Most of the IVDs marketed in the EU are legacy devices. This means they can be marketed under the former In Vitro Diagnostic Devices Directive (IVDD) along with the transitional provisions in EU IVDR Article 110(3) until the final transition deadline for CE Marking under the IVDR. The European Commission’s initial intention was to bring all IVDs under the IVDR after a five-year transition period by the date of application (26 May 2022). However, several amendments were implemented that introduced additional transitional provisions but only under specific conditions.  

Some of these specific conditions include:

• The device was placed on the market before 26 May 2022 in accordance with Directive 98/79/EC.

• There should be no significant change in device design or intended purpose.  

• The manufacturer must comply with basic Quality Management System (QMS) obligations addressed in IVDR Art (10).  

• Legacy devices must also be registered in EUDAMED (see MDCG 2019-5).  

• If the device does not have a Basic UDI-DI or an UDI-DI, they must have EUDAMED DI and EUDAMED ID.  

The detailed obligations are defined in MDCG 2022-8, Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices.’ If you are a legacy IVD manufacturer, it is essential to understand and comply with all provisions throughout the transition timeline. Failure to do so could jeopardize your standing in the EU.

IVDR post-market requirements that apply during transition

Many legacy devices, even high-risk IVDs, were held to minimal requirements under the IVDD. However, legacy device manufacturers may not be aware they are obligated to certain aspects of the IVDR during the transition period, particularly regarding post-market compliance.

IVD manufacturers and their economic operators are forced to comply with IVDR post market surveillance, registration, and vigilance reporting activities (incident, FSCA, FSN). For example, a Post-Market Surveillance Plan (PMSP) and a Post-Market Surveillance Report (PMSR) are required as well as a Post-market Follow-up Plan (PMPF) and a Post-Market Follow-up Report (PMPR), if deemed applicable. Post-market activities should include compliance with trend reporting, per EU IVDR Article 83. Though no official PMPF templates have been published by the European Commission for IVDs, they might be structured in consideration of MDCG 2020-7 and MDCG 2020-8 for medical devices.  

IVD legacy devices do not require the involvement of a Notified Body for CE marking yet, but still need to be compliant with certain aspects of the IVDR, and need to meet applicable EU regulations such as REACH, RoHs, WEEE, etc.  

Legacy devices are subject to some regulatory oversight, as well. All IVD legacy device manufacturers may not be aware they are eligible for announced or unannounced audits by national competent authorities at any time. Even non-EU IVD manufacturers could be audited through the mandated European Representative. Therefore, situations could arise in which IVD companies unexpectedly find themselves under a microscope.  

For example, if a customer complains about an IVD to a local authority, the authority will launch a formal process by requesting the IVD manufacturer’s records in the forms required under IVDR (e.g., obligations from IVDR Article 82, addressed in MDCG 2023-3 Rev. 2 replacing MEDDEV 2.12-1).  

Another example is the compliance with EU safety regulations, which can be important for IVDs because the required safety or compliance symbols appear on the outer and/or inner labeling, or safety documents that must be included in the shipment (e.g., Safety Data Sheet, SDS). This is routinely checked at the border by customs and could initiate the same formal process with the responsible authority for IVDs. If the information is not adequate, the authority will request the manufacturer's current IVDR-compliant QMS procedures, Technical Documentation, and evidence that these are legacy devices. If objective evidence is not provided, this could halt the manufacturer’s marketing operations in the EU, open a FSCA or recall, and could also result in significant legal actions and fines.  

Maintain IVDR compliance with these steps

All IVD manufacturers who want to remain on the EU market during the transition period need to be proactive. Here is what legacy and non-legacy IVD manufacturers need to do:

• Ensure an IVDR-compliant QMS in line with IVDR Article 10(8) is in place by 26 May 2025. This should include compliance with post-market surveillance, vigilance and registration activities and should consider the obligations of economic operators (distributors, importers).

• Conduct an assessment for the legacy status filed in your Technical Documentation (classification document, registration before 26^th May 2022).  

• Conduct an assessment for (significant or not significant) design changes made to your IVD devices filed in accordance with the interpretation of MDCG 2022-6.

If you are not sure where to start, Pure Global can evaluate your current level of compliance and design a strategy toward upgrading your CE Marking from the IVDD to the IVDR. We will confirm your device’s legacy status, assess your rationale for significant changes to design or intended purpose, and update your QMS documentation to reduce your business risk. Contact us to learn how we can help.

‍