Clinical evaluation of medical devices

The clinical evaluation is not a document but a process covering the entire product life cycle. Manufacturers use it to review the safety, performance, and effectiveness of their devices. This process produces documents such as

• the Clinical Evaluation Plan and
• the Clinical Evaluation Report.

1. Clinical evaluation: the basics

a) Definition and objectives of the clinical evaluation

The MDR defines the term as follows:

“‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;”

MDR Article 2, Sentence 44

The MDR thus also determines the objective: to review the safety, performance, and clinical benefit. Clinical evaluation is, therefore, a prerequisite for placing medical devices on the market.

The clinical evaluation must be based on clinical data to obtain the necessary clinical evidence.

b) Clinical evaluation in the product life cycle

The activities involved in clinical evaluation are closely interlinked with other activities in the product life cycle, such as development (see Fig. 1).

c) Advantages of a professional clinical evaluation

Manufacturers benefit from a professional and legally compliant clinical evaluation:

• Avoid the hassle with reviews, audits, and approvals
  The clinical evaluation file is the focus of almost all auditors and reviewers. Deviations are the rule rather than the exception, but they can be avoided.
• Minimize development risks
  During clinical evaluation, the manufacturer must research the state of the art at the beginning of development, including the competition and the performance of the devices. This impacts whether clinical investigations are necessary, which often delay the development project by years. Development projects regularly fail because these factors parameters are considered too late.
• Bringing devices to market faster
  Rapid development and smooth approval lead to rapid placing in the market and, thus, to early sales.
• Improve patient safety
  By definition, clinical evaluation examines the quality of devices, i.e., their safety, performance, and clinical benefit.
• Avoid damage to the image and costs for recalls
  High-quality devices are suitable for the company’s image and reduce the costs of product recalls.
• Targeting marketing communication
  The clinical evaluation ensures that the intended purpose and intended use are precisely formulated. This forms the basis and framework for coherent and legally compliant marketing communication.

2. Regulatory requirements for clinical evaluation

a) MEDDEV 2.7/1 revision 4

The Medical Device Directive MDD already required a clinical evaluation, albeit somewhat vaguely. This is why MEDDEV Guideline 2.7/1 (revision 4 since 2016) exists, which provides more detailed clinical evaluation instructions.

Although the guideline is not legally binding, it has been the gold standard and reference for the content and structure of clinical evaluations. Auditors still require compliance.

The MDCG guidelines also refer to MEDDEV 2.7/1 Rev. 4, which, therefore, loses none of its relevance.

b) MDR

The MDR dedicates Article 61 and Annex XIV (Part A) to clinical evaluation. Both make many of the requirements of MEDDEV 2.7.1, Rev. 4, legally binding.

c) MDCG guidelines

In addition, the Medical Device Coordination Group (MDCG) has published several guidelines on clinical evaluation. Table 1 provides an overview.

d) Summary

Regulation/Guideline	Type / Relevance / How does it help you?	Prio
MDR (2017/745)	Defines the regulatory requirements that all manufacturers must fulfill. It gives initial instructions on how to carry out the clinical evaluation.	1
MEDDEV 2.7/1 rev. 4	Provides concrete instructions, like a “cookbook,” on how to structure and carry out the clinical evaluation process.	2-3
MDCG 2020-1	Provides a detailed interpretation of the MDR regarding the clinical evaluation of software as a medical device.	2
MDCG 2020-5	Provides a detailed interpretation of the MDR regarding clinical evaluation based on equivalence to other devices.	2
MDCG 2020-6	Gives a detailed interpretation of the MDR regarding the clinical evaluation of existing products.	2
MDCG 2020-13	Is the “checklist” (the CEAR template) that auditors use to assess the clinical evaluation. (CEAR = Clinical Evaluation Assessment Report)	2
IMDRF MDCE WG/N56	A “quick guide” with specific instructions, shorter than the MEDDEV and not a gold standard, but with helpful tips on literature assessment.	4

Tab. 1: The relevant regulations and guidelines for clinical evaluation

4. Further articles

a) Articles on individual activities

The following articles provide assistance with the activities listed:

• Formulate intended purpose and intended use
• Write a clinical evaluation plan
• Determine end points
• Determine the state of the art
• Research and evaluate literature
• Collect clinical data
• Create clinical evaluation report for software
• Conduct post-market surveillance

b) Articles on clinical investigations

Manufacturers must conduct a clinical investigation if they do not have sufficient clinical data.

• Clinical evaluation of medical devices under the MDR
• Case number planning in clinical investigations for medical devices and IVDs
• Clinical endpoints
• Insurance for clinical investigations

c) Articles on regulatory documents and other topics

• MDCG 2020-5: The end of the equivalence route in clinical evaluation?
• MDCG 2020-6: Requirements for clinical data for legacy devices
• Selecting Health Technology Assessment (HTA) for software