IVDR Explained: Classification, Transition Deadlines and In-House Tests

The In Vitro Diagnostic Regulation changed the economics of diagnostics before it changed anything clinical. Under the old directive the great majority of in vitro diagnostic devices were self-declared by their manufacturers. Regulation (EU) 2017/746, which applied from 26 May 2022, replaced that with a four-class risk system in which most devices require notified body involvement — and the supply of notified body capacity has been the binding constraint ever since.

What the classes mean

IVDR sorts devices into classes A to D, with D the highest risk. The Commission’s own examples place HIV and hepatitis tests in class D and certain cancer tests in class C. Class A covers the lowest-risk products, and class A devices supplied sterile are treated separately from class A non-sterile because sterility itself requires assessment.

The practical consequence is that the class determines not only the conformity assessment route but the date by which a legacy device must have left the old regime. That is why classification work, which looks like a documentation exercise, sets a firm’s entire compliance calendar.

The transition timetable, as extended

Regulation (EU) 2024/1860 extended the IVDR transitional periods for legacy devices. The Commission’s question-and-answer document sets out three gates per class: a deadline to lodge a formal application for conformity assessment, a deadline to sign a written agreement with a notified body, and the date the transitional period ends.

Both class D and class C gates have now passed. The next live deadline is 26 May 2027 for class B and class A sterile devices, with the written agreement due four months later. A manufacturer that has not applied by its class deadline loses the extension for that device, and the end date in the final column becomes irrelevant to it.

The conditions attached to the extension

The extension is conditional, and the conditions sit in Article 110(3c). The device must continue to comply with the rules that applied when it was first placed on the market. No significant changes to design or intended purpose may be implemented during the transitional period. A competent authority finding that the device presents an unacceptable risk to the health or safety of patients, users or other persons ends the transition for that device.

The one that caught firms out was the quality management system: a manufacturer had to have a quality management system under Article 10(8) IVDR in place no later than 26 May 2025, regardless of class, with its documentation forming part of the application. Full risk management and performance evaluation were not required by that date, but the system had to show how compliance would be reached.

Regulation 2024/1860 also added a supply obligation that is easy to overlook: manufacturers must inform the relevant competent authority and health institutions before supply of certain devices is interrupted or discontinued, and where they do not supply health institutions directly, must inform the economic operators in the supply chain, who inform the institutions in turn.

In-house tests and the health institution exemption

Article 5(5) lets a health institution manufacture and use its own devices without CE marking, and for hospital and public health laboratories this is the part of IVDR that bites. MDCG 2023-1 sets out what the exemption actually demands, and it is not a light touch.

The device may be manufactured and used only within a health institution established in the Union and may not be transferred to another legal entity. Manufacture and use must happen under an appropriate quality management system. The device must meet the relevant general safety and performance requirements in Annex I, with compliance documented. The institution must justify that the specific needs of its target patient group cannot be met, or cannot be met at the appropriate level of performance, by an equivalent CE-marked device — a justification to be formed before first manufacture, informed by a market review using sources such as EUDAMED, and reviewed regularly thereafter. It must publish a declaration of compliance, hold documentation on the facility, process, design and performance data for class D devices, and review clinical experience and take corrective action. The exemption does not cover manufacture on an industrial scale.

One point in the guidance deserves emphasis because it contradicts a common assumption. Accreditation to EN ISO 15189 does not by itself make a laboratory’s quality management system appropriate for manufacturing in-house diagnostics, because the standard does not address the manufacturing process or Annex I compliance. Laboratories already accredited therefore have work to do, not a shortcut. Article 10(8) is offered as a guide to designing what is missing.

“Health institution” is also narrower than it sounds. It means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health, which includes hospitals and also laboratories and public health institutes supporting the healthcare system; it excludes establishments primarily pursuing healthy lifestyles, such as gyms, spas and wellness centres. National legislation can affect recognition.

Where the competence burden falls

IVDR work splits awkwardly across functions. Classification and technical documentation sit with regulatory affairs; the quality management system sits with quality; the in-house justification and clinical experience review sit with the laboratory itself. The person responsible for regulatory compliance is a defined role with defined qualification requirements — see our guide to the PRRC role and its qualification routes, which follows the same pattern under the medical devices regulation. For laboratories managing personnel competence requirements alongside this, our guide to laboratory compliance and personnel requirements covers the parallel US framework.

Our CPD course library covers the quality management, risk and audit disciplines these roles draw on.

Frequently asked questions

Can a legacy device still be sold after its class deadline passed?

Only if the manufacturer met the application and written agreement gates for that class and continues to satisfy the Article 110(3c) conditions. The transitional end dates apply to devices that stayed inside the conditions; a device that missed its application deadline is not covered by them.

Does an in-house test need a notified body?

No. The Article 5(5) exemption removes the CE marking route, but it substitutes a set of obligations the institution must satisfy itself, including an appropriate quality management system, Annex I compliance, the no-equivalent-device justification and a published declaration of compliance.

Is ISO 15189 accreditation enough for in-house manufacture?

No. MDCG 2023-1 is explicit that compliance with EN ISO 15189 alone does not make a quality management system appropriate for in-house device manufacture, because the standard does not cover the manufacturing process or Annex I compliance.

Where should the dates be confirmed?

The Commission’s question-and-answer document carries a notice that it is non-endorsed, of a general nature and not legal advice, and directs readers to the Regulation text. For any decision with a deadline attached, read Article 110 as amended rather than a summary of it, including this one.