Item 2: Device Description, Intended Purpose/Indications, Claims

Deficiency

Evidence of compliance to Annex XIV 1 (a) sub-bullets 2, 3, 4 and 6, and Article 2 (53) is incomplete.

Requirements and references

• Annex II
• Annex XIV 1(a), sub-bullets 2, 3, 4, and 6
• Article 2(53)

MDF reference

MDF4550 §1.1.3, 3.1.2

Documents reviewed by BSI

• Device Description
• Intended Purpose/Indications
• Claims

Context

Note: the Clinical Evaluation and the Clinical Evaluation Report should be considered standalone, and may be used in future reviews without supporting documents, therefore, there is a necessity for clear description of the following components within the CER (and alignment in other documents where applicable):

Requirements

• Annex II describes the requirements for the following to be presented in a clear and unambiguous manner:
  • 1.1
    • product or trade name and a general description of the device including its intended purpose and intended users;
    • the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;
    • principles of operation of the device and its mode of action, scientifically demonstrated if necessary;
• Annex XIV 1 (a), sub-bullets 2 and 3 describe the requirements for a specification of the intended purpose and clear indications within the CEP
• Annex XIV 1 (a) sub-bullets 4 and 6 (and Article 2 (53)) specify the requirement for specific, relevant, and measurable clinical benefits and safety and performance outcomes (and acceptance criteria as based on SotA) to be established as part of the clinical evaluation plan, against which assessment should be performed in the clinical evaluation with supporting clinical data on the subject device

Observations for this item are split across the two requests below, as BSI structured them in direct correspondence with each request.