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.

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.

Multiple Extensions

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.

a) 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.

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 another extension of thirty-one months to the deadline for compliance with IVDR.  This was to deal with concerns that the current timelines would disrupt supply and therefore impact patient safety.  Based on the EC’s history of approval timelines, they found that it can take between thirteen to twenty-four months to certify class D devices.  With this timeline, manufacturers that hadn’t currently applied to a notified body would not be able to comply with 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 ~80% of IVD’s Class B, C or D devices to register with the notified body, compared to less than 10% under the prior IVD Directive 98/79/EC.  The lack of notified body capacity to conduct these assessments means that a high number of these devices would be noncompliant with IVDR, if the previous deadlines were maintained.

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.  There is a lack of transparency regarding the information that will be expected of companies during the certification process, and the timelines for conformity assessments and requirements over the certificate lifetime are often unpredictable and inefficient, posing a financial and resource challenge for companies. There are inconsistencies in the implementation of the regulatory framework, such as variance among the Notified Bodies, as well as variance between official guidance and the legal basis of the regulation.”

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

It is clear that implementation of IVDR is complex, and as unintended consequences such as the ones described in this article come to light, EC authorities are rightfully adjusting timelines with all relevant stakeholders in mind.  While this latest delay of thirty-one appears to be final, we cannot be 100% certain until we get closer to the final deadlines. 

While this elongated timeline is helpful in getting internal matters in order, 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 worst case scenario is one where no internal process changes are implemented and the regulation delays end, what used to be an uninterrupted supply of patient-critical products is adversely affected.  No one wants that to happen.

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.

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