Technical Files: Documenting the Justification for CE Marking

There are many routes that lead to the final objective: medical devices that possess CE marking. However, the article on conformity assessment didn't mention that manufacturers may encounter some roadblocks along the way. Just as tollbooths, traffic congestion and speed limits can slow one down while driving on European motorways, manufacturers similarly must navigate through many additional obstacles to demonstrate conformity assessment.

One element of the route to conformity assessment is a compilation of the technical documentation, commonly given the monikers "technical file" for Class I, Class IIa and Class IIb medical devices and "design dossier" for Class III medical devices. Interestingly, these terms (including the term "technical documentation") are not referenced in the articles of the Medical Device Directive (MDD) 93/42/EEC.

What Regulatory Documentation Is Required?

The contents of a technical file or design dossier are described within the appropriately selected route to conformity assessment (see the MDD's annexes) - the route is partially contingent on the device's classification. No format is prescribed for the technical documentation, and any of the multiple formats circulating are sufficient, provided all the elements delineated in the annex are included and the relevant Essential Requirements (ER) in Annex I are met.

Note that, according to paragraph 10 of Article 11, if notified body (NB) involvement is required, the NB is permitted to request, "where duly justified, any information or data which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure." The specific details in the documents depend on the type of medical device and on what would be technically required for the manufacturer to demonstrate the conformity of the device with the ER. To some extent, themanufacturer determines and justifies the testing and documentation sufficient to assure the device complies with the directive.

Available Guidance for Technical File Content

Many entities have published guidance documents on the topic of technical file content. In particular, if a manufacturer already has identified a NB, it is recommended that the manufacturer request guidance from the NB as well. Some NBs have published rather extensive documents describing their position. And, it is presumed that the NB reviewer assesses the documentation based on a checklist developed from its guidance document. While it is not necessarily advocated, some manufacturers change NBs, and it should be considered that NBs may have their own unique expectations about the appearance of the technical file.

For the most part, however, technical files and design dossiers are viewed as controlled documents. Most NBs expect the pages be numbered for easy identification and review. It is advisable that the information be presented in an organized, concise and coherent manner to facilitate review by the NB, if applicable, as conclusions and synopsis. Tables and flow charts are effective mechanisms to provide summary results. Generally, documents that demonstrate compliance with the ER are summarized in the text of the technical file or design dossier and included as an attachment or appendix.

Common Elements of a Technical File/ Design Dossier

The initial intent of this article had been to propose a format for the technical file. After reviewing five guidance documents, however, it became apparent that format is subjective. The survey of formats provided the following number of sections: 4, 7, 9, 11, and 12. Furthermore, even determining what constituted a "section" required interpretation. Still, there are some general elements to keep in mind when preparing the technical file.

A technical file may be considered one document divided into different sections. The reports or documents that support the contents of the sections and the ER should be appended to the technical file as an appendix or attachment. In certain circumstances, these supporting files may be referenced. In addition, the following elements are recommended, though this discussion is not exhaustive or prescriptive.

Description about the device. This section likely would include the following information: design, characteristics, performances, representative images, variations in the family, intended purpose, patient population, medical condition, accessories, brief market history, classification (see Annex IX, Classification Criteria) and rationale as well as conformity assessment route selected. This also may be an appropriate section to add data related to the device's materials.

An ER checklist. The ER checklist should be reproduced verbatim from the directive and presented as a table with labeled columns such as ER, applicable applied standard, demonstration of compliance and location of documentation. The manufacturer is advised to address each ER and indicate whether it is applicable. If the ER is applicable, the standard or procedure used should be referenced, as should the explicit document meet the requirement and the location of the document. A reviewer should be able to identify the specific document. If the ER is not applicable, it is recommended that an explanation be provided. Note that conformance with European Norm harmonized standards published in the Official Journal of European Communities presumes compliance with the ER (Article 5).

Theoretically, the ER checklist should be used to guide design and development of the medical device. It often functions as a signpost that allows identification and location of the supporting documentation.

Risk assessment. The conclusion derived from risk assessment activities should be discussed, and the risk assessment document should be included as an attachment. Use of ISO 14971:2007 is encouraged (for more information, see "Euro News"in the July/August 2007 issue of MPO).

Bench testing. Manufacturers also should include a synopsis from the various test reports that substantiate the device's performance and safety: in-vitro performance or safety; mechanical, physical, chemical and/or animal studies; biocompatibility; packaging; shelf life; stability; and sterilization. (Note: The manufacturer may elect to address packaging, shelf life and sterilization in separate sections.)

Manufacturing. A manufacturing flow chart and rudimentary description of the method of manufacturing should be provided to demonstrate inspection and preventive monitoring steps, conditions of manufacture, quality system certifications possessed by themanufacturer or critical subcontractors, labeling control and traceability. A flow chart can be particularly informative when contractors perform multiple functions or when the manufacturer is a"virtual"manufacturer that relies heavily on outsourcing.

Clinical evaluation. This document recently was described in the January/ February 2008 "Euro News" column in MPO. Basically, a summary from the clinical evaluation report should be provided, with the
actual report attached to the summary. Many technical files, particularly those for Class I and IIa devices, lack a respectable report, which may become an issue when Directive 2007/47/EC is transposed into national law (Dec. 21, 2008) and applied (March 21, 2010).

Labeling. Draft labeling should be included, and it is permissible to include the CE marking with the four-digit NB identification number, if relevant. Use of symbols, particularly those described within EN 980:2003, are encouraged.

Declaration of conformity. This document should be issued as a draft; however, each NB and reviewer may have its own expectations as to what the document should contain (ie, there is no "one size fits all" standard). This document, which could reference the number of the NB-issued CE marking certificate, is signed and issued after the manufacturer has met all the requirements of the directive.

Two More Universal Format Guidances

Two format guidances also worth reviewing were issued by the Team Notified Body NBMED and the Global Harmonization Task Force (GHTF) Study Group 1 (for more information, read "Euro News" in the March 2008 issue of MPO). Both guidance documents present a format that may be applied. No MEDDEV has been published on the topic.

In the interests of harmonizing the regulatory requirements among different jurisdictions (GHTF members: Australia, Canada, the European Union, Japan and the United States, as well as other signatories), the summary technical documentation may be used to describe how the device was developed, designed and manufactured and also demonstrate how the device meets the "Essential Principles of Safety and Performance of Medical Devices." Then it may be submitted as the regulatory documentation for all GHTF members, not withstanding country specific requirements.

The recast is a fascinating document, especially since eight months earlier Directive 2007/47/EC was published, and months were invested to negotiate the provisions of the revision. That said, with this recast the European Commission has presented many propositions and ideas to address inadequacies of the system. The European Commission truly was fishing for opinions, so it will be worthy to note the outcome. Obviously, everything in life requires improvement; however, some of the modifications seem like a wholesale revision.

June 2008