This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity to the Medical Device Directive 93/42/EEC (MDD). It is intended to provide an overview for regulatory professionals who seek to compile technical documentation for review by European notified bodies (NBs) and for those involved in providing information used within technical documentation who may be less familiar with the overall requirements. Emphasis has been placed upon the executive summary section of the technical documentation, (or Part A, as referred to in NB-MED/2.5.1) as a means of addressing the key requirements succinctly.

Typical instances whereby NBs review such technical documentation include:

  • Design Dossier or Type Examination for Class III devices (Annex II.4 or Annex III MDD)
  • Review of a design dossier is performed when manufacturers wish to:

•   CE Mark a new device

•   make a substantial change to an existing device

•   renew (or transfer from another NB) the design examination certificate

  • Technical File for Class IIa and IIb devices
  • Technical files are reviewed, usually on a sample basis, during an initial technical audit and for subsequent continuing technical audits in order to secure and maintain quality management certification (Annexes II.3, V and/or VI of the MDD).
  • Technical files are also reviewed when a manufacturer wishes to expand its quality management certification scope. In this scenario, the devices representative of the scope extension are reviewed.

For more information regarding the overall CE Marking process, please refer to a previous article by Ms. Laurel Macomber entitled, “MDD Regulations: What I Wish I Had Known” in the Autumn 2010 issue of BONEZONE.

Recommended Format

NB-MED/2.5.1 recommends that the technical documentation be subdivided into two parts. The first part is a summary of the essential technical data relevant to the conformity assessment procedures, as well as some necessary administrative information. This section is referred to as Part A in NB-MED/2.5.1 “Technical Documentation.” The second section, Part B, consists of the appropriate reports necessary for conformity assessment such as risk assessments/risk management report; clinical evaluation; design verification and validation reports; technical drawings/product specification report; manufacturing, sterilization and packaging validations; instructions for use/labeling/surgical technique & technical monographs/white papers; etc.. For the purposes of this article, Part A will be referred to as the executive summary.

The provision of a comprehensive and well-formatted executive summary, with links or references to the main body of the document Part B, facilitates a quicker review of the information. This format also enables effective management of the technical documentation and allows for updates to be made more easily when necessary.

All documentation should be clearly specific to the devices under review. If generalized material is provided, the relevance to the devices under review should be explained.


In general, searchable, electronic documentation formatted into one PDF file with bookmarks will facilitate a faster review. Documents that are scanned cannot be searched, unless saved as searchable PDF files, and often have large data memory size. Documents that are converted to PDF from another format such as Word can be searched, and this is the preferred method. Pages that have signatures can be scanned and added separately into the PDF file.

Some suggested detail is provided below from NB-MED 2.5.1, GHTF STED and NBOG BPG_2009_1.

Content of the Technical File

Manufacturer: Name and address of the legal manufacturerand any additional manufacturing sites covered by the quality system.

EU Authorized Representative: Name and address of the authorized representative if the Legal Manufacturer is located outside the European Economic Area (EEA).

Design Location:Name and address of the location site having design control.

Identification of Technical Requirements: The manufacturer should make clear the Directive(s) which apply to the particular device(s) concerned, including Directives other than the MDD. Where not self-evident, the manufacturer should document the rationale for classifying as a medical device and deciding what other, if any, requirements apply.

A statement of the conformity assessment procedure or route being followed should also be provided.

Product Lifetime: A statement regarding the lifetime of the device during its intended clinical use is required.

Product Description: Brief description to allow for understanding of the design and performance requirements. A product specification should list the features, dimensions and performance attributes of the medical device. Pictures, 3D computational renderings or schematic diagrams are beneficial. Provide information on the materials used to construct the device and any standards or specifications to which the materials conform. Describe any novel features of the device. Describe the principle of operation or mode of action for the device. Include the trade or proprietary name(s) if applicable, the common or usual name(s), the device classification and rule assigned by the manufacturer in accordance with the MDD Annex IX, and the GMDN code. The manufacturer may cross-reference technical drawings provided in Part B.

List the various configurations/variants of the device. A tabulated catalogue item listing of the devices covered by the technical file with a brief description for each device (detailing variation, e.g. sizing, with or without coating, left or right components, etc.) should be provided. This information may also be provided by cross referencing the Declaration of Conformity which should detail the devices it covers in this format.

List any accessories that are required to be used with the device. Any accessories packaged with the device should be described in full, and detailed in further sections of the technical file as applicable.

Intended Use: A description of the intended purpose including key indications and contraindications; may include patient population, medical condition, whether for professional use, etc. This information should be consistent with that in the instruction for use which may be cross-referenced. If the indications are in any way novel, further information may be appropriate.

Declaration of Conformity: The declaration of conformity may be included within either part of the technical documentation. If placed in Part B, a reference to it within Part A is beneficial. This declaration for design dossier reviews should be an unsigned draft version, complete but for the dated signature pending issue of the design examination certificate.


Design Verification & Validation: A listing and summary of the solutions adopted to fulfill the relevant essential requirements. This summary should contain the following:

  • Overall review of all the testing & analyses performed (e.g. FEA, design comparisons, Range of Motion analyses, bench tests, in vivo animal models, cadaveric sessions/surgeon feedback) and how this compilation of data is believed to address all of the applicable essential requirements. Provide justification for any applicable testing that has not been carried out on the device. Confirm that all design input requirements have been met or provide a rationale if certain requirements have not. A design input & output test matrix is beneficial in succinctly presenting this information.

o        Summary information on each test report. Things to consider:

•         What was the objective?

•         If applicable, were the acceptance criteria met?

•         If relevant and evaluated, describe the worst case scenario

•         Briefly detail materials & methodology (include number of specimens)

•         Were the actual devices under review in their final finished form tested, including sterilization? If not, provide a justification. For technical files containing multiple variants, the specific catalogue number(s) of the product tested should be included.

•         Summarize data and any statistical analyses

•         What were the clinical safety and/or performance implications/relevance of the data?

  • Mention any applicable standards or specifications that were complied with. Provide justification if an applicable harmonized standard was not complied with.
  • If the device is intended to be to be used in combination with another device (or devices) for its intended use, proof must be provided that it conforms to the Essential Requirements when connected to any such device(s) having the safety and performance characteristics specified by the manufacturer.

Essential Requirements (ER) Checklist: The manufacturer is required to demonstrate how each of the applicable essential requirements and any derived technical requirements/specifications for the particular device(s) concerned have been met. An ER checklist should be provided. If provided within Part B, a cross reference to it should be provided in the executive summary. Guidance on the format of the ER checklist is provided in the GHTF and NB-MED articles cited below. Note that essential requirements listed as not applicable should be supported by a justification statement. Cited documentation in support of demonstrating compliance should be traceable. Ensure that the ER checklist is updated in accordance with amending directive 2007/47/EC. (As with the entire MDD 93/42/EEC changes made by amending Directive 2007/47/EC to the Essential Requirements in Annex I are easily identified by “M5” appearing alongside in the left hand margin.)

Technical Standards and Regulations: Provide a complete listing of all relevant standards and regulatory requirements to which the devices comply.

Market History: For devices already on the market within the EEA and/or for devices under review for CE Marking that are already marketed in other geographical territories, a brief description of market history should be provided. Manufacturers may also choose to provide market histories for devices deemed similar to the device under consideration. This summary should contain an overall breakdown of sales volume and number of complaints over a stated time interval (with a justification) with comments regarding complaints trending; number of reportable incidents with brief descriptions; recalls; corrective action.


Manufacturing Processes: Summarize key processes, including any special processes (e.g. crosslinking polyethylene, coatings and surface treatments) from receipt of raw materials through to packaging and terminal sterilization. Include the name and address of the location sites where each process is carried out, along with any quality systems certification that these sites possess. Include cleaning and inspection procedures. This information may take the form of a process flow chart. Validation reports to support the various processes may be provided in Part B.

Sterilization: Sterilization validation reports will typically be provided in Part B and should be referenced to in the executive summary. Within the executive summary, mention the sterilization site(s) (name and address), methodology and standards with which the sterilization process and validation complies. Quote the established sterility assurance level. Evidence of the ongoing revalidation of the process should also be provided.

Packaging: Packaging validation reports will typically be provided in Part B and should be referenced to in the executive summary. Within the executive summary, describe the materials and design used in the construction of the packaging. Summarize the packaging integrity and transit testing conducted and standards with which the packaging complies.

Shelf Life: The device’s shelf life should be stated in the executive summary. This shelf life needs to be supported by the packaging and sterile barrier integrity data as well as device aging/stability data which may be provided in Part B.

Biocompatibility/Biological Safety: Provide summary information regarding how the devices under review complied with the relevant harmonized standard(s). Summarize the testing and analyses conducted. Provide rationales for why any recommended or suggested testing from the relevant harmonized standard was not conducted. Provided rationale for any testing that was not conducted on the finished and sterilized (if applicable) device. Test reports may be provided in Part B.

Further information will be required if the device contains animal tissue, phthalates, human blood derivatives or medical substances.

Medicinal Substances: State whether or not the device incorporates a medicinal substance.

Human Blood Derivatives: State whether or not the device incorporates human blood derivatives.

Animal Tissues: State whether or not the device incorporates animal derived substances or utilizes animal derived substances during manufacture.

Phthalates: Does the device contain phthalates?

Risk Management: Risk management documentation, such as the risk management plan, risk management report and risk assessments, may be provided in Part B. All aspects of risk relating to manufacturing, design and clinical use should be addressed. A summary of the risk management file within the executive summary should contain:

  • brief description of the documents provided in Part B
  • any standards which were complied to
  • the methodology employed (e.g. Failure Modes And Effects Analysis, Fault Tree Analysis)
  • brief description of how risks were calculated and categorized
  • Statements regarding the following questions should be provided:

o        Has the risk management plan been appropriately implemented?

o        Is each risk within acceptable limits?

o        Are the overall residual risks acceptable?

o        Are appropriate methods in place to obtain relevant post-production information?


Clinical Evaluation: The clinical evaluation may be provided in Part B. Within the executive summary, it is beneficial to provide a link or cross-reference to the clinical evaluation, along with a summary. A good summary will contain the following:

Number of articles used in the critical review. State database and search terms employed for the literature search. Provide an overview of total number of patients/procedures covered within the reviewed clinical data and average follow-up length. State whether or not clinical data on the actual device is reviewed, and summarize the data if available. Brief description of any similar devices used to provide clinical data. Mention any standards or guidance documentation that was complied to. Were any new risks identified? Was a clinical investigation deemed necessary? Do the clinical benefits outweigh the risks? Does the clinical evidence demonstrate conformity with relevant Essential Requirements? Based on the critical review of the clinical data, summarize the established quantitative safety and performance of the device for its intended use.

For more information regarding clinical evaluation requirements, please refer to a previous article by Dr Amie Smirthwaite entitled, “Notified Body Requirements for Clinical Literature Evaluation” in the Winter 2010 issue of BONEZONE.

Post Market Surveillance: Post market surveillance data may be provided in Part B for devices already marketed in the EEA and/or other geographical territories. Data may be summarized within the executive summary. A postmarket surveillance plan should also be provided specific to the device under review. Typically, and especially for new devices, a postmarket clinical follow-up (PMCF) study is expected as part of this plan. The elements of the postmarket surveillance plan can be provided within the executive summary along with a brief description of the PMCF study. There should be an adequate rationale if a PMCF study is deemed unnecessary.

It is recommended to detail how often key documentation used to demonstrate conformity to the Essential Requirements will be updated in response to information gained during post market surveillance.

Device Changes: Statements regarding changes to the device (e.g. dimensions, design, materials, manufacturing processes and locations, indications, surgical technique, product specifications, etc.) should be provided. The technical documentation should include records of each design change and the reasons for these, together with any associated verification/validation data. The documentation should include evidence for believing that the change achieves the desired effect, and that the device continues to comply with the requirements of the MDD.

Software: Does the device incorporate software or electronic programmable systems?

Energy Source: Does the device depend on an internal or external power supply?

Information supplied to the User: List the information provided in Part B. Labeling and the instructions for use are required. If available, surgical technique guides and technical monographs/white papers should also be provided. This material may be provided within the executive summary to supplement the description and intended use information.


This article provides an overview only and focused upon content for the executive summary. It does not intend to provide an exhaustive inventory of technical documentation requirements. The applicability of this article will diminish over time based upon updates to the MDD, NB-MED, NBOG and GHTF guidance, relevant harmonized standards and other state of the art sources. This information does not constitute formal BSi opinion in any way. Manufacturers are ultimately responsible for how information is formatted, compiled and updated for their devices in support of demonstrating compliance with the MDD.

ADDITIONAL RESOURCES

Global Harmonized Task Force, GHTF SG 1, “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED).” www.ghtf.org/sg1/sg1-final.html

NB-MED/2.5.1, “Technical Documentation” www.meddev.info/index.htm

NBOG_BPG_2009_1 “Guidance on Design-Dossier Examination and Report Content.” www.nbog.eu/2.html

Hamish Forster has served as Product Expert, Orthopaedic & Dental Team, at BSi Healthcare since 2007. Prior to that, he was a Research Project Manager with Smith & Nephew. He worked at Smith & Nephew for 11 years; three years at their Research Centre in York, England and eight years at their Orthopaedics Division in Memphis, Tennessee. He gained his Doctorate and was a Research Fellow at the School of Mechanical Engineering, University of Leeds prior to joining Smith & Nephew. His projects related to bone graft substitutes, synovial joint lubrication, bone cements, hard-on-hard bearing surface technologies, antibiotic coatings, metal-on-metal & ceramic-on-ceramic hip arthroplasty tribology, UHMWPE wear debris characterization and technology scouting. Dr. Forster may be reached at 901-725-8983 or This email address is being protected from spambots. You need JavaScript enabled to view it..

BSi Healthcare
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Continue learning from BSi during OMTEC 2011 by attending the following lectures, to be presented by Suzanne Halliday, Ph.D.

Wednesday, June 15: Getting Started with CE Marking: Your Passport to Europe

Thursday, June 16: Clinical Evaluation 101: A Key Requirement to Gaining Access to the European Market

Detailed abstracts for these lectures are available online and in the Advance Program. Please visit www.omtecexpo.com for the most up to date information.