Clinics under the MDR: how to navigate between clinical evaluation, clinical investigation and applicable standards?

Medical devices regulation

26 November 2025

The clinical section is one of the most misunderstood areas of the MDR. Not because of a lack of technical competence, but because the texts pile up concepts, related terms and reference documents, without always spelling out how they fit together.

This often results in clinical strategies being developed too late, investigations being launched by reflex, or, conversely, technical files being weakened by insufficient clinical demonstration.

Clarifying these concepts, understanding their respective roles and knowing which texts are the real structuring factors is now essential for securing a medical device project.

Clinical evaluation, clinical investigation, clinical trial, clinical study: what are we really talking about?

Confusion often starts with the vocabulary.

Clinical evaluation

Systematic, documented process designed to collect, analyze and evaluate all clinical data relating to a device, in order to demonstrate its safety, performance and clinical benefits in relation to its intended use and purpose.

This is a mandatory regulatory requirement for all devices placed on the market (MDR, article 61).

Clinical investigation

A study carried out on human subjects to generate clinical data specific to the device.

It is used when existing data are insufficient to demonstrate clinical conformity.

Clinical trial / clinical study

In medical devices, these terms are considered synonymous with clinical investigation, particularly as defined by ISO 14155. Their use is more historical or Anglo-Saxon than regulatory.

Key point:

Clinical evaluation is a continuous, structuring process.

Clinical investigation is a possible, but not systematic, means of feeding this process.

	Definition (regulatory meaning)	Main objective	Involves human subjects	Regulatory / normative framework	Key deliverables	Timing
Clinical evaluation	Systematic and documented process intended to collect, analyse, and assess all clinical data in order to demonstrate the safety, performance, and clinical benefits of the device in relation to its intended use and purpose	Demonstrate clinical conformity and the benefit-risk ratio	No	MDR Art. 61, Annex XIV; MDCG 2020-6; draft ISO 18969	Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER)	Continuous, throughout the entire life cycle
Clinical investigation	Systematic study conducted on one or more human subjects to assess the safety, performance, or clinical effectiveness of a device	Generate device-specific clinical data when existing data are insufficient	Yes	MDR Arts. 62-82; ISO 14155	CIP, IB, investigation reports, raw clinical data	One-off, time-limited
Clinical trial	Generic term commonly used to refer to a clinical investigation in the context of medical devices	Same as clinical investigation	Yes	ISO 14155 (accepted synonym)	Same as for a clinical investigation	One-off
Clinical study	Generic term that may cover a clinical investigation or an observational study; in medical devices, commonly used as a synonym for clinical investigation	Variable depending on context	Most often yes	ISO 14155 (usage equivalent to clinical investigation)	Depending on the type of study	One-off or observational

Points of attention for manufacturers

Clinical evaluation is mandatory for all medical devices, with or without clinical investigation.
A clinical investigation is not systematic, but results from a prior analysis of the sufficiency of clinical evidence.
The terms clinical trial and clinical study have no independent regulatory value in DM, and in practice refer to ISO 14155.
Confusing these notions often leads to over-designed clinical strategies or, conversely, to insufficiently defensible CERs.

Clinical evaluation: the backbone of clinical demonstration

Under the MDR, clinical evaluation is no longer an isolated documentary exercise. It forms the backbone of the clinical demonstration of the device throughout its life cycle.

It aims to answer a simple but demanding question:

is there sufficient clinical evidence to demonstrate that the clinical benefits of the device outweigh the residual risks, in terms of the state of the art?

In concrete terms, clinical evaluation is based on:

data from the scientific literature,
clinical data generated by investigations,
post-market data, including PMCF,
a rigorous analysis of the state of the art and therapeutic alternatives.

The structuring MDCG guides on this point include:

MDCG 2020-6 on the sufficiency of clinical evidence,
MDCG 2020-13 and its CER templates.

The Clinical Evaluation Report (CER) is a central document in the technical file, directly scrutinized by notified bodies.

ISO 18969 (draft): towards enhanced standardization of clinical evaluation

The draft standard ISO 18969 - Clinical evaluation of medical devices, developed by ISO/TC 194, is part of a clear context: heterogeneous practices, varying expectations from notified bodies, and the need for more robust methodologies.

Although it is still a draft, a number of key directions are emerging:

greater formalization of the clinical evaluation process,
tighter requirements on state-of-the-art analysis and clinical benchmarks,
clarification of the link between clinical evaluation, risk management (ISO 14971) and PMS/PMCF,
emphasis on the competence of the players involved.

This future standard is clearly intended as a methodological reference.

Manufacturers who are already anticipating these expectations are strengthening the solidity of their dossiers and reducing the number of iterations with notified bodies.

When and why a clinical investigation becomes necessary

One of the most common errors is to consider clinical investigation as an obligatory step.

In reality, the decision to launch an investigation should be the result of a structured clinical evaluation.

An investigation is generally necessary when :

the device is innovative or presents new clinical characteristics,
literature data are insufficient or non-transposable,
clinical equivalence cannot be robustly demonstrated,
residual risks or clinical claims require specific data.

Conversely, some devices can demonstrate clinical compliance without pre-market investigation, subject to robust justification, supported by:

clinical equivalence (MDCG 2020-5),
relevant post-market data,
a suitable PMCF strategy (MDCG 2020-7 and 2020-8).

ISO 14155: the reference framework for clinical investigations

Whenever a clinical investigation is required, ISO 14155 becomes essential.

It defines the principles of good clinical practice applicable to medical devices:

protection of participants,
scientific rigor,
data traceability,
sponsor responsibilities.

In particular, it structures :

the Clinical Investigation Plan (CIP),
the Investigator's Brochure (IB),
management of adverse events,
the clinical investigation report.

ISO 14155 is closely linked to risk management. The data generated must feed into risk management, clinical evaluation and, ultimately, the technical file.

A rational overview of clinical MDCG guides: which ones are really essential?

Faced with the profusion of MDCG documents, prioritized reading is essential.

Base MDCG guides, useful for all manufacturers

MDCG 2019-9 (SSCP)
MDCG 2020-6 (sufficient clinical evidence)
MDCG 2020-13 (CER templates)
ISO 14155

MDCG guides to be activated according to clinical strategy

MDCG 2020-5 (equivalence)
MDCG 2023-7 (investigation exemptions)
MDCG 2024-10 (orphan medical devices)

Operational MDCG guides for investigations

MDCG 2021-8 (submission dossiers)
MDCG 2024-3 (CIP)
MDCG 2024-5 (IB)
MDCG 2020-10-1 and 10-2 (safety reporting)

MDCG post-market and vigilance guides

MDCG 2025-10 (PMS)
MDCG 2022-21 (PSUR)
MDCG 2024-1 and associated DSVG

Case studies

Case 1: Incremental DM IIa

Device with proven technology and intended use close to the state of the art.

Clinical strategy based on:

robust literature,
demonstrated clinical equivalence,
Targeted PMCF.

No pre-market investigation required, subject to solid CER.

Case 2: Innovative DM III

New technology with strong clinical claims.

Clinical evaluation showing insufficient existing data.

Clinical investigation essential, structured according to ISO 14155, with early integration into R&D and regulatory strategy.

Mini FAQ

Can a clinical evaluation exist without a clinical investigation?

Yes, if existing data are sufficient and properly justified.

When should I start clinical evaluation?

At the earliest stages of development, not when CE marking is approaching.

Can PMCF replace a pre-market investigation?

In certain cases, yes, but only if the risk and level of innovation allow it.

Is clinical equivalence still realistic under the MDR?

Yes, but it is strictly regulated and requires robust demonstration.

Should we anticipate ISO 18969 now?

Yes, as a methodological reference, even before its official publication.

Conclusion

The MDR clinic structures the entire project, from R&D to post-market surveillance, in close conjunction with risk management and regulatory strategy.

In this context, CSDmed supports its customers - start-ups, manufacturers, importers and distributors of medical devices - with in-depth regulatory expertise and a methodical approach to clinical demonstration. This approach enables the coherent articulation of clinical evaluation, risk management, clinical investigation strategy, PMCF and MDR / IVDR technical file requirements, taking into account the level of innovation, the risk class and the real expectations of notified bodies.

Contact us to structure and secure your clinical strategy, from the early stages of your project and throughout the device's life cycle.