In January 2022, Regulation (EU) 2022/112 extended the transitional provisions of Regulation (EU) 2017/746 regarding the In Vitro Diagnostic Regulation (IVDR), in particular to article 110(3). This law proposed a progressive roll-out of the Regulation to prevent disruption to the supply of IVD products in relation to the COVID-19 Pandemic.
In May 2022, two new guidance documents were released by the Medical Devices Coordination Group (MDCG) to allow a more precise interpretation of article 110.
- This document provides guidance on how the significance of legacy product changes should be evaluated after the date of application of the IVD Regulation (EU 2017/746), the 26th of May 2022.
- Please refer to NAMSA Blog Post, “MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity” for further information.
- This document provides guidance as it relates to the applicability of IVDR requirements to “legacy” and “old” devices.
The MDCG 2022-8 is probably one of the most important IVDR guidance documents that has been published in recent months as it finally clarifies what requirements are/are not applicable to legacy IVDs post-IVDR Date of Application (26 May 2022). Specifically, this guidance provides information on:
- Application of requirements set out in Chapter VII of the IVDR for post-market surveillance, market surveillance and vigilance to “legacy devices”
- Application of other IVDR requirements for “legacy devices”
- Application of IVDR requirements for devices placed on the market prior to 26 May 2022 (“old devices”)
1. Definition of a “Legacy Device”
The following terms are defined in the MDCG 2022-8 guidance:
- “Old devices” are IVDD devices placed on the market, or put into service, before the DoA (26 May 2022) in accordance with the IVDD or the applicable national rules before the IVDD became applicable, and that are still on the market or in use after 26 May 2022.
- “Legacy devices” are IVDD devices that are placed on the market, or put into service, after the DoA (26 May 2022), and until the end of the respective transition period if the conditions laid down in the first subparagraph of Article 110(3)3 are fulfilled.
“Legacy devices” can be:
- Devices covered by a valid EC certificate issued by a Notified Body (NB) in accordance with Directive 98/79/EC In Vitro Diagnostic Directive (IVDD) prior to DoA, and may be placed on the market or put into service until 26 May 2025.
- Devices for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD, and for which the conformity assessment procedure pursuant to the IVDR (contrary to the IVDD) requires the involvement of an NB and may be placed on the market or put into service until the following dates:
Class D Devices: 26 May 2025
Class C Devices: 26 May 2026
Class B Devices: 26 May 2027
Class A Devices (placed on market in sterile condition): 26 May 2027
These dates apply provided that the devices continue to comply with Directive 98/79/EC, and there are no significant changes in the design and intended purpose of those devices.
- “IVDR devices” are devices that are placed on the market as being in conformity with the IVDR other than ‘legacy devices’.
2. Impacts to IVD Manufacturers
Why would the authors of the MDCG 2022-8 deliberately separate out “old devices” versus “legacy devices?”
- Regulators are imposing many more IVDR requirements for “legacy devices” compared to the “old devices,” so there are notable differences.
- For IVD manufacturers that have placed products on the market before the DoA and did not intend to transition these products under the new regulation, the regulators point out that they are not exempt from applying certain IVDR requirements to these products.
3. Application of IVDR Requirements to “Old Devices”
One would assume that IVDR requirements would not be applicable to ‘old devices.’ Nevertheless, based on the following statement, regulators segued the requirements of the IVDR to old devices: “IVDR provisions should generally apply if they do not directly impact the device, its documentation or the conditions for the placing or making available of devices on the market.”
This implies that many requirements set out in Chapter VII of the IVDR on post-market surveillance, market surveillance and vigilance will not apply to ‘old devices’ such as PMS/PMFP plans, but the following does apply:
- Article 82 and 84 for the reporting and analysis of serious incidents and field safety corrective actions occurring after 26 May 2022
- Article 88-95, with respect to market surveillance activities by Competent Authorities
This allows Competent Authorities to perform appropriate checks on the conformity of these devices and to take appropriate measures against non-compliant or unsafe products. Logically, the conformity of these devices will be checked against the rules applicable at the moment when they were placed on the market (i.e. IVDD).
4. Application of IVDR requirements to “Legacy Devices”
Per Article 110(3) IVDR, the relevant requirements set out in Chapter VII of the IVDR on post-market surveillance, market surveillance and vigilance apply to “legacy devices.” This means that the following applies:
- Articles 78 and 79: PMS plan
- Annex XIII, Part B, IVDR: PMPF requirements as part of the PMS activities to “proactively collect and evaluate performance and relevant scientific data from the use of a device”
- Articles 82, 83 and 84 IVDR, for the reporting and analysis of serious incidents and field safety corrective actions and trend reporting.
- Article 80: PMS report
Regulators also took into account that not all NBs responsible for monitoring legacy devices are designated under the IVDR and therefore, some flexibility is allowed. The ‘appropriate surveillance’ activities conducted by an NB in accordance with the IVDR will essentially be a continuation of the previous surveillance activities under the IVDD, while placing on top the new requirements resulting from the transitional provisions.
Some important takeaways of the MDCG 2022-8 for manufacturers of legacy devices that should be noted are:
- Aspects related to pre-market requirements are not applicable, which means that manufacturers do not have to:
– Update the summary of safety and performance (SSP)
– Draw up, retrospectively, a performance evaluation report
- PSUR pursuant to Article 81 is left to the discretion of the manufacturer on a voluntary basis.
It is important to note that ‘provisions on performance studies apply to studies started after 26 May 2022 regardless of the device’s status.’
Contrary to what one might have thought, “legacy devices” are subject to just more than the usual PMS and vigilance requirements. As defined by the guidance document, and mapped in the Annexes, many IVDR requirements related to Quality Management Systems (QMS) elements and economic operator requirements now also flow over into “legacy devices” as part of the transition provisions.
“Legacy devices” are subject to the IVDR registration requirements with some exceptions such as the assignment of a Basic UDI-DI and a UDI-DI. On the other hand, the registration of devices and economic operators is required. The MDCG 2019-5 provides guidance on registration of legacy devices in EUDAMED.
While this long-awaited guidance clarifies the IVDR requirements applicable to both old and legacy IVD products after 26 May 2022, manufacturers should bear in mind that there may be other guidance to come.
How Can NAMSA Help?
At NAMSA, our European regulatory team can help guide you through this complex regulatory environment and help determine the correct regulatory pathway for your IVD product. We not only understand how to accurately interpret the complicated regulatory challenges that IVD manufacturers sometimes face, but we also help you simplify the development and implementation of effective development strategies. Whether supporting IVD regulatory assessments and submissions, developing IVDR compliant technical files, designing and managing clinical trials or building ISO 13485:2016 and 21 CFR part 820 compliant quality systems… we’ve got you covered.
To learn about NAMSA’s full suite of IVD services and solutions, including IVDR compliance planning, please visit: https://namsa.com/services/ivd/. Or, if you’re ready to set up a complimentary consultation, get in touch with one of our IVD experts here: https://namsa.com/namsa-expertise/subject-matter-experts.
 ‘placing on the market’ means the first making available of a device, other than a device for performance study, on the Union market.
 ‘putting into service’ means the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.
Christèle East, PhD
Christèle currently serves as a Senior Regulatory Consultant (IVD) at NAMSA. She has been in the MedTech industry for over 20 years with 10 years focused on IVD products. She gained experience on IVD product development in small biotechnology companies, including AmikanaBioLogics and HalioDx. Before joining NAMSA, Christèle worked for nexialist, a consulting company specializing in regulatory intelligence and compliance of health products. As a Medical Device and IVD consultant, she was involved in ensuring compliance with classification, technical documentation for CE marking, performance evaluation within the framework of IVDD and IVDR, regulatory support; and biological risk assessment (plan & report), clinical evaluation and PMS for Medical devices. Christèle obtained her PhD in Cellular Biology from University of Joseph Fourier, Grenoble (France). After several years working on the development of IVD products, she completed a University Diploma in Clinical Research at the Faculty of Medicine of Marseille.