The real CE marking technical documentation set we deliver: a complete CE Technical File to place a product on the EU market, in 70 editable documents. It carries a 46-section Technical File covering the product description, bill of materials, drawings, harmonised standards, essential safety requirements, risk analysis, validation and test reports, labels, instructions for use and the Declaration of Conformity, with a cover selector for the applicable EU directives, plus 21 supporting forms and two sample EU Declarations of Conformity. It includes the regulated and sterile-product depth a medical device needs, and you keep the sections that apply to your product, so you can build your CE technical file without hiring a consultant.
Preparing the documentation is the slowest and most confusing part of getting certified to CE Marking. You have to work out what the standard asks for, decide what to write, and turn it into a manual, procedures and records that an auditor will accept. Done from a blank page it takes months, and paying a consultant to do it can cost thousands.
The CE Marking Documentation Toolkit gives you that whole system, already written and ready to edit. It is built by practitioners around the exact structure of the standard, so nothing an auditor expects is missing. You add your company details, adapt anything specific to your operation, and you have a complete, consistent product ce marking system that is ready for audit. Every single document you receive is listed and explained further down this page, so you know precisely what you are buying before you spend anything.
A 46-section technical file covering everything a CE technical documentation set needs: product description, bill of materials, drawings, harmonised standards, essential safety requirements, risk analysis, validation and test reports, labels, instructions and the Declaration of Conformity.
The cover carries a directive selector listing the main EU directives and regulations, from the Machinery, Low Voltage, EMC and Medical Device directives to PPE, RoHS, ATEX, Radio Equipment and Construction Products, so you mark the ones that apply to your product.
Beyond the universal sections, it includes the depth a regulated or sterile product needs, such as controlled environment, batch records, stability, post-market surveillance, cleaning, sealing and ETO sterilization validation, and bio-burden and sterility reports.
A procedure for CE marking and two sample EU Declarations of Conformity, so the final self-declaration that lets you affix the CE mark is ready to complete.
Twenty-one supporting forms across system, production, engineering, quality control, service, design and stores, so the records behind the technical file are captured.
An index flags which chapters apply to which product type, so you keep, remove or complete each section for your product and its directives before you place it on the market.
Each tier answers a different question and is approved at a different level, and every requirement is owned in exactly one place.
No hidden contents and no vague claims. Here is the complete document set, with a short description of what each file is for and the clause it helps you meet.
A complete document set, fully editable in Microsoft Office.
The cover and index of the CE technical documentation. It carries the directive selector, listing the EU directives and regulations you can apply to your product, and the index of the 46 technical file sections. It is the entry point to the technical file that demonstrates your product meets the essential requirements of the applicable directives.
The writing is done. You edit instead of authoring from a blank page.
Get a professional system for a fraction of the cost of hiring one.
Mapped clause by clause so every requirement is covered.
Easy to read, easy to adapt, no jargon you have to decode.
Forms and registers capture exactly what an auditor asks to see.
A perpetual licence for your whole team, with free updates.
The full set arrives by email in minutes, in Word and Excel.
Swap the highlighted placeholders for your own company details.
Roll out the procedures and capture evidence on the forms.
Use the internal audit checklist and management review templates.
Face the auditor with a complete, consistent system.
Files sent securely within 24 working hours of payment.
Microsoft Word and Excel, with placeholders to fill in.
If the standard is revised, you get the update free.
One organisation, unlimited internal users, perpetual.
| What matters | From scratch | Hire a consultant | isofolder kit |
|---|---|---|---|
| Time to a full document set | Months | Weeks | The same day |
| Typical cost | Your time | Thousands | $149 once |
| Written by experts | No | Yes | Yes |
| Mapped to every clause | Risky | Usually | Yes |
| You keep full control | Yes | Limited | Yes, fully editable |
| Free updates on revision | No | Extra fee | Included |
isofolder is a team of auditing and consulting professionals with more than 80 years of combined experience. Our kits are written by practitioners and reviewed by working auditors, then refined across many real certification projects. When you buy from us, you are buying a system that has already helped companies pass their audits.
If you ever need a document that is specific to your operation and not already in the kit, our team will prepare it for you.
The documents were well structured and easy to adapt. We cleared our certification audit with no major findings.
Saved us weeks of writing. Everything was mapped to the clauses, so we knew nothing was missing.
Clear, professional and fully editable. Far better value than the consultant quotes we received.
Preview 10 real pages from the CE Marking toolkit right here, including a full form and part of an actual procedure. Judge the quality and writing style for yourself, with no sign-up.
Download the complete, editable toolkit and start building an audit ready system in minutes, with a free sample available before you buy.