IVDR Deadlines: All Key Dates for Legacy and Non-Legacy IVDs
The in vitro diagnostic medical device (IVD) industry is going through a challenging transition phase, marked by the IVDR Regulation (EU) 2017/746, which came into force on May 26, 2022, replacing Directive 98/79/EC (IVDD).
The new Regulation introduces more stringent requirements and reflects the technological evolution of the last twenty years. The aim is to ensure a robust, transparent, and sustainable regulatory system that maintains high standards of safety and performance and promotes innovation.
Article 110 of the IVDR provides for transitional arrangements to facilitate a smooth transition. However, due to the numerous difficulties encountered during the implementation phase of the Regulation, the IVDR deadlines were repeatedly modified and extended for Legacy IVDs, to ensure continuity in the supply of essential devices and avoid shortages on the European market.
In particular, the Regulation (EU) 2024/1860 published in the Official Journal of the European Union on July 9, 2024, introduced important innovations.
As we will see in the course of this article, fundamental IVDR deadlines are approaching that IVD manufacturers can no longer ignore.
Transitional Provisions for Legacy Devices
Legacy IVDs can continue to be placed on the market until certain expiry dates, which vary according to risk class and compliance with specific conditions.
An exception to this is non-sterile Class A IVDs, which did not require the intervention of a Notified Body under Directive 98/79/EC (IVDD) and were already required to comply with the IVDR Regulation as of May 26, 2022, with no possibility of extension.
Requirements for extending the transition period of Legacy IVDs
As defined in Article 110, para. 3 of the IVDR Regulation, in vitro diagnostic Medical Devices placed on the market with a valid certificate according to Directive 98/79/EC (IVDD) before May 26, 2022, are considered Legacy IVDs.
To fall into the category of Legacy devices, all the following requirements must be fulfilled:
- be covered by a valid EC certificate or declaration of conformity issued according to IVDD before May 26, 2022;
- Have not undergone significant changes in design or use during the transition period;
- Do not present unacceptable health and safety risks.
To benefit from the extension, manufacturers must:
- Ensure compliance with the QMS by May 26, 2025: each legacy device manufacturer must ensure full compliance with its Quality Management System according to the IVDR Regulation (EU) 2017/746 (requirements of Article 10(8)). This obligation applies to all Legacy IVDs, regardless of risk class. Without this compliance, it will not be possible to benefit from the extended deadlines.
- Apply for certification to a Notified Body (NB) within specific deadlines, listed below, depending on the risk class.
- Enter into a contract with the NB within further defined deadlines, depending on the risk class.
Deadlines for application and contract with the Notified Body
- Class D Legacy IVD:
– Request for conformity assessment to a Notified Body: by May 26, 2025
– Contract with the Notified Body: by September 26, 2025
– IVDR certification: by December 31, 2027 - Class C Legacy IVD:
– Request: by May 26, 2026
– Contract: by September 26, 2026
– IVDR certification: by December 31, 2028 - Class B and Class A sterile Legacy IVDs:
– Request: by May 26, 2027
– Contract: by September 26, 2027
– IVDR certification: by December 31, 2029
IVDR Calendar: Summary Table of IVDR Deadlines
IVD previously self-certified according to IVDD: Watch out for the end of the IVDR transitional period!
Many devices that in the past could be placed on the market by self-certification according to IVDD (e.g. class A devices or others not subject to ON), now fall into a higher risk class according to IVDR and therefore require the intervention of a Notified Body.
For these devices, the extension is not possible, even if they had a valid declaration of conformity according to IVDD, as they do not fall under the definition of ‘Legacy IVD’.
What are the rules for Non-Legacy IVDs?
IVDs that are not considered Legacy devices must be fully compliant with the IVDR as soon as they are placed on the market.
In particular, IVDs are excluded from the transitional regime if:
- They are not covered by a valid EC certificate or declaration of conformity under Directive 98/79/EC (IVDD) issued before May 26, 2022;
- They do not meet the requirements defined for legacy IVDs (e.g. significant changes, QMS non-compliance, no contract with NB);
- They must undergo conformity assessment by an NB according to the new IVDR classification;
- They were previously self-certified according to IVDD, but now, based on reclassification according to IVDR, require the intervention of a Notified Body.
Conclusion
The complexity of IVDR deadlines requires careful planning and strict adherence to timelines by manufacturers.
Manufacturers of legacy devices that fall under the transitional regime can still benefit from extensions, but must accurately meet the IVDR deadline for the application and contract with the Notified Body, as well as demonstrate compliance with the QMS by May 26, 2025.
New IVD devices, on the other hand, are not eligible for the transition period and must already be fully IVDR-compliant when they are placed on the market.
Regulation (EU) 2024/1860 has further updated the regulatory framework, making a proactive approach to compliance essential to ensure the continued marketing of its in vitro diagnostic Medical Devices.
>>> Complife experts are on hand to offer comprehensive support in complying with the IVDR Regulation (EU) 2017/746.
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