This article draws from our experience in conducting Tech-File reviews and outlines the key requirements for Technical Files based on Annex II under the MDR. At MedEnvoy, our team of consultants has reviewed over 5,000 Technical Files belonging to manufacturers from different countries and products across the medical device and IVD industry. While our previous blog talks about ‘Technical Documentation Files Review: Top 5+ Mistakes by Manufacturers’, here we cover the Six Sections of Annex II of the MDR as follows:
Technical File preparations: The Six Sections of Annex II under the MDR
Section 1: Device description and specification, including variants and accessories.
Section 2: Information to be supplied by the manufacturer.
Section 3: Design and manufacturing information
Section 4: General safety and performance requirements
Section 5: Benefit-risk analysis and risk management
Section 6: Product verification and validation
Section 1: Device description and specification, including variants and accessories for Annex II documentation:
Typically, while preparing Annex II documents, Section 1 has straightforward requirements. Product/accessories description, novel features, Basic UDI-DI, risk classification, and predicate information. form a part of Section 1. The intended purpose, intended users, and patient population should also be added as well as the rationale for the Qualification of the Product as a Medical Device. The Principles of Operation of the Device and the Mode of Action supported by scientific evidence should also be included. If the device has any novel features, it is expected that a detailed description of the novel features will be included. The Device Risk Class and Classification Rule Justification should be documented. If multiple classification rules apply, identify all and apply the strictest rules resulting in higher classification. Also, raw materials, critical coatings for device safety and performance, and the nature of contact with the human body (direct or indirect) should be identified, including raw materials used in primary and secondary packaging. Furthermore, Section 1 of Annex II requires an overview of the previous generation or generations of the device, where applicable. Also, an overview of identified similar devices available on the Union or international markets is required.
Section 2: Information to be supplied by the manufacturer:
Section 2 of Annex 2 indicates that the technical documentation must include the information that accompanies medical devices when supplied to the end-user (i.e., the labels and IFU). In-depth labeling and IFU requirements are provided in Annex I Chapter III. For the EU market, it is important to note that these documents that accompany your medical device must be provided in the languages accepted in the Member States where the device is being sold. MedEnvoy offers European Authorized Representation Services to manufacturers selling in the EU and as a part of the due diligence helps you verify whether your device’s label and IFU fulfill the requirements of the MDR. For more information about our EU Authorized Representation services click here.
Section 3: Design and manufacturing information:
Section 3 details device design input and output stages, its manufacturing process and flowchart, and a list of manufacturing sites and critical subcontractors/suppliers. It is important that the process used to manufacture the device is clearly outlined and validated. The design requirements need to be clearly defined and the final version document controlled.
Section 4: General Safety and Performance Requirements (GSPR):
To ensure compliance with the General Safety and Performance Requirements (GSPR) in Section 4 of Annex II, all GSPRs shall be addressed, providing a rationale for the applicability or non-applicability of each requirement considering both main clauses and sub-clauses. Simply saying a requirement is “N/A” is not sufficient, a rationale for why the requirement is not applicable must be provided. Also, the methods adopted to demonstrate compliance and the most appropriate current harmonized standards with complete versions, such as EN ISO 14971:2019, EN ISO 13485:2016, EN ISO 15223-1:2021, EN ISO 20417:2021, etc. must be indicated. Some manufacturers fail to provide the full version of the applicable standards (i.e. not including the year or version), this is not acceptable. Where harmonized standards cannot or are not used, the manufacturer should justify the use of other validated methods.
Also, the GSPR should detail the precise identification or reference to the location of the internally controlled documents (plans, reports, and operating procedures) providing evidence of conformity.
Section 5: Benefit-risk Analysis and Risk Management:
Manufacturers must establish Risk-Benefit Analysis and Risk Management in Section 5 of Annex II under the MDR as per the following guidelines:
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- A Risk Management Plan should be available with sufficient details.
- Benefit-risk analysis referred to in Sections 1 and 8 of Annex I
- Solutions adopted and the results of the risk management referred to in Section 3 of Annex I
- Risk control measures as per Section 4 of Annex I,
- Risk management should be done in compliance with EN ISO 14971:2019
Section 6: Product verification and validation:
For the product verification and validation as referenced in Section 6, preclinical and clinical data should be provided. The types of tests to be included depend on the type of device. Manufacturers are advised to use available resources such as guidance documents or harmonized standards to show valid test methods and results. Product requirements, including risk control requirements, should be verified and validated. A Design Input/Output matrix should be provided which shows full traceability. In cases where no further testing was conducted, a rationale for that decision must be provided.
The post-market surveillance (PMS) topic covered under Section 6, Annex II, should be in compliance with Annex III, MDR. The Clinical Evaluation Plan and Report needs to be aligned with Article 61 and Annex XIV. It should be noted that while some devices might justify why clinical investigations are not required under Article 61(10), all devices should have a CEP and CER in place.
Also, the summary of PMS data analysis should include investigations of complaints, recalls/actions, side– (effects, trend analysis, literature reports, database outputs, product preference feedback, and data from other manufacturers. A clear rationale and descriptions of preventive or corrective actions, linked to the risk management file, must be provided. Key findings of post-market clinical follow-up (PMCF) and specific elements of PMS reporting, such as benefit-risk determination and usage information, should also be covered.
Learn more about Annex II of the MDR regarding Technical Files with Medenvoy
If you have any questions regarding Technical Documentation File compilation, would like a gap analysis of your documentation, or require relevant training or consulting services, get in touch. MedEnvoy also provides In-Country Representation Services and Regulatory Importer Services, for more information about our services click here, and to learn more about our subject matter experts click here.