What a medical device technical file contains and what a buyer may ask to see
The technical file is the manufacturer's evidence that a device is safe and works. A buyer will rarely see all of it, but should know which parts to ask for and why.
What is in a medical device technical file and what can a buyer see?
A medical device technical file holds the device description, labelling and instructions for use, design and manufacturing information, the risk management file, verification and validation reports, the clinical evaluation and the post-market plan. A buyer rarely sees the whole file, but can ask for the declaration of conformity, certificates, labelling, and summaries of the key test evidence.
Ask a device supplier for the technical file and the answer is often a pause, followed by a short pack of certificates and a brochure. That pack may be all you need, or it may leave out the one document your regulator will ask for. Knowing what a technical file is, who it is written for and which parts a buyer can reasonably expect to see makes that conversation much shorter.
This article describes general practice for medical devices and single use consumables. What a technical file must contain in detail, and how it is assessed, is set by the regulation of each market and by the risk class of the device. Check the current requirements for your own market and product type before relying on any summary, including this one.
What does a medical device technical file contain?
The technical file, called technical documentation in some frameworks and a design dossier or design history file in others, is the manufacturer's evidence that a device is safe and performs as intended. It is a living set of records, kept by the manufacturer and updated as the device, its standards and its market experience change. The headings vary between regulators, but the content is broadly the same.
Description and specification
The file opens by saying what the device is: its intended purpose, the patients and users it is meant for, its principle of operation, its variants and accessories, and the materials that touch the patient. A clear description matters because every later section is judged against it. A test report on a different variant, or a claim the description does not support, is a gap.
Labelling and instructions for use
The labels on the device and its packaging, and the instructions for use, are part of the file. They must match the intended purpose, carry the warnings the risk analysis calls for, and appear in the languages the destination market requires.
Design and manufacturing information
This section describes how the device was designed and how it is made, including the manufacturing sites, the critical suppliers and the controls applied during production. It is usually the most commercially sensitive part of the file.
Safety, risk and performance evidence
Here the manufacturer lists the safety and performance requirements that apply, the standards used to meet them and where the proof sits. The risk management file identifies hazards and shows how each one was reduced. Verification and validation reports follow: bench testing, biocompatibility, electrical safety and software validation where relevant, sterilisation validation for sterile products, and packaging and shelf life studies. A clinical evaluation then brings together the clinical data that supports the device's claims.
Post-market surveillance
Finally, the file sets out how the manufacturer collects and acts on information once the device is in use: complaints, field feedback, trend reviews and corrective actions. A file without a working post-market plan is incomplete, however good its test reports.
Why will a manufacturer not send the whole file?
The technical file is written for regulators and, where one is involved, for the conformity assessment body that reviews it. It contains drawings, process details, supplier names and test methods that a manufacturer treats as confidential. Refusing to send the full file to a buyer is normal and is not, on its own, a warning sign. Refusing to send anything at all, or offering only a brochure, is different.
You do not need the whole technical file. You need the parts that prove the device you are buying is the device that was assessed. That means the same model, the same manufacturer and the same manufacturing site on every document you receive.
What can a buyer reasonably ask to see?
A reasonable request, which most serious manufacturers can meet without breaching confidentiality, covers the following:
- the declaration of conformity for the markets the manufacturer claims, naming the device and its models;
- any certificate issued by a conformity assessment body, with its scope, its validity and the sites it covers;
- the quality management system certificate for the manufacturing site;
- the labels and instructions for use, in the version that will ship;
- a list of the standards applied, with their editions;
- summaries or certificates of the key test reports, such as biocompatibility, sterilisation validation and shelf life;
- where your registration needs it, a summary of the clinical evaluation.
If your own regulator needs more than this to register the product, the usual route is for the manufacturer to submit it directly, or to release it under a confidentiality agreement to the party handling the registration. Agree that route before you order, not after the goods have shipped.
How does the technical file relate to registration in your market?
Approval in one market does not register a device in another. The importing country's regulator usually wants its own application, and much of the evidence in that application comes from the technical file. A manufacturer who cannot release the right extracts to the right party can stop a registration, however compliant the device itself may be. Our separate article on SFDA medical device registration covers one market's process in more detail.
Does a simple consumable need a technical file too?
Yes. A low risk consumable such as a dressing, a syringe or an examination glove still needs technical documentation, even where the manufacturer can declare conformity without an outside body reviewing it. The file may be shorter, but the same logic applies: a description, labelling, risk management, the standards applied and the test evidence behind each claim. For sterile items, the sterilisation validation and the packaging studies carry most of the weight. A low risk class lowers the level of outside scrutiny. It does not lower the need for evidence, and a buyer can ask for the same summaries.
What are the warning signs in what a supplier sends?
A few patterns are worth stopping for. Documents that name a different manufacturer or a different site from the one on the certificate. Test reports for a model that is not the one quoted. A certificate whose scope does not include the device category you are buying, or whose validity has lapsed. A declaration of conformity that names no models at all. And a supplier who promises the documents after payment. A trading company may hold some of these papers on the manufacturer's behalf, but it should be able to say whose they are and obtain the rest.
For what each regulatory mark does and does not mean, see CE, FDA and SFDA explained. For telling a manufacturer from an intermediary, see manufacturer or trading company, and for the equipment itself, medical equipment.
NJMC Medical Supplies Co., Ltd is a trading and consultancy company in Nanjing, China, supplying medical equipment, medical consumables and active pharmaceutical ingredients to healthcare institutions, sourced from manufacturers in China and India.
Frequently asked questions
Is a technical file the same as a declaration of conformity?
No. The technical file is the body of evidence a manufacturer keeps to show that a device is safe and performs as intended. The declaration of conformity is a short signed statement, based on that evidence, that the device meets the requirements of a given market. A buyer can usually obtain the declaration, while the full file stays with the manufacturer.
Can a trading company provide the technical file?
A trading company does not own the technical file; the manufacturer does. A capable trader can obtain the declaration of conformity, certificates, labelling and test summaries from the manufacturer, and can arrange for fuller extracts to reach the party handling registration. A trader who cannot say which manufacturer and site the documents belong to cannot support a registration.
What should match across the documents a supplier sends?
The device name and models, the manufacturer's legal name and the manufacturing site should be the same on the declaration of conformity, the certificates, the labels and the test reports. A certificate should also cover the device category in its scope and still be valid. Any mismatch is worth resolving before the order is placed.
Does a CE mark mean the technical file has been reviewed?
Not always. For higher risk devices, a conformity assessment body reviews the technical documentation before the mark is applied. For lower risk devices, the manufacturer can declare conformity itself, so no outside body may have read the file. Ask which route was used and, where a body was involved, for its certificate.
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