Authored by Jennifer Russell, Senior Scientific Project Manager
December 19, 2025
On December 16th, 2025, the eagerly anticipated European Commission's proposal to simplify rules on medical and in vitro diagnostic devices was released.
The 170 pages of proposed changes do achieve, at least in part, what the Regulators set out to do. Simplifying requirements, allowing demonstrated equivalence, adding Breakthrough/Orphan Device pathways, combining CTA submissions and expanding the remit of the Health Institution Exemption to include Clinical Research, are all steps in the right direction.
Though I do fear the proposal has been a victim of the dreaded 'IVDR Scope Creep'. Experience tells me that the addition of 4 words, could have lasting repercussions and somewhat nullify the EC's aim to 'put in place a proportionate, efficient and flexible framework, increase legal certainty, support more coherent implementation across the Union and sustain the high level of health protection set out in the MDR and IVDR', at least from a Clinical Research Perspective.
IVDR Certification / Continued IVD Access
- 'A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation'
- 'The requirements for a notified body certificate for relabelling and repackaging activities, as well as the prior notice obligation, are removed.'
- 'The involvement of notified bodies in the conformity assessment of lower and medium risk devices (class IIa and IIb and class B and C) will be reduced'
- 'The coordination among competent authorities regarding the qualification of a product and the classification of a device (‘Helsinki procedure’) will be codified, with the possibility to request opinions from expert panels'
- Notification of removal of an IVD from the EU market 'shall be provided at least six months before the anticipated interruption or discontinuation'
The proposed measures for a more proportionate approach to IVDR certification and continued IVD access will be a relief for both IVD Manufacturers and Pharmaceutical Sponsors. For the first time in almost a decade, Clinical Development would be able to move forward with confidence when relying on IVDs to support therapeutic claims and meet the specific needs of target patient populations.
Breakthrough / Orphan Devices
- 'After ‘designation’ by an expert panel, breakthrough devices and orphan devices will be subject to a priority and rolling review. Manufacturers have access to expert panels’ advice.'
- 'Orphan devices that were CE marked under the former Directives and for which an expert panel has confirmed that they meet the criteria of ‘orphan device’ may continue to be placed on the market beyond the transitional periods'
- A device shall be considered a breakthrough device is if meets the following criteria:
- it is expected to introduce in the Union a high degree of novelty with respect to the device technology, related clinical procedure or the application of the device in clinical practice;
- it is expected to provide a significant positive clinical impact on patient or public health, for a life-threatening or irreversibly debilitating disease or condition, by either of the following: (i) offering a significant positive clinical or health impact compared to available alternatives and the state of the art; (ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.
- A device shall be considered an orphan device if it meets the following criteria:
- the device is intended to provide information on a disease or condition that presents in not more than 12 000 individuals in the Union per year;
- at least one of the following criteria is met: (i) there are insufficient available alternatives; (ii) the device is expected to provide a clinical benefit compared to available alternatives or the state of the art.
The addition of these definitions, expert panel collaboration and true risk/benefit-based approval pathways, truly is great news for those working in or suffering from Rare Diseases. The proposals, if implemented effectively, would indeed reduce the regulatory burden and increase EU patient access to novel therapeutics.
Companion Diagnostics (CDx)
- 'Performance studies involving only routine blood draws will not be subject to prior authorisation.'
- 'The notification of performance studies on companion diagnostics using left-over specimens will be removed'
- 'For combined studies, the sponsor may submit a single application, triggering a coordinated assessment'
The move to a combined, coordinated assessment is great news for precision medicine! The proposal would align the EU with the aims of the ongoing FDA and UK MHRA reviews, allowing for more proportionate, patient focused, CDx regulation.
Clinical Research - Health Institution Exemption
- Central laboratories manufacturing and using tests exclusively for clinical trials are added to the scope of the in-house device exemption'
- 'Documentation that the target patient group's specific needs cannot be met by an equivalent device on the market has been removed.'
- 'Devices are not transferred to another legal entity, except to another health institution in the duly justified interest of public health, patient safety or patient health'
- The Health Institution exemption shall apply to 'a laboratory that is established in the Union and provides consistent, state of the art testing services for clinical research'
At a time with so much focus and awareness on protocol wording when navigating the IVDR, it is somewhat ironic that with only 4 words, the European Commissions highly commendable efforts in removing the major barriers to clinical research has essentially been undone.
Clinical research is Global. Technology advancements are Global. Streamlining testing within one laboratory is key to gathering reliable, comparable data, particularly in early phases of clinical development.
The EC have (perhaps inadvertently), ruled out the ability for Clinical Trial Sponsors to conduct Global Centralized Testing for EU participant management, within non-EU based laboratories, regardless of their compliance to all other aspects of the exemption. Through my work as an industry Consultant, I'm acutely aware that clinical research relies on a highly skilled network of Global Laboratories, many of whom are not established in the Union. We can only hope that this was, as is often the case with protocol writing, an inadvertent scope creep in applying the IVDR.
To achieve the ambitions of removing 'unnecessary administrative burden on health institutions, to promote clinical research on in-house devices and to enable the access of patients to in-house devices where no alternatives exist', I would urge the Regulators to make one minor edit to the proposal;
The Health Institution Exemption 'shall also apply to devices manufactured and used within a laboratory that provides consistent, state of the art testing services for clinical research, provided those devices are intended exclusively for use in the framework of a clinical trial subject to Regulation (EU) No 536/2014'.
The proposal states adoption of the Regulation is expected by Q2 2027, with the first step to complete the Trialogue process for agreement between the European Commission, Parliament and Member states. So this is very much a first draft proposal, with many discussions, position papers and requested edits to look forward to in 2026!
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