A Technical File is really a document that everyone is looking for when we are talking about EU MDR 2017/745. In this blog post we’ll try to answer most of the questions you have about Technical File or Technical Documentation.
If you want first to have some good content about it don’t miss the podcast episode that was done on the Medical Device made Easy Podcast channel.
Podcast episode-191 How to create your Technical Documentation
Table of Contents
The technical file represents a set of documents that demonstrate the conformity of a product with the CE-marking legislation. The documentation must specify the applicable product safety requirements and cover the design, manufacture, and operation of the product.
The technical file must be available for inspection by the national market surveillance authorities as soon as the product is placed on the European single market, whatever its geographical origin is. Sometimes, the documentation may also need to be submitted to a Notified Body for review.
Usually, the manufacturer or their authorised representative must keep the technical file for at least 10 years from the last date of manufacture of the product. However, some CE-marking directives provide for a different duration (e.g. 5 years according to the MDD 93/42/EEC).
What are technical files for MDR?
According to the MDR, the technical file is a mandatory document for all types of medical devices that must be prepared in a clear understandable language and must be well-organized and readily searchable. It is essential to demonstrate the safety and performance of a specific device.
There is only one category of Medical Devices that don’t need a Technical File and this is for Custom-made devices.
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.
A CE Technical File or Design Dossier is a complete description for a medical device intending to show compliance with EU MDR’s requirements. For a medical device manufacturer, preparing a technical file or design dossier is an essential step in Europe’s CE marketing
What does the Technical File/Dossier Contain?
The content of a technical file is more clear now with the EU MDR 2017/745. We will discuss about that later on this post.
But as a big picture, you just need to look at the Annex II and Annex III of the EU MDR 2017/745 to see what is expected to be seen.
One thing that is also important is to understand the format your Notified Body wants to see it. You have some Notified Bodies that are providing you with a guidance or checklist on how your file should look like.
So don’t forget to ask them if they have specific requirements as this can save you some time and avoid them to be angry at you.
Which Classes of Medical Devices Require Technical Documentation/Dossier?
All medical device products need a technical documentation except Custom-Made Device.
As the Custom-made device are supposed to be unique this is difficult to create a full technical file for it.
So instead, the authorities are asking you to create a statement that is showing that you have followed the requirement per EU MDR 2017/745.
All the other product should normally have a technical documentation even class I products. Sometime people think that as this is a class I self-certified product then there is no need of documentation but this is wrong. Authorities can audit you and ask to see the technical documentation for your class I so you need to have it.
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.
But the only thing is that these technical files will be reviewed by Notified Bodies in Europe.
The exceptions to this last rule are Class 1 medical devices that are not supplied sterile, which are not for reprocessing and which do not have a measuring function.
These products are classified as lower-risk medical devices and need only a self-declaration but no review by a Notified Body.
But the rule is that you should have your technical file ready and approved with a Declaration of conformity before your product is placed on the market. So never place a device on the market without a Technical Documentation otherwise this lead you to non-compliance to EU MDR.
What is the content of the technical documentation?
As discussed before, you need to follow Annex II and Annex III of the EU MDR.
The contents of the technical documentation differ between the different CE-marking regulations.
However, as a rule, the documentation should include at least the following elements:
- A general description of the product (UDI, EMDN, MDR code, class, conformity assessment…).
- Conceptual product design and manufacturing drawings and, where appropriate, schemes of components, circuits, etc.
- Descriptions and explanations needed for the understanding of those drawings and schemes.
- A list of the harmonised and non-harmonised standards applied in full or in part during the conformity assessment process.
- Test reports and risk assessment file.
- Clinical data
- Copies of conformity documentation for critical product components.
- Instructions for use, labelling, brochures…
- A copy of the Declaration of Conformity.
What is the format of the technical file?
There are no legal requirements regarding the structure and format of the technical documentation.
The documentation can be in both electronic and paper format. However, the technical file must always be up to date.
This means that if there are any modifications to the product or amendments in the relevant directives/regulations, manufacturers should update the content of the file.
Now if you ask for advice on the best format, I would say that a File that contains all the Technical Documentation information listed in Annex II and III would be fine, and for all the attached documents, you should reference them in the technical documentation and put them in an annex folder.
The objective is to give to the assessor the possibility to see the big picture and if he needs more details, he then has the opportunity to dig on the reports.
But the format should be easy to navigate as the assessor will spend a lot of time on it. So don’t make its life difficult.
What are the language requirements for the technical file?
The technical file must be written in the official language of the Member State where the conformity procedures are to be carried out, or in which the Notified Body is established, or in a language that is accepted by it.
Typically, all certification bodies accept technical documentation in English. But you may be surprised maybe by a Notified Body asking you another language.
Usually, the things that are mandatory in other languages is Instruction for use and labels if you are supplying products in multiple countries in the EU.
Importance of Medical Device Technical Documentation
At the heart of the approval process for your medical devices is the medical device technical documentation.
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.
- Technical documents are an essential component of introducing a product or service to the market.
- They can have a significant impact on a product’s or service’s financial success.
- Technical documents are an essential component of introducing a product or service to the market.
- They aid in the execution of inspections, audits, and other regulatory requirements.
- Effective documentation can help to avoid incidents and accidents. Many major accidents have occurred as a result of ineffective documentation.
- Product verification and validation, testing, and repairs are all aided by effective documentation.
Technical Documentation and Medical Device Regulation
A Guide for Manufacturers to Ensure Technical Documentation
Complies with EU Medical Device Regulation 2017
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 labelling 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
Medical Device Technical File Contents
The technical documentation that you maintain for each of your products must be properly structured.
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.
- Labelling 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.
Most medical device technical files follow the Summary Technical Document (STED). This document brings standardization for medical device submissions to regulatory agencies across markets.
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.
The Following structure is based on Regulation (EU) 2017/745 (MDR) but it is also suitable for technical documentation according to directive 93/42/EEC. Structure of Technical Documentation (Medical Devices) (mdc-ce.de)
Device description and specification
This will include a general description of the product, including technical specs, and product/trade name with the UDI.
Specifications include product name or trade name along with the basic UDI-DI or any clear identification.
Device Description is the general description, principle of operation, technical specifications, description of any accessories or variants, key functional elements/parts/components/software, and composition.
Check this article on UDI to understand what I mean. Link.
Information to be 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.
INSTRUCTION FOR USE (IFU) – This document must contain your device’s description & specification, purpose and any warnings and precautions. Purpose of the device is the key element in the IFU. It states the intended users along with intended patient, conditions to be diagnosed/treated/monitored, indications, contraindications, warnings, precautions and hazards.
PACKAGING & LABELLING INFORMATION – Under the MDR, in this document you must explain the complete labeling and packaging information. It should also include any description relating to single-unit sales; transport packaging in case of specific management conditions and it must contain symbols for all hazards, warning, handling instructions, date of manufacture and expiry.
Podcast on Label Q & A
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.
- Design schematics, drawings &materials utilized.
- Processes of manufacture.
- Data about all sites, where design and manufacturing activities are performed. All other subcontracted steps or processes involved in the production in any way (such as sterilization, production of a particular part or accessory, or packaging) should be explained along with the full information about name and address, as well as a description of which part of the process they perform.
- Quality control procedures & checks.
General safety and performance requirements
This document, also called as GSPR, is mandated under Annex 1 of the MDR. 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.
Benefit Risk analysis and Management
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.
The process of identification, understanding, controlling, and prevention of failures that can result in hazards from the use of your device, is called Risk Assessment.
The detailed requirements of the system are listed in Annex I Chapter I, points 2-9. The MDR is in alignment with EN ISO 14971:2016 and EN ISO 13485:2016. The building of a Risk Analysis Plan & Report, in accordance with these two ISO standards, allows you to comply with the MDR and establish the Risk-Benefit analysis.
- Risk management plan.
- Risk management report.
- The risk management plan must be available for each device
- Should be able to identify foreseeable hazards associated with each device
- Should be able to estimate and evaluate the risks
- Should have plans to eliminate/control the risks
- Should be able to assess the impact of risk at various stages of the device’s lifecycle and thereby estimate overall risk, benefit-risk ratio, and risk acceptability.
Product Verification and Validation
This section mentions that the technical documentation shall contain results and critical analyses of all verification and validation tests/studies. Some significant Tests/studies discussed in the section are:
- Electrical Safety
- Electromagnetic compatibility
- Software verification and validation
- Performance and Safety
- Physical, chemical, and microbiological characteristics
Podcast Interview on Product Equivalence
Podcast interview on Sufficient Clinical data
Post-Market Surveillance (PMS)
EU MDR Post Market Surveillance is necessary and an obligation of the manufactures regardless for the medical device’s classification. The conformity assessment processes for acquiring a CE mark, as defined in Annexes IX to XI, require that manufacturers create and maintain a PMS mechanism proportional to the device’s risk class and type, but only the requirements change as per the risk class.
Medical device manufacturers must base their PMS system on a post market surveillance plan (Article 84), which must be included in the technical documentation and must demonstrate compliance with the 2017/745 PMS criteria. Annex III lays out the standards and substance of a PMS strategy, which must address the collection and use of post-market data.
The PMS and Reporting of incidents involving medical devices allow identification of problems with the design, manufacture or use of medical devices and, ultimately, enhances patient safety. The aim of the PMS System is to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire medical device lifetime.
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. It contains the following information:
- name and full business address or that of authorized representative.
- the product’s serial number, model or type identification.
- classification of the Medical Device under the MDR Annex VIII/8.
- a statement, stating full responsibility.
- identification of product allowing traceability – this can include an image.
- details of the notified body which carried out the conformity assessment procedure (if applicable).
- relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance.
- name and signature.
- date the declaration was issued.
- supplementary information (if applicable).
The Declaration of Conformity is a document that you write and which is like your confirmation that you followed all the rules for the compliance of your product. So you should have that ready when your Notified Body is reviewing it. Check Annex IV of the EU MDR to see how it should look like,
New Requirements Regarding Technical documentation/Dossier
Technical Documentation Medical device Templates
To help you I also created some templates for technical documentation and GSPR checklist.
Don’t hesitate to click on the button below to get access to the templates.