Introduction

In a recent blog post titled Complying with European In-Vitro Diagnostic Regulation (IVDR) Language Translation Requirements, we described what this is regulation is and its intent.  In summarizing, IVDR mandates that any information accompanying medical devices must be provided in the EU languages accepted in the markets where the device is sold.

When enacted in 2017, the IVDR provided for a transition period ending on 26 May 2024, during which devices covered by certificates issued from 25 May 2017 under the applicable Directives would remain valid for a maximum period of five years after the date of their issuance up to 27 May 2024.

But according to Jones Day, in January 2022 the Council and the European Parliament decided on a general extension of the transition period to 26 May 2025, with longer extensions to 26 May 2026, and 26 May 2027 for certain classes of devices for which the conformity procedure of Directive 98/79/EC did not require the involvement of a Notified Body.  Additionally, a deadline of 26 May 2028 was introduced for certain provisions concerning devices manufactured and used in health institutions.

While this elongated regulatory timeline is helpful from a strict legal perspective, medical device companies should still aim to comply with the language translation requirements with a sense of urgency, as the overriding prerogative and intent of the regulation is one of patient safety.

The Necessity For Urgency

Patient Education

Around two thirds of all clinical decisions are based on information provided by IVD’s.  With patients driving many healthcare decisions these days, opting for customized solutions and personalized approaches, this accelerates the need for manufacturers to be flexible and responsive to their evolving needs.  Patients are also taking more ownership of their health, so getting better access to data and having more insight into the detection of potential issues, treatment plans, and overall monitoring of their health places a burden on the manufacturers to have translated materials in all the countries they are present.

Complying with IVDR regulations related to language translations gives medical device companies a unique opportunity to pro-actively evolve their processes and become an even more helpful part of the patient’s journey.

Notified Bodies Bottlenecks

With IVDR, Notified Bodies (NB) serve as enforcers of the new regulations, and will be required to evaluate most medical devices.  This accounts for approximately 90% of all IVDs, up from about the previous 1%, which will increase NB workloads and decrease NB availability when there is a crush of activity as companies race towards the new compliance deadlines. 

At that time, the decrease in availability of NB’s to review devices, particularly in higher risk classes, will delay product approvals and slow device entry-to-market.  The bottlenecks created by overburdened NB’s with higher workloads could lead to long delays before the review process can even commence, so it is in the medical device manufacturers patient-driven interest to get ahead of this capacity crunch.

Conclusion

Patient focused organizations realize that meeting strict legal deadlines is not the only approach to a wholistic compliance strategy.  In matters of safety, such organizations know that prioritizing compliance efforts takes precedence to any delays in implementation of regulatory directives.  This is especially true with the IVDR given the many languages spoken across the EU, and the importance of information provided by device manufacturers for patients. 

It is obvious that implementing the language translation requirements in the IVDR is a must-do on an accelerated and pro-active basis.

Click here to learn how Language Scientific  is uniquely qualified to handle IVDR translation requirements.