ISO 14155 医療機器の臨床試験計画の任意評価 (英語)

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Voluntary assessment of clinical investigation plans for medical devices in accordance with ISO 14155

Prior to regulatory approval in the European Union (EU) and other jurisdictions, manufacturers of certain medical devices must conduct a clinical investigation to thoroughly assess the safety and/or clinical performance of their products. Clinical investigations are designed to collect data and information not readily available in scientific literature or from prior pre-clinical testing that can be used as evidence to substantiate a manufacturer’s claims of the safety and/or performance of a given device. Data collected through a clinical investigation can be an essential element of the clinical evaluation report prepared in connection with an application for conformity assessment of the device.

Clinical investigation plans for medical devices

The proper design of a clinical investigation plan is essential for medical device manufacturers, since poorly designed plans can result in data that fail to sufficiently support a manufacturer’s safety and/or performance claims. In some case, a clinical investigation plan fails to identify rules and procedures for the collection of data. In other instances, the sample size identified in the plan is not based on scientific and statistical principles but solely on a manufacturer’s experience. In other cases, the investigation plan fails to select a study protocol that minimises sample bias. These and other flaws in the design of a clinical investigation plan can impede the regulatory approval process and delay market access.

At a minimum, a clinical investigation must follow a proper risk management process to identify all possible risks associated with a medical device, and be appropriately designed to collect clinical data relevant to the safety and performance of the device. ISO 14155, Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice, provides detailed information regarding clinical investigation principles, the process of conducting a clinical investigation, and the information to be collected. A clinical investigation plan designed to comply with the requirements of this standard helps to ensure the collection of objective and credible scientific data, and supports the overall goal of protecting the safety and well-being of patients.  

Why choose TÜV SÜD

TÜV SÜD Product Service experts can conduct a voluntary pre-assessment of a medical device manufacturer’s clinical investigation plan in advance of execution. In addition, TÜV SÜD Product Service has a global staff of medical device specialists, with over 400 international experts located in major markets around the world. These specialists are supported by the in-house Clinical Centre of Excellence and the scientific advisory board that is under the standard TÜV SÜD confidentiality agreement. This board comprise well-recognised European scientists and physicians from the leading universities and healthcare centres.

Our services at a glance

  • Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
  • Design dossier review and certification - As an EU Notified Body, TÜV SÜD Product Service can review design dossiers for medical devices and issue design examination certificates in accordance with the EU’s directives for medical devices.
  • Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
  • GLP-compliant biocompatibility evaluations - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
  • Authorised “Accredited Persons” under FDA Part 820 regulations - TÜV SÜD Product Service conducts inspections under the Accredited Persons (AP) Program of the US FDA according to 21 CFR 820.
  • Other testing and certification services - TÜV SÜD Product Service can conduct compliance testing for medical devices in accordance with other relevant regulations and standards.
  • Training - TÜV SÜD Academy offers seminars, webinars and general training courses addressing literature search for clinical evaluation, clinical investigation plan, clinical evaluation report according to MEDDEV 2.7.1 rev. 3 as well as training for other technical and regulatory requirements applicable to medical devices.

Your benefits at a glance

  • Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
  • Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
  • Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
  • Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
  • Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.


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