Clinical Development Plan for Medical Devices under MDR

A Clinical Development Plan, or CDP, defines how a medical device manufacturer will generate the clinical evidence required throughout the device lifecycle.

Under Part A of Annex XIV to Regulation (EU) 2017/745, the CDP forms part of the Clinical Evaluation Plan. It should show the planned progression from exploratory investigations to confirmatory investigations and post-market clinical follow-up, including milestones and potential acceptance criteria.

The CDP should connect each material evidence gap with a planned activity, decision point and expected outcome. It should not assume that every device requires the same sequence of studies.

What is a Clinical Development Plan under the MDR?

The Clinical Development Plan is the evidence-generation component of the Clinical Evaluation Plan.

It explains:

• what clinical evidence is already available;
• which claims, risks or uncertainties require further evidence;
• which pre-market and post-market activities will generate that evidence;
• how the programme will progress from exploratory to confirmatory work;
• what milestones must be reached before the next development decision;
• which acceptance criteria will be used to evaluate the results;
• how post-market clinical follow-up will address residual uncertainties.

The MDR does not prescribe one universal CDP format. Its depth should reflect the device, intended purpose, risk classification, novelty, claims, available evidence and lifecycle stage.

CDP vs CEP, CIP, CER and PMCF Plan

Document	Primary purpose	Main output
Clinical Development Plan	Defines how clinical evidence will be generated over time.	Evidence-generation activities, milestones, acceptance criteria and decision points.
Clinical Evaluation Plan	Defines how all relevant clinical data will be identified, appraised and analysed.	Scope, methods, evidence requirements, acceptance criteria and update strategy.
Clinical Investigation Plan	Defines how one clinical investigation will be designed and conducted.	Objectives, design, population, endpoints, methodology, monitoring and analysis.
Clinical Evaluation Report	Documents the evidence identified and the conclusions of the clinical evaluation.	Appraisal, analysis, benefit-risk conclusions, evidence gaps and conformity assessment.
PMCF Plan	Defines how post-market clinical data will be collected proactively.	PMCF methods, objectives, endpoints, schedule and reporting arrangements.

The CDP forms part of the Clinical Evaluation Plan but may be maintained as a separate controlled document when the development programme is complex.

When is a Clinical Development Plan required?

Annex XIV requires the Clinical Evaluation Plan to include a Clinical Development Plan. This applies to the clinical-evaluation process for medical devices under the MDR.

The content will vary according to the device’s maturity:

• New devices: map the progression from early feasibility work to confirmatory investigations and post-market evidence generation.
• Modified devices: identify whether the change affects intended purpose, claims, risks, clinical performance or the applicability of existing evidence.
• Legacy devices: document the available evidence, remaining gaps and proportionate PMS or PMCF activities required to maintain the clinical evaluation.
• Devices with new claims or indications: define the evidence needed before the new claim can be supported.
• CE-marked devices: connect residual uncertainties and emerging evidence needs with PMCF and future clinical-development activities.

A mature device may not require the same investigative sequence as a novel device, but the manufacturer should still document how existing evidence and future activities support continued conformity.

What should a Medical Device Clinical Development Plan include?

1. Scope and device definition

Identify the device, variants, accessories and configurations covered by the plan.

Define:

• intended purpose;
• indications and contraindications;
• intended patient population;
• intended users and use environment;
• device classification;
• clinical benefits and performance claims;
• relevant safety claims;
• lifecycle and regulatory stage;
• territories or regulatory pathways covered.

The scope should remain consistent with the Instructions for Use, labelling, risk-management documentation, CEP and CER.

2. Clinical context and state of the art

Summarise the clinical condition, current treatment options and accepted standards of care.

Identify the safety, performance and clinical-benefit parameters against which the device will be evaluated. These benchmarks should inform the evidence requirements and acceptance criteria defined later in the plan.

3. Existing evidence and gap assessment

List the relevant evidence already available from:

• non-clinical testing;
• previous clinical investigations;
• published literature;
• equivalent or similar devices;
• PMS and vigilance;
• PMCF activities;
• registries and real-world use;
• user feedback and complaints.

For each material claim or risk, state whether the available evidence is sufficient, partially sufficient or insufficient.

Do not treat every absence of data as an automatic requirement for a new clinical investigation. Explain why the gap matters and which evidence-generation method is proportionate to the question.

4. Planned evidence-generation pathway

Map the activities needed to address the identified gaps.

The programme may include:

• usability or human factors studies;
• exploratory or early feasibility investigations;
• first-in-human investigations;
• pilot studies;
• confirmatory or pivotal clinical investigations;
• observational studies;
• registries;
• literature or real-world evidence activities;
• PMCF studies;
• surveys or structured user feedback.

Each activity should address a defined clinical question. Avoid including an activity solely because it is conventional for another device type.

5. Milestones and decision points

Define when the programme will be reviewed and what decision each milestone supports.

Examples include:

Milestone	Decision supported
Completion of feasibility work	Whether the device and investigation procedures are ready for confirmatory evaluation.
Availability of preliminary safety data	Whether enrolment or expansion can continue under the defined risk controls.
Completion of a pivotal investigation	Whether the evidence supports the intended clinical claims and submission strategy.
Completion of initial PMCF activity	Whether residual uncertainties have been reduced or further evidence is required.
Introduction of a new indication or claim	Whether the existing evidence remains applicable or additional evidence generation is needed.

Milestones should be linked to owners, planned timing, evidence outputs and the documents that must be updated.

6. Acceptance criteria

Describe the prospective criteria used to determine whether an activity has achieved its objective.

Acceptance criteria may address:

• clinical performance;
• safety outcomes;
• clinical benefit;
• usability or procedure-related risks;
• comparison with the state of the art;
• residual uncertainty;
• completeness and quality of the evidence;
• feasibility of the next development stage.

The criteria must be specific to the device and supported by the clinical context. Do not invent a universal statistical threshold or require every evidence source to demonstrate statistical significance.

7. Pre-market and post-market integration

The CDP should connect the pre-market programme with PMS and PMCF.

For each remaining uncertainty at the time of submission, state:

• why it can be addressed after market access;
• which PMCF activity will address it;
• the expected evidence output;
• the milestone and acceptance criterion;
• how the findings will feed into the CER, risk-management file and other technical documentation.

PMCF should not appear as a generic final step. It should answer specific residual questions identified through the clinical evaluation.

8. Responsibilities and document interfaces

Identify who owns, reviews and approves each activity and development decision.

The CDP should remain aligned with:

• Clinical Evaluation Plan;
• Clinical Investigation Plans;
• Clinical Evaluation Report;
• risk-management file;
• PMS and PMCF plans;
• Instructions for Use and clinical claims;
• General Safety and Performance Requirements;
• technical and regulatory development plans.

Document the version, approval date, revision history and relationship with previous plans.

How to determine whether a new clinical investigation is needed

A new clinical investigation should follow from an identified evidence need, not from a generic assumption based only on device class.

Use this assessment:

Step 1: Define the clinical evidence required

Start with the intended purpose, clinical benefits, claims, risks, target population and state-of-the-art benchmarks.

Step 2: Assess the available evidence

Review device-specific data, literature, previous investigations, PMS, PMCF and any evidence proposed through equivalence.

Step 3: Determine whether the evidence is sufficient

Assess the relevance, quality, applicability and completeness of the evidence for each material claim and risk.

Step 4: Select a proportionate evidence-generation method

Decide whether the remaining question requires a clinical investigation, PMCF study, registry, observational evidence, usability work or another justified method.

MDR Article 61(10) is not a general low-risk-device exemption from clinical evaluation. When demonstration of conformity based on clinical data is not considered appropriate, the manufacturer must provide a justification based on the device’s interaction with the human body, intended clinical performance and claims.

For implantable and Class III devices, MDR Article 61 establishes more demanding clinical-investigation requirements, subject to the specific conditions and exceptions stated in the Regulation. Avoid describing a new clinical investigation as universally unavoidable without completing the device-specific assessment.

ISO 14155:2026 and the Clinical Development Plan

When the CDP includes a clinical investigation, the investigation should be planned and conducted against the current Good Clinical Practice framework.

ISO 14155:2026 is the current international edition for medical device clinical investigations. It replaced ISO 14155:2020 in March 2026.

The standard applies to the design, conduct, recording and reporting of clinical investigations. It does not define the complete MDR Clinical Development Plan, which remains part of the clinical-evaluation framework under Annex XIV.

When should the Clinical Development Plan be updated?

Review the CDP when new information changes the evidence strategy or the sequence of planned activities.

Potential triggers include:

• a change to the intended purpose, indication or patient population;
• a new or revised clinical claim;
• significant design or software changes;
• new hazards or changes to the benefit-risk assessment;
• results from an exploratory or confirmatory investigation;
• PMCF or PMS findings;
• new evidence affecting the state of the art;
• a failed milestone or unmet acceptance criterion;
• a change to the regulatory or market-access strategy;
• a decision to cancel, replace or add an evidence-generation activity.

The MDR does not establish a universal two-to-five-year update schedule for every Clinical Development Plan or every lower-risk CER. The update approach should be justified according to the device, risks, evidence generation and applicable MDR requirements.

Clinical Development Plan review checklist

Before approving the plan, confirm that:

• The device, variants, intended purpose and claims are clearly defined.
• The CDP is connected to the Clinical Evaluation Plan.
• Existing clinical evidence has been assessed.
• Material evidence gaps and uncertainties are explicit.
• Each planned activity addresses a defined gap or clinical question.
• Exploratory, confirmatory and PMCF activities are connected.
• Milestones and decision points are defined.
• Acceptance criteria are prospective and measurable.
• The need for a new clinical investigation has been justified.
• Responsibilities, timing and evidence outputs are assigned.
• Update triggers and version control are documented.
• The CDP aligns with the CEP, CER, risk-management file, PMS and PMCF plans.

Frequently asked questions

Support with medical device clinical development

MDx CRO supports manufacturers with clinical-development strategy, evidence-gap assessment, Clinical Evaluation Plans, clinical investigations and PMCF planning.

Discuss your Medical Device Clinical Development Plan with MDx CRO