The Medical Device Coordination Group released a new guidance document:
MDCG 2022-8: Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
It provides guidance on which aspects of the IVDR apply to ‘legacy’ and ‘old’ devices.
Even though the full implementation of the IVDR is staggered per the dates bulleted below, some aspects of the IVDR become applicable to all IVDs starting 26 May 2022.
Therefore, you need to know which parts of the IVDR to immediately incorporate into your device technical documentation files and quality management system.
Note that Class A non-sterile (‘self-certified’) IVDs are not eligible for the IVDR progressive rollout, and compliance with the IVDR becomes mandatory on 26 May 2022.
Devices with valid Notified Body issued IVDD CE marking certificates are also considered legacy devices and may continue to be placed onto the European market until they expire or 26 May 2025, whichever date is first.
The guidance document confirms the transition dates and outlines which sections of the IVDR do and do not apply to legacy devices.
Last date by which legacy IVDs may be placed onto the market
For example, if your IVD was previously self-certified under the In Vitro Diagnostics Directive (IVDD) 98/79/EC, but is now Class C under the IVDR, you may continue to place the IVDD CE marked device onto the European market until 16 May 2026. Any products placed onto the market after this date, must have IVDR CE marking.
Conditions apply. For more information, please read: What are Legacy Devices?
For more information on deadlines, please read: Placing on the Market – Definition and Cutoff Dates
Last date by which legacy IVDs may be put into service (i.e., sell-off date)
What is the impact of the IVDR on ‘old’ devices?
Old IVD devices are those that were placed on the market or put into service before 26 May 2022. Old devices are already in the European distribution chain, or with the end user, before the IVDR’s date of application.
The MDCG guidance states that the IVDR is generally not applicable to old devices. However, some aspects do apply.
Specifically, IVDR market surveillance activities may apply to old devices. The reason is because:
“This allows competent authorities to check that those devices are in conformity with the rules applicable at the moment when they were placed on the market and to take appropriate measures against non-compliant or unsafe devices.”
Further, reporting and analysis of serious incidents and field safety corrective actions that occur after 26 May 2022, should be done in accordance with the IVDR (Art. 82 & Art. 84).
Applicable IVDR Sections
The below table is not comprehensive. We recommend reviewing the Annex (page 8) of MDCG 2022-8 to confirm the full table of items.
| Requirement | Applicable to Legacy IVDs? | Note |
| Person Responsible for Regulatory Compliance (PRRC) | NO | Art. 15 |
| Summary of Safety and Performance (SSP) | NO | Art. 29 |
| Post market surveillance (PMS) System & Plan | YES | Art. 78, 79
Requirements include a Post-Market Performance Follow-up (PMPF) plan according to Annex XIII Part B; however, with exception of requirements that relate to non-applicable obligations, e.g. Art. 78(3)(d) – Summary of safety and performance; there is no requirement for a full revision of the technical documentation in accordance with Annexes II and III) |
| Post-market Surveillance (PMS) Report | YES | Art. 80
Applicable to all ‘legacy devices’, unless manufacturer voluntarily prepares a Periodic Safety Update Report (PSUR) pursuant to Article 81 |
| Periodic Safety Update Report (PSUR) | NO | Art. 81 |
| Trend reporting | YES | Art. 83
Note: Trend reporting was already part of the vigilance system established under the IVDD |
| Analysis of serious incidents and field safety corrective actions (FSCAs) | YES | Art. 84 |
Until EUDAMED is fully functional, the registration requirements under the IVDD prevail and must be followed.
Although EUDAMED is currently voluntary, industry is encouraged to use the system early, and not wait until the last minute to register.
For more information about EUDAMED, read: EUDAMED Basics
2025 … 2026 … 2027
Do these dates seem like the distant future?
Perhaps, but don’t forget: you need to plan on a 6-8 months waiting period to engage a Notified Body, and another 12-18 month timeframe to obtain CE marking. That already pushes those dates forward by ~2+ years.
We are at the eve of IVDR implementation and there are only seven notified bodies designated to the IVDR. With a massive number of IVDs now requiring notified body certification by 2027, timeframes are unlikely to get any shorter.
