Introduction| This time, the EU is not “relaxing clinical requirements” butrewriting the logic of clinical evaluation
The 2025 MDR amendment draft (COM(2025)1023), if you only skim the summary, is easy to read as “streamlining” or “relaxation”:
Equivalence is more flexible
PSUR frequency is reduced
Certificates no longer have a fixed expiry date
Non-clinical data are more formally recognized
But if you really read the text from the perspective ofpractical regulatory submission / clinical implementationyou will find a more fundamental change:
The EU is not lowering clinical evaluation requirements; it is transforming clinical evaluation from a one-off pre-market compliance exercise into an evidence management system that spans the entire device lifecycle.
This article does not discuss macro policy or provide a regulatory translation; it answers only three questions:
In the draft,what exactly are all the new provisions / changes directly related to clinical evaluation?
What do these changesmean for manufacturers’ clinical evaluation and clinical lifecycle management?
From these changes,what future trends can we identify?
I. First, the conclusion: what is the core change the MDR draft makes to “clinical evaluation”?
If summarized in one sentence:
Clinical evaluation is shifting from “whether clinical work was done” to “whether the evidence forms a closed loop, can be continuously updated, and can withstand long-term scrutiny.”
This is not a slogan; it is reflected in a series of very specific, highly practical changes in the draft provisions.
Let’s break them down one by one below
II. Key changes in the draft directly related to clinical evaluation (must-read for regulatory and clinical teams)
1. Non-clinical evidence has been formally elevated:
Clinical evaluation ≠ clinical-investigation driven
What changed
The draft explicitly states:
it encourages the use of non-animal methods (NAMs)
and, where appropriate,it allows reliance solely on non-clinical data(bench, in vitro, ex vivo, in silico, etc.)to demonstrate conformity
The key is not whether clinical investigations were conducted, but whether:
you can justify why these non-clinical methods are sufficient to demonstrate safety and performance
and that justificationmust be included in the technical documentation (Annex II)for review by the Notified Body
At this point, Article 61(10) deserves real attention: one possible legislative intent behind the draft may be to give the Performance Route a clearer and more legitimate place.
What does this mean in practice for manufacturers?
This does not mean “clinical investigations will no longer be needed in the future”; rather:
the core capability required for clinical evaluation is changing
from “designing and executing clinical investigations” to
“building acoherent evidence chain from non-clinical evidence → clinical relevance → risk control → performance claimsthat is scientifically and regulatorily defensible”Clinical teams need a stronger understanding ofengineering / technology / performanceEvidence
Engineering/simulation teams need a deeper understanding of “what truly constitutes clinical relevance”
In the future, the challenge in CERs will lie not in the volume of data, but in the quality and logic of the justification.
2. The equivalence pathway is being “unlocked,” but it requires greater expertise
Key change
The draft makes it clear:
It removes the rigid requirement in the MDR to “sign a contract with the equivalent device manufacturer to obtain its technical documentation”
It allows, subject to certain conditions, the use ofclinical evaluations of third-party devicesto support its own conformity
But it also states very clearly:
The manufacturer must demonstrate:that the original clinical evaluation being relied upon is itself compliant with MDR requirements
Article 61(5)
What does this mean in practice for manufacturers?
This is a typical change that “appears more permissive, but in reality replaces one threshold with another”:
Previously, the main challenge was:“whether you could obtain the other party’s data”
Now the challenge has become:
Can you determine whether the other party’s CER is methodologically compliant with the MDR?
Can you usepublic information, registration data, and real-world use informationto build a verifiable equivalence justification?
The equivalence pathway is no longer a “legal contest,” but rather “evidence engineering.”
This creates opportunities for professional teams, but poses a challenge to “template-based CERs.”
3. PMCF is no longer a “standalone exercise,” but part of the continuous updating of the CER
Key change
The draft explicitly states:
The MDR revision draft does not explicitly state in the legal text that it will “eliminate the PMCF Evaluation Report,”
but through its legislative intent and the restructuring of Article 61,
the regulatory focus is no longer on “whether there is a standalone PMCF report,”
but on whether the evidence generated by PMCF is genuinely and systematically used to update the clinical evaluation.
It also emphasizes:
Clinical evaluation shouldthroughout the entire device lifecycle, be continuously updated based on PMCF and PMS data
（Article 61(11)
What does this mean in practice for manufacturers?
The CER is no longer a one-time pre-market deliverable
but rathera continuously updated “clinical evidence master file (living document)”
This effectively forces manufacturers to do three things:
) connect the data flows across clinical, vigilance, PMS, and medical affairs
) define which PMS/PMCF signals trigger CER updates
) turn CER updates into a “routine management activity,” rather than last-minute firefighting
Those writing CERs must begin paying attention to every post-market data point.
4. Class IIb / III devices: the clinical development strategy can “seek early alignment with experts”
Key change
For Class IIb and Class III devices, the draft adds a new mechanism:
Before clinical investigation or clinical evaluation, companies may
consult the expert panel on clinical development strategy or study protocol
Subsequent NB and CER assessments must “take that opinion fully into account”
（Article 61(2)
What does this mean in practice for companies?
This is a very “pharma-like” signal:
Clinical strategy is beginning to be viewed assomething that can be aligned with regulatory expectations in advance
The benefit is less rework
The risk is that once you take the consultation route, your decision logic is “on the record”
This is a tool for “high-maturity teams,” not a lifeline.
5. CECP（Clinical Evaluation Consultation Procedure) Narrower scope: regulatory resources are more concentrated on “truly high-risk” clinical evaluations
What changed
Clinical Evaluation Consultation Procedure (CECP)
will apply only to Class III implantable devices
Class IIb active drug-delivery/drug-removal devices are removed from the scope
（Article 54〕
What does this mean in practice for companies?
For some Class IIb devices, this is a clear reduction in burden
For Class III implants, it means:
higher quality requirements
more rigorous clinical justification
more focused and also more “selective” expert review
6. Certificates are no longer “renewed year by year,” but may be tied to PMCF conditions
What changed
Certificates will in principle no longer have a fixed expiration date
The NB may limit certificate validity for justified reasons
For example: requiring completion of specific PMCF
(Article 56 revised provision)
And it is spelled out more clearly in the breakthrough/orphan device pathway:
Certificates may be issued with limited pre-market clinical data, but post-market evidence and conditional certification must provide the backstop
(provisions related to breakthrough/orphan devices)
What does this mean in practice for companies?
This is a very important signal:
“Obtaining the certificate” is no longer the end point
Delivery of clinical evidence begins to affect the continuing validity of the certificate
For innovative devices, PMCF is elevated from a “compliance appendix” to a “critical variable for business continuity.”
A quick explainer on “orphan devices”: orphan devices are medical devices intended for very small patient populations with a clearly unmet clinical need. The regulatory focus is not that there is “little evidence,” but that, given the limited patient population, proportionate principles allow more targeted clinical evidence to be accepted, while uncertainty is controlled through continued post-market evidence generation,
So don’t interpret“orphan devices” as “devices for orphans” 🤭
III. From a clinical lifecycle management perspective: how will companies be forced to change?
Shift 1:
From “pre-market CER reporting” → “lifecycle evidence management”
CER, PMCF, PSUR, and SSCP are being integrated into a single evidence system,(This signal from the regulation is highly consistent with Clinsota’s long-standing advocacy for clinical lifecycle management.)
Updates will no longer rely on fixed intervals, but instead onSignal- and outcome-driven triggers
Shift Two:
From “whether there is a clinical trial” → “whether the evidence chain is complete and traceable”
Non-clinical data, simulation, and real-world data are being systematically incorporated
but the requirements for methodology, bias control, and clinical relevance are becoming more stringent
Shift Three:
From “renewal milestone-driven” → “continuous oversight + conditional management”
Non-fixed certificate validity ≠ lower risk
Instead, it means that clinical evidence must be ready at any time and clearly articulated
IV. Practical recommendations for regulatory/clinical teams (highly actionable)
Manage the CER as a living document
Clearly define input sources, trigger conditions, and update ownersDevelop in advance argumentation templates linking “non-clinical → clinical relevance”
especially for in silico / NAMs pathwaysReassess the equivalence strategy
Make “whether the original CER is MDR-compliant” a core focus of due diligenceDesign PMCF as a deliverable commitment
especially for innovative or potentially breakthrough devicesEnsure clinical evaluation is truly integrated into the post-market management system
rather than appearing only temporarily at the regulatory submission stage
Conclusion｜This is not the “end point” of clinical evaluation, but the point at which it truly begins to become a professional discipline
The clearest signal released by this MDR draft is:
Clinical evaluation is no longer about “writing a report”; it is a capability that must be continuously maintained.
Final note:
For regulatory and clinical teams, this is both a source of pressure and an opportunity to reassess their value.
