends till end-2027
- The deadline for medium and lower-risk devices extends to end 2028 and 2029
- Health institutions that manufacture IVD’s in-house now have until May 26, 2030
Reasons For The Delay
Insufficient Testing Capacity
IVDR introduced a new classification system, requiring nearly 80% of Class B, C, and D IVDs to register with a Notified Body—a sharp increase from less than 10% under IVD Directive 98/79/EC. However, the limited capacity of Notified Bodies to handle assessments would have left many devices noncompliant if previous deadlines remained unchanged.
Administrative Challenges
An excerpt from a Position Paper on IVDR published by MedTech Europe states that, “an unpredictable process makes it highly difficult for medical technology companies to adequately plan, prepare, and allocate resources effectively for regulatory clearance, production and communication to their supply chain and end users. Companies face a lack of transparency regarding expected certification requirements, assessment timelines, and certificate lifespan. These uncertainties create financial and operational challenges. Additionally, inconsistencies in implementation arise from variations among Notified Bodies and discrepancies between official guidance and regulatory law.
Notification Complexity
The EC is requiring manufacturers to give prior notice if they foresee an interruption to the supply of IVDs or medical devices. A number of advocacy organizations have petitioned for this notification process to be radically simplified and managed at the EU level, and not within each country. This is a recommendation that the EC authorities are analyzing in detail, with changes to the process expected.
Conclusion
The IVDR implementation remains complex, and as unintended consequences emerge, EC authorities continue adjusting timelines to accommodate all stakeholders. While this latest 31-day delay appears final, certainty will only come as the deadline approaches.
Although this extended timeline allows companies to finalize internal processes, they must still urgently comply with language translation requirements. The regulation’s primary goal remains patient safety.
The worst-case scenario occurs if companies delay internal changes and regulation deadlines take effect. This could disrupt the supply of critical medical products, a situation no one wants.
Language Scientific is uniquely qualified to handle IVDR translation requirements.
- Check out this short video to learn more about our translating expertise.
- Contact Us so we can help you become IVDR compliant as soon as possible.
