On 23 January, the European Commission published another proposal to amend (EU) 2017/746 on In Vitro Diagnostic Regulation (IVDR). They proposed:
- A further extension of the transitional provisions for certain In Vitro Diagnostics (IVDs). The intent is to reduce the risk of shortages of certain products, such as high-risk IVDs. These are used, for example, to test for infections in blood or organ donations and for blood grouping in transfusions.
- A phased implementation of the finalized electronic systems within the European Database on Medical Devices (‘EUDAMED), rather than waiting until all six modules are completed before mandating EUDAMED’s use.
The proposal reinforces the concerning reality of high-risk device shortages in Europe. In an October 2022 review, there were 1,551 valid certificates issued by Notified Bodies under Directive 98/79/EC. With the original transition in progress, certificates are beginning to expire (38 in 2022 and 165 in 2023)–482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May). The proposal also seeks to require manufacturers to provide advance notice when they plan to halt the supply of essential medical devices and IVDs. A new Article, 10a, is introduced to set out this obligation.
Interruption Obligations in Supply of Certain Devices
The proposal aims to impose an obligation on manufacturers to inform their relevant competent authority, health institutions and distributors before they cease, temporarily or permanently, the supply of a critical device. This aligns with concerns that device availability may not be guaranteed during the IVDR transition periods. Manufacturers will need to provide this warning six months in advance so national authorities and healthcare providers have sufficient time for mitigation measures to ensure patient safety and a high level of public health.
Where is This Coming From?
At the end of October 2023, manufacturers had submitted 1,378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by Notified Bodies across all risk classes. For class D IVDs, only 335 applications were submitted and 117 certificates were issued. This is especially concerning since it is estimated over 1,000 devices are in Class D alone, and we can expect around 15,000 certificates to transition to IVDR for other risk classes. The slow transition to IVDR has been a combination of a lack of scientific, technical and regulatory expertise. The COVID-19 pandemic and limited capacity at all levels—including manufacturers and the mere 12 Notified Bodies designated under IVDR—have led to fewer applications and a delay in certificates issued.
Transition Periods
The proposed transition periods, dependent on the risk classes of the devices under the IVDR (Annex VIII), are:
- 31 December 2027, for IVDs covered by a certificate that was issued in accordance with Directive 98/79/EC and for Class D devices
- 31 December 2028, for Class C devices
- 31 December 2029, for Class B and Class A sterile devices
Extended Transition Period Conditions
In a similar approach to Regulation (EU) 2023/607 for the MDR, manufacturers actively taking the necessary steps to ensure their devices’ safety and transiting to the new rules will benefit. Furthermore, extended transitional periods only apply to ‘legacy devices’—those covered by a certificate or declaration of conformity issued under Directive 98/79/EC (IVDD) before 26 May 2022. The conditions include:
- A Quality Management System (QMS) in accordance with IVDR Article 10(8) is in place no later than 26 May 2025
- A device complies with Directive 98/79/EC (IVDD) and does not undergo significant changes (such as design or intended purpose)
- The devices do not present an unacceptable risk to the health or safety of patients, users, other persons or public health
- A manufacturer (or authorized representative) submits an application to the Notified Body to transfer the device to the IVD Regulation by 26 May 2025 (Class D), 2026 (Class C) or 2027 (Class B and A sterile IVDs), followed up by a written agreement within four months
EUDAMED: Gradual Roll Out
To date, three EUDAMED modules have been available for voluntary use: Actors (since December 2020), UDI/Devices (October 2021) and Notified Bodies/Certificates (October 2021). However, further modules (market surveillance, post-market surveillance and vigilance) are expected to be completed in Q2/2024. The last module (clinical investigations/performance studies) will not be completed until Q3/2026, at the earliest. The proposal aims to allow users access to completed sections of EUDAMED by late 2025.
NAMSA Expert Insight
This proposal intends to allow manufacturers of certain legacy IVDs more time to transition from the IVD Directive 98/79/EC to the IVDR 2017/746. Some conditions will need to be followed, such as having a QMS in place. Furthermore, it is pertinent not to forget that as of 26 May 2022 the IVDR requirements relating to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices already apply. Manufacturers with new devices must submit directly for IVDR.
How Can NAMSA Help?
At NAMSA, we understand the challenges and complexities of the transition from IVDD to IVDR. Our team of experts is comprised of seasoned IVDR professionals with extensive experience in guiding IVD developers through the compliance journey.
Our comprehensive services encompass every aspect of the IVDR transition, from initial assessment to application preparation, submission and conformity assessments. We are committed to facilitating a smooth and timely transition for your IVD devices. With NAMSA by your side, you can rest assured that your compliance needs are in capable hands.
Don’t let time slip away. The IVDR transition is not just an obligation; it’s an opportunity for growth and sustainability in the European market. Contact NAMSA today and let us be your trusted partner on the road to IVDR compliance. Your success is our mission, and your future in the IVD industry is our priority.
Warren R. Jameson, PhD
Over 15 years experience in IVD research, development, manufacturing, regulatory affairs and quality management. Served in Research and Development as well as Quality and Regulations Manager ensuring compliance with legislation, managing quality documentation, risk assessment, risk management and audits. Expert in reviewing technical files and guiding IVD sponsors for IVDR compliance. Creating technical documentation such as Performance Evaluation Plans (PEP) and Reports (PER) for IVD devices to be used as part of technical file submissions for IVDR compliance and to carry out performance evaluation. Significant experience in gap analysis reviews of analytical performance and clinical performance data and determination of the data is to the latest guidelines for performance, acceptable to IVDR standards and advise on solutions. Clinical performance creation including review of clinical performance protocol, studies and literature to determine the needs of devices and any gaps for IVDR compliance or US submissions. Scientific Validity report creation with search and review of scientific literature for analyte link to pathological or physiological conditions as stated in the IVDR for legacy and novel devices.