If a product is to be approved for sale in several markets, you should think carefully about how you want to create your technical documentation. It is probably not efficient to create a separate technical documentation (TD) for each country in which you want to sell a product. The human resources needed to maintain this amount of TDs would probably increase immeasurably. To counteract this problem, there are various organizations that have thought about format specifications in order to consolidate the requirements.
Let’s get an overview on the available organizations and formats:
The Global Harmonization Task Force (GHTF) was originally founded in 1992 by the USA, the EU, Japan, Australia and Canada for harmonization purposes. The GHTF worked for years in different study groups. In 2008 the Study Group 1 of the Global Harmonization Task Force (GHTF) published for the first time a guideline titled “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)” regarding the structure of the technical documentation and which provides recommendations on the content of summary technical documentation (STED) to be assembled and submitted to a Regulatory Authority or Conformity Assessment Body.
At almost the same time (in 1996) the Asian Harmonization Working Party (AHWP) was established for the same purpose. The focus here is on certification in Asia and other regions. The AHWP is in cooperation with the GHTF. Today they changed their name from Asian Harmonization Working Party (AHWP) to Global Harmonization Working Party (GHWP) with members from Asia, Africa, Middle East and South America. Reason is to extend their efforts in harmonization from the focus in Asia into a global.
The GHWP also works together with the Association of Southeast Asia Nations (ASEAN). The ASEAN was founded in 1967 with leaders from Indonesia, Malaysia, the Philippines, Singapore and Thailand. Today Brunei Darussalam, Cambodia, Lao PDR, Myanmar and Viet Nam. The aim of the organization is not limited to medical devices, it is more about cooperation in many areas of the economy and culture. The ASEAN provided in 2010 the “Common Submission Dossier Template“ (CSDT) which is intended to provide a common template for the submission of medical device information to medical device regulatory authorities of ASEAN member states (AMS) and in the Annex I also an Essential Principles Conformity Checklist. The ASEAN CSDT document contains elements of the GHTF guidance document. The level of detail of information to be provided under each CSDT section depends on the evaluation route. For example, some AMS may have two evaluation routes: abridged or full evaluation.The CSDT dossier must contain all sections given or at least reason for their non-applicability and must be prepared in English.
The International Medical Devices Regulators Forum (IMDRF) was founded in 2011 as the successor organization of the GHTF, for harmonization and alignment in the field of medical device regulation. Member states of the IMDRF are Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore, South Korea and USA. The world health organization (WHO) is involved as an Official Observer. In 2018 and 2019 the IMDRF published the “Table of Content” (ToC), respective a Guideline for drawing up a ToC. The ToC is another concept for compiling and submitting technical documentation to authorities, notified bodies or any review parts, but also addressing additional documents generally requested with a submission. It is internationally harmonized and could be used in the future for the electronic submission of medical device files to a reviewing body for market authorization.
In 2017 the European MDR has underlined the minimum content of the Technical Documentation in Annex II Technical Documentation and Annex III Technical Documentation on Post-Market Surveillance.This “minimum content” seizes similar chapters the STED and also the CSDT addressed before. However, not all chapters are the same and some additional chapters were added.
Documents usually required for a submission besides the technical documentation
As already stated, a Table of Content submission consists of more than only the “classical” technical documentation. It also covers central aspects of a submission in general. But which aspects are these?
- Technical Documentation
- Good Manufacturing Practice (GMP) or Quality Management System Certificate
- Free Sale Certificate
- Letter of Authorization
- EC Certificate or other certificates if available
- Declaration of conformity
- Certificates of analysis of the final product
- Information on the approval/distribution status of the product
- Application form of the respective country
- associated, country-specific declarations.
Recurring content of the Technical Documentation formats
You are still asking yourself the question: But which format should I use now for basically structuring my technical documentation? Well, this highly depends on your desired target markets. A company only focusing on the European market will probably use the MDR Annex II and III structure for its technical documentation. But, for instance, in case you want to enter the Canadian market, a ToC is sensible as this is the only format accepted by Health Canada besides the traditional format. A classical STED format however, is currently accepted by a wide variety of countries as submission file and may be of interest for those not focusing only on one region.
Each company is individual and should therefore decide on its own which format serves best as basic structure. In the following, the different formats of technical documentation will be compared, and some differences will be pointed out.
Format / Structure
The technical documentation “shall be presented in a clear, organized, readily searchable and unambiguous manner” ((EU) MDR, Annex II). Quite a lot of adjectives, but what do they actually mean? As already mentioned, technical documentation covers more than “pure” documentation. Technical documentation also includes other documents, such as risk management. It therefore makes sense to present the folders to which your technical documentation refers in the same structure as, for example, the table of contents of your technical documentation. This makes it easier for everyone to find the documents again, whether new employees or the Notified Bodies.
The ToC further specifies the presentation requirement from the MDR and gives precise guidelines on the form and structure of the ToC. For example the mentioned folder structure, file and format naming, bookmarking in PDF Files…In general, no matter which format you decide to use, you should work in structured form, even if this is not explicitly required in all formats.
The device description and specification is expected in each of the formats discussed. Annexes II and III of the MDR are very precise here. The other formats describe the requirements in a more general way, which does not mean that these requirements are not also expected in the chapter.
It is also interesting to note that only the MDR requires the Basic UDI-DI. The Basic UDI-DI is a kind of “submission number”. It is comparable with the K-Number in the USA for a 510(k) classification. The general concept of UDI (besides the European Basic-UDI DI) is important for the post market surveillance, but was of course not yet considered in concepts that were established before the IMDRF UDI concept was.
The MDR requires information on 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; (Annex II 1.1 c)). This information is also required in the CSDT format, but is hidden in paragraphs 4.2.2, 4.2.3 Indications, 4.2.5 Contraindications, 4.2.6 Warnings, 4.2.7 Precautions and 4.2.8 Potential adverse effects. The CSDT additionally requires the indication of alternative therapies. The ToC format requires the same information but explicitly asks about pediatric use (2.05.03 ToC).
When defining accessories (Annex II, 1.1 h)), it is important to mention both the items that are covered in the product file and the items that are covered in a separate file or even a separate manufacturer. The CSDT and ToC formats can help with the implementation, as they define the required content in a more detailed way. For example, the ToC requires a List of accessories intended to be use in combination with the device, as well as components or accessories that can be sold separately.
Design and Manufacturing Information
On the topic of “manufacturing process” (Annex II, 3b)), there are clear differences in terms of the level of detail. In the STED, a process flow chart was still considered sufficient, whereas under the MDR, all data must be included entirely in the TD. Under the CSDT, the risk class is relevant for the level of detail.
The requirements for design and production sites (Annex II, 3c) are listed in all formats. While the wording in the MDR is kept quite general, the STED explicitly requires QMS certificates or equivalent certificates to be listed if such exist. The ToC also requires information about the resource management, the purchasing and other Device Specific Quality Management System Information.
General safety and performance requirements
The aim of the technical documentation is to prove that the product is safe and efficient in terms of the applicable General Safety and Performance Requirements (GSPR). The “GSPR Check-list” or “Essential Principles (EP) Check-list” appears in almost every certification and is based on very crucial and basic requirements applicable in the respective target country. If there are no GSPRs / Essential Principles, the countries follow the GHTF/IMDRF Essential Principles. If a requirement is assessed as not applicable, it is not sufficient under the MDR and the ToC to note an n/a, a justification is required.
It is also usually not sufficient to refer to folders or chapters. Both the MDR and the ToC explicitly require a reference to a “controlled document”, which makes it necessary to indicate the version of the document, otherwise it would not be controlled.
There are formal deviations in the area of risk management, but they all build on each other in a similar way: Risk analysis, measures taken, maintenance of the level. In most areas, risk management is expected to be performed in line with ISO 14971 and the national add-ons. For instance the standard has been harmonized in Europe under EN ISO 14971:2019. Therefore only little differences occur when it comes to the general layout and structuring of the Risk Management File, but more when it comes to evaluation details.
Here the MDR, STED and CSDT formats are virtually identical from the middle onwards. Under the MDR and STED, the software development process is also in focus, this should not be ignored when writing the chapters. The ToC deviates from the presentation but calls for a discussion on why the available tests are sufficient.
Where to find the mentioned concepts for technical documentation?
- Common Submission Dossier Template (CSDT)
- Table of Content (ToC):
- Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED):
- Medical Device Regulation (MDR).
It goes without saying that the differences mentioned here do not represent the full scope of the various formats. However, a manufacturer planning to place his medical devices on different markets may realize that planning and combining technical documentation in the light of several concepts may shorten the time to market and also save human resources for maintenance of the same. If you would like to learn more about combined technical documentation concepts, we would be happy to hear from you!
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.