Under the European Commission’s new In Vitro Diagnostic Regulation (IVDR 2017/746). In vitro diagnostic (IVD) medical devices manufacturers selling in Europe shall demonstrate the safety and the effectiveness of their devices by providing a compilation of documents, called Technical File, to a notify body (i.e. BSI).
The preparation of this documentation can be highly challenging, especially for small companies with limited resources (including Regulatory experts). It requires precision, detail-oriented skills and a multidisciplinary approach. Among the plethora of information to be compiled and verified to compose a CE Technical File according to the IVDR, 7 key elements shall not be missed:
1. The Device Description & Specification
In this section, the intended purpose of the device and its intended users shall be described. As well as, the principle of the assay, components, specimen collection, transport materials, instruments, software and accessories intended to be used with the device. The UDI-DI of the device, its risk class, its variants, and all previous/similar device generations shall be also referenced in this chapter.
2. The Information To Be Supplied By The Manufacturer
Here you shall specify the label(s) placed on the device and on the packaging (sales packaging, transport packaging, etc.), as well as the instruction for use (IFU). The IVDR mentions that these information shall be provided in the languages accepted in the Member States where the device is envisaged to be sold (24 official languages!).
3. The Design & Manufacturing Information
In this chapter, you shall specify a description of the critical ingredients, major subsystems (for instruments), and algorithms (for software), as well as an overview of the system (for instruments and software) pertaining to the device. Additionally, information to allow the entire manufacturing processes and identification of all production sites shall be also specified here (procedures, process flow diagram, manufacturing configuration, etc.).
4. The General Safety & Performance Requirements
The evidences of conformity with the Annex I of the IVDR shall be placed in this chapter. Usually, a template is used containing different columns: (1) the requirement, (2) its applicability status, (3) the method(s) used to demonstrate conformity with the requirement, (3) the standard(s) applied, (4) the controlled documents offering evidence of conformity.
5. The Benefit-Risk Analysis & Risk Management
Here you shall describe the Benefit-Risk Analysis, the mitigation plan and the results of the risk management (according to the Annex I of the IVDR – General Safety and Performance Requirements). Note: In Europe, the ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices. This ISO norm is recognized by the U.S. FDA.
6. The Product Verification & Validation
This chapter shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of the IVDR and in particular the one mentioned in the Annex I of the IVDR – General Safety and Performance Requirements. Three major things shall be referenced in this chapter:
The Clinical Evidences of the device, including a Performance Evaluation Plan and a Performance Evaluation Report (Analytical Performance Report, Clinical Performance Report, Scientific Validity Report).
The Stability Studies of the device, including a Stability Studies Protocol + Report.
The Software Validation Evidences (if necessary), including a Software Validation Protocol + Report.
7. The Post-Market Surveillance
This chapter shall contain the Post-market Surveillance Plan and Report, including a Post-market Performance Follow-up (PMPF) plan and a Periodic Safety Update Report (PSUR).