MEDDEV 2.7.1 /Rev.4

Clinical Evaluation: A guide for manufacturers and notified bodies

임상평가의 동등성에 대해 안내드립니다.

먼저 임상평가를 위해 필요한 개념인 clinical data, evaluation evidence에 대해 확인하면,

임상 평가에 대한 가이드라인에는 다음과 같이 용어의 정의가 설명되어 있습니다.

• Clinical data : the safety and/or performance information that is generated from the clinical use of a device. Clinical data are sourced from:
  • clinical investigation(s) of the device concerned; or
  • clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
  • published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

• Clinical evaluation : a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.

• Clinical evidence : the clinical data and the clinical evaluation report pertaining to a medical device.

MDR 에서도 또한 설명하고 있습니다.

• Clinical evidence : clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

• Clinical Evaluation : 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;

• Clinical Data : information concerning safety or performance that is generated from the use of a device and is sourced from the following:
  • clinical investigation(s) of the device concerned,
  • clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
  • reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
  • clinically relevant

각 기기는 임상적, 기술적, 생물학적 특성에 대해 동등성이 평가되어야 합니다.

MDR에서 아래와 같이 확인할 수 있습니다.

A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:

• Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
• Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
• Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.

The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. Considerations of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.