CEP, CER, CIP, CIR — what is it and what do I need it for?

The abbreviations CEP, CER, CIP, CIR and JCA refer to central documents and procedures in medical device law that manufacturers must prepare and carry out as part of clinical evaluation and clinical trials.

Let's go through them all one by one:

Clinical Evaluation Plan (CEP) — clinical evaluation plan

According to MDR Annex XIV Part A, the Clinical Evaluation Plan (CEP) is a planning document that determines the scope, methods and criteria for the clinical evaluation of a medical device. The CEP must include at least the following content:

• Determination of basic safety and performance requirements (GSPR) in accordance with Annex I MDR, which must be supported by relevant clinical data
• Specification of the intended purpose of the product
• Exact specification of the intended target groups with clear indications and contraindications
• Detailed description of the intended clinical benefits for patients with relevant specific parameters for the clinical outcome
• Specification of methods to be used to review the qualitative and quantitative aspects of clinical safety
• Clinical development plan with milestones

The CEP defines the procedure for preparing the clinical evaluation report and documents the strategy with which manufacturers demonstrate the safety and performance of their medical device. When this is done, the next work step can be started — provided that data has already been found that matches it.

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Clinical Evaluation Report (CER) — clinical evaluation report

In accordance with Article 61 MDR, the clinical evaluation report (CER) documents the results of the clinical evaluation and must be part of the technical documentation. In accordance with Article 2 paragraph 44 MDR, clinical evaluation is a systematic and planned process for the continuous generation, collection, analysis and evaluation of clinical data on a device to verify the safety and performance, including clinical benefits, when the device is used as intended.

In accordance with MDR Annex XIV Part A and MDCG Guideline 2020-13, the CER must include the following elements:

• Evaluation of all relevant clinical data through systematic literature review
• Evaluation of the suitability of the data to demonstrate the safety and performance of the product
• Assessment of the benefit-risk balance
• Objective conclusion as to whether the product complies with the relevant essential safety and performance requirements (GSPR) from Annex I MDR and is suitable for its intended purpose

The CER must be created for all medical devices regardless of the risk class and must be updated on the basis of new clinical data throughout the life cycle of the device, i.e. it is a document traditionally known as a “living document”.

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If the current data is insufficient, an equivalence study does not exist or is not accepted by a notified body or authority, or evidence is required for reimbursement, the next step is started to design a clinical trial:

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Clinical Investigation Plan (CIP) — Clinical Investigation Plan

In accordance with MDR Annex XV Chapter II Section 3 and ISO 14155:2020 Appendix A, the Clinical Investigation Plan (CIP) is a separate document that describes all aspects of a clinical trial in detail. The CIP includes the rationale, objectives, design, methodology, monitoring, implementation, recording, and method of analysis for a clinical trial. This also applies mutatis mutandis to clinical studies that are not classified as clinical trials (e.g. in accordance with Art. 62 MD). The better such a clinical trial has been prepared, the more economical, targeted and scientifically valuable it will be.

In accordance with ISO 14155:2020 Annex A and MDR Annex XV, the CIP includes at least the following conclusive information:

• General information about the clinical trial (title, reference number, sponsor, investigators, testing centers)
• Synopsis of the clinical trial with objectives, endpoints, appropriate measurement tools, inclusion and exclusion criteria, study design and number of participants
• Justification of study design based on clinical evaluation conclusions
• Description of the test device and its intended purpose
• Risk assessment and risk mitigation measures
• Statistical hypotheses and sample size calculations, statistical analysis plan
• Monitoring Plan

The CIP is the central document of a clinical trial and serves all parties involved as a basis for the design, planning, implementation and evaluation of the clinical trial. The culmination of a successful study is the final report, which is based on the objectives for the clinical trial:

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Clinical Investigation Report (CIR) — clinical trial report

The clinical investigation report (CIR) documents the results of a clinical trial in accordance with Article 77 MDR and ISO 14155:2020 Appendix D and must be prepared regardless of the outcome of the trial. In accordance with Article 77 MDR, the sponsor must submit a report and a summary of the CIR via the electronic system in accordance with Article 73 MDR within one year of the completion of a clinical trial or within three months of early termination of the CIR.

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In accordance with MDR Annex XV Chapter III Section 7 and ISO 14155:2020 Annex D, the CIR comprises at least the following content:

• Title, purpose and description of the audit
• Study design and applied methods
• Demographics of exam takers
• Results of the audit with regard to the defined endpoints
• Analysis of specific subgroups
• Overview of serious adverse events, product adverse effects and product deficiencies
• Discussion and overall conclusions on safety and performance outcomes, assessment of risks and clinical benefits

The summary of the CIR is structured and made publicly available in accordance with European Commission Guideline 2023/C 163/06.

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Joint Clinical Assessment (JCA) — Joint clinical evaluation

According to Regulation (EU) 2021/2282 on the Assessment of Health Technologies (HTA Regulation), the Joint Clinical Assessment (JCA) is a mandatory joint clinical evaluation of selected medical devices and in vitro diagnostics at EU level. The JCA evaluates the relative clinical effectiveness of a health technology compared to alternative treatments through a scientific analysis of clinical evidence on health outcomes.

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Implementing Regulation (EU) 2025/2086 of 17 October 2025 lays down the procedural rules, time limits, dossier formats and templates for joint clinical evaluations of class IIb and class D in vitro diagnostic devices. The JCA is mandatory for the following products:

• From January 12, 2028: Selected high-risk medical devices and IVDs in accordance with Article 21 paragraph 2 of the HTA Regulation

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As part of the conformity assessment process, manufacturers must submit specific clinical sections of their documentation to the notified body, which are then assessed by the HTA coordination group and expert bodies. The economic evaluation and final decision on reimbursement remain with the Member States, which must “take due account” of the JCA outcome.

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MEDIACC provides support in the clinical evaluation of medical devices, from planning to implementation. This includes systematic literature research and evaluation to prepare a well-founded clinical evaluation plan (CEP) to documentation of the clinical trial in the clinical trial report (CIR). It is important that it is not just a matter of creating any document, but preferably about the medical device, the aim and purpose of the manufacturer, the optimal implementation strategy and operationalization known from many years of experience, in order to ultimately quickly and permanently convince the highly regulated market.

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Do you need an assessment or initial advice on the classification of your medical device or are you wondering whether you need a clinical trial or clinical trial? Contact us for an initial consultation!

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