As a medical device manufacturer planning to sell your devices in the European Union (EU) market, you will first need to demonstrate compliance with EU regulatory requirements. You will ascertain this conformity by preparing meticulous information about the design, composition, intended use, claims, and clinical evaluations of your medical device, and submit the same in the form of a Medical Device Technical File (also referred to as Technical Documentation).
The medical device technical file is a necessary step in the approval process, meaning it is an obligatory regulatory document.
But what exactly goes into a medical device technical file?
And how do you structure it properly?
In this article, we’ll answer these questions and more.
The topics that we will cover include:
- What Is a Medical Device Technical File?
- When Is a Technical File Required?
- Importance of Medical Device Technical Documentation
- Medical Device Technical File Requirements
- Medical Device Technical File Contents
- Medical Device Technical File Example
- Medical Device Technical File Checklist
- How is a Medical Device Technical File Reviewed?
- Software for Managing Medical Device Technical File
- Frequently Asked Questions About Medical Device Technical File
What Is a Medical Device Technical File?
A medical device technical file is a mandatory technical document that your medical devices company will submit to the concerned regulatory authorities in the EU to get approval to sell your medical devices. You will demonstrate that the medical devices that you intend to sell are safe, efficacious, and are solely for their intended use.
If you look at the North American market, you would have made a 510(K) or a regulatory submission to the US Food and Drugs Administration (US FDA). Well, a medical device technical file is similar but is meant for EU regulatory agencies.
Before getting the Conformitè Europëenne (CE) Mark for your medical devices, you will submit the medical devices technical file. It is a requirement for complying with the following regulatory requirements – Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, and Active Implantable Medical Devices Directive 90/385/EEC.
Rather than waste precious time and utilize scarce resources in searching for the required documentation when you go about compiling your technical documentation, you will be better off using integrated QMS software for medical devices such as SimplerQMS.
The SimplerQMS software provides a set of readily available forms and allows you to link your design control records.
When Is a Technical File Required?
If your medical devices company manufactures different classes of medical devices, and you wish to market the same in the European Union, you will require a medical devices technical file for all these devices.
The exceptions to this rule are Class 1 medical devices that are not supplied sterile, and which do not have a measuring function. These products are classified as lower-risk medical devices and need only a self-declaration. You do not require the permission of a Notified Body for the review of technical files.
Self-declaration here means that your medical devices company will declare to the concerned regulatory authorities that these particular devices are following requisite standards. Basically, you are taking the legal responsibility of defining the legal framework of certain medical devices, which would otherwise have been done by a third party.
If you are interested in learning more about the different classes of medical devices, check out this guide on medical device classification.
Irrespective of the class of medical device, or the pathway you are considering taking to enter the EU market, you will need a technical file. If you are planning to approach a Notified Body for your regulatory requirements, they will explicitly verify your technical files.
The SimplerQMS software solution provides a single, safe repository for all the necessary documentation for each and every product that your company is submitting for CE Marking or 510(K) submission.
Importance of Medical Device Technical Documentation
At the heart of the approval process for your medical devices is the medical device technical documentation. This file is not only required for approval to sell your medical devices in the EU, but they are also subject to regular inspection by the US FDA and ISO 13485:2016 audits.
Your medical devices company will meticulously plan and prepare the technical documentation right from the beginning of the development process of a medical device. This implies that the preparation of the technical file goes hand-in-hand with the product development.
Ensure that the technical file is compiled in a clear and organized format. It must be regularly reviewed and kept up-to-date for all your medical devices.
By utilizing robust document control capabilities built-in SimplerQMS solution, you are assured of documentation that is always audit-ready. Whether it is technical files or any other records and approvals for a given product, you are assured of a single repository for all versions, audit trails, and electronic signatures. Plus, you can easily schedule periodic reminder tasks to ensure your documentation is kept up to date.
Medical Device Technical File Requirements
According to the EU declaration of conformity (DoC), the essential rules that your medical devices company must follow when placing your products on the market are as follows:
- Before placing your product on the market, ensure that the technical documentation is ready.
- As soon as you have placed the product on the market, the market surveillance authorities may request the technical document. You should ensure that it is readily made available to them.
- The technical documentation should be kept updated for a period of 10 years from the date you have placed a particular product on the market. This time frame is mandatory unless unequivocally specified elsewhere.
According to Annex II of the EU MDR 2017/745, the medical device technical file should contain, at the least, the following:
- Description and specification of your medical device
- Detailed labeling and packaging information
- Instructions in all the official languages of the member states of the EU
- Information from the sites where your company’s design and manufacturing activities are conducted
- Pre-clinical and clinical data
- Post-market surveillance planning and report
- Declaration of conformity
Section 4.2.3 Medical Device File of ISO 13485:2016 states the following.
“For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.”
ISO 13485:2016 section 4.2.3 continues by stating the content of the medical device file(s) shall include, but is not limited to the following.
– general description of the medical device, intended use/purpose, and labelling, including any instructions for use;
– specifications for product;
– specifications or procedures for manufacturing, packaging, storage, handling, and distribution;
– procedures for measuring and monitoring;
– as appropriate, requirements for installation;
– as appropriate, procedures for servicing.
Outside of the EU, MDR does not apply anymore. Hence, different rules will naturally apply.
If we look at the US FDA, they require detailed device documentation in the form of three distinct files, which, when combined, are similar to the EU’s medical device technical file.
These files are:
- Design History File (DHF): This file will demonstrate to the FDA that the medical device’s design was in accordance with an approved design plan.
- Device Master Record (DMR): The DMR contains the complete specifications of the medical device and the specifications for the production processes.
- Device History Record (DHR): This file needs to contain the following information – dates of manufacture of the product, quantities manufactured and released for distribution. It should also contain the unique device identifier (UDI) or universal product code (UPC) or any other product identifier.
Medical device QMS software like SimplerQMS makes your documentation processes simple and quick, because of its single repository format for all design documentation, including drawings, reports, notes, images, and videos. Your company can easily reference these files for protocols, procedures, components, suppliers, types of equipment, and processes.
In this manner, you will be able to effortlessly create fully traceable and regulatory compliant technical documentation.
Medical Device Technical File Contents
The technical documentation that you maintain for each of your products must be properly structured.
This is of utmost importance since it will help the regulatory inspectors clearly understand the contents of the medical device technical file.
Furthermore, when the technical documentation is properly structured, you are benefitted by being able to readily access different sections to update them as and when required.
The contents of the medical device technical file should contain, at the minimum, the following details according to the EU MDR 2017.745:
- Description of the device and specification: In this section, you will include the product or trade name, along with a general description of the medical device. You will also include a unique device identification (UDI) number for each medical device.
- Labeling and usage instructions: This section will contain the device labels and their packaging details. Depending on the member state where you plan to market the device, the instructions should be in the official language of that state.
- Design and manufacturing details: Here you will provide information on the various design stages of the device. Also, information and specifications on the various manufacturing processes.
- Safety and performance requirements: You will provide evidence stating that the device is safe and performs according to its intended purpose.
- Product verification and validation: In this section, you will provide pre-clinical and clinical data to verify and validate your medical device.
To find out more about the various technical documents required by the MDR, see Annex II (Technical Documentation) and Annex III (Technical Documentation on Post-Market Surveillance).
Most medical device technical files follow the Summary Technical Document (STED). This document brings standardization for medical device submissions to regulatory agencies across markets.
At present, STED is recognized by Europe, the USA, Australia, and Japan.
Some Notified Bodies across Europe also publish extensive documents that describe how technical files need to be formatted.
Medical Device Technical File Example
Here is an example of what a medical device technical file folder structure could look like in the SimplerQMS solution.
Worth noting that the same documents in the SimplerQMS software can be related to multiple archives, such as medical device technical files, CE marking, 510(K), DMR, DHF, and DHR.
This is very useful as it prevents duplication of the same file.
Here is another example of how you could structure, for example, your Design History File in SimplerQMS.
Lastly, when it’s time to compile your technical documentation, for example, for a regulatory submission you can easily make a snapshot of current documentation for each product and share it externally.
Medical Device Technical File Checklist
The main checklist items that your company should remember when structuring the medical device technical file are as given below.
- Device description and specs: This will include a general description of the product, including technical specs, and product/trade name with the UDI.
- Information supplied by manufacturer: Here, you will provide the instructions for use (description and specifications, purpose, warnings – if any, and precautions). In addition, this section will contain information on packaging and labeling, with hazard symbols, handling instructions, and manufacture and expiry date.
- Design and manufacturing information: In this section, you will explain the schematics of the design of your product or design controls, the manufacturing process, information on all manufacturing sites, and the various quality control protocols.
- General safety and performance requirements: You will include the verification and validation report (which will include amongst other details, biocompatibility testing documentation), comprehensive clinical evaluation reports, biological evaluation reports, and post-market surveillance plan and reports.
- Risk assessment: The risk assessment section of your technical file must contain all details about the product safety risk management system right through the lifecycle of your product.
- Declaration of conformity: We know that the medical device technical file is a mandatory document. In this regard, the last section of the document will have the names and signatures of the manufacturer or authorized representatives declaring that your products comply will all required EU regulatory requirements.
How is a Medical Device Technical File Reviewed?
For conformity assessment, the concerned Notified Body will review the technical documentation that you provide in accordance with the classification of the medical device.
This means that each device is assessed based on a risk-based approach.
The benefits of the medical device must offset any risks. Or, any perceivable risks must be reduced as much as possible and such risks should be acceptable considering current state-of-the-art technologies.
Also, these risks should be acceptable across the validity period of the certificates.
Let us take a closer look at the different classes of medical devices:
- All Class IIb active devices, Class IIb implantable devices (there are some exceptions), Class III devices, and Class III implantable devices will be assessed individually.
- Other Class IIb medical devices are assessed using at least one device that represents each generic group. This is also the case for Class II devices in general.
- When Class I devices are considered, those devices that are supplied in a sterile condition, have a measuring function, or have reusable surgical instruments, will be evaluated only for these features. For all other Class I devices. You will declare the conformity of the products.
Now that the medical device technical file is complete and it is time for submission to a Notified Body, it is good practice that your company internally reviews the documentation.
Also, it is a good idea if you carry out an internal audit of it, using a cross-section of personnel from different departments.
You could also choose an external medical device consultant to do the same. If you are curious about key areas to consider when choosing the right consultant, feel free to read the article on how to choose the right consultant for your medical device organization.
SimplerQMS allows you to easily prepare your medical device technical file for review. Using a Document Collection Tool, you can make a “snapshot” of the current documentation status of each product. Once the documentation is complete, you can easily and quickly export the files and share them, for example, with external consultants who have been hired to audit your technical files.
Software for Managing Medical Device Technical File
If your medical devices company is still using a manual paper-based system for documentation and other purposes, you will likely have faced many obstacles, including lack of storage space, issues with security, editing, cost, and transport within and outside the organization.
You will also note that paper-based systems limit your ability to collaborate and communicate.
If you look specifically at the medical device technical file, it is clear that it is a living document, in the sense that it has to be up-to-date within the medical device quality management system.
This becomes difficult if your company is still into manual paper-based systems.
These problems are easily eliminated with a robust medical device QMS software solution such as SimplerQMS.
The advantages are many, for example:
- The development of your medical device is accelerated since systems, documentation, and records are all linked in a centralized storage location.
- You can use readily available forms for documenting product development. Else, you can migrate your own forms and procedures into the system.
- You are well prepared for any audit since all records and approvals for any specific product with versioning, audit trails, and electronic signatures are readily available in a single, cloud-based storage location.
Frequently Asked Questions About Medical Device Technical File
What Is the Difference Between Technical Files and Design Dossiers?
The main difference between technical files and design dossiers is that technical files (also referred to as technical documentation) are needed for all Class IIa and IIb medical devices and Class I devices, whereas the specific technical documentation for Class III medical devices is labeled as design dossiers.
This means that in the EU, design dossiers are used for the higher-risk medical devices (namely, high-risk Class III medical devices).
If your company has submitted a Premarket Application (PMA) for a Class III product to the US FDA, you will understand that the design dossier plays a similar role in the EU.
What Is the Purpose of a Technical File?
The purpose of a technical file is to demonstrate to the regulatory authorities in the EU that your medical device conforms to all applicable and current regulatory guidelines.
What Is Technical Documentation in the MDR?
Technical documentation in the MDR is a mandatory requirement. Your company will compile all relevant documents pertaining to a medical device through the entire lifecycle of the product.
As a medical devices manufacturer wishing to sell products in the EU market, you will mandatorily need to maintain the complete information about each product throughout its lifecycle.
This documentation is called the medical device technical file.
Since the medical device technical file is a living document that has to be up-to-date with your QMS. This becomes difficult if you are continuing to use manual paper-based documentation systems that have too many lacunae.
With the use of the robust SimplerQMS software solution, you are at an advantage as compared to your competitors.
If you aim to streamline the management of your medical device technical documentation, we recommend you are booking a tailored demo of the SimplerQMS solution today and consult our system experts.