Product and legislation review
Identify the product, intended use and relevant European requirements.
CE MARKING — READINESS & GUIDANCE
Define the model and intended use.
Identify gaps in technical records.
UNDERSTAND THE ASSESSMENT
CE marking applies only where the relevant European product legislation requires it. The manufacturer must identify the requirements, follow the appropriate conformity route and prepare the required evidence. We help organise the readiness discussion and documentation scope; we do not replace a notified body where one is required or take over the manufacturer’s legal responsibility.
PLAN THE RIGHT SUPPORT
Identify the product, intended use and relevant European requirements.
Organise the evidence, specifications and risk-related records for review.
Determine whether the applicable route allows self-assessment or requires notified-body involvement.
Review the records needed before the responsible manufacturer signs and affixes the marking.
Start with the actual model and intended use.
Identify gaps in the technical record before making compliance claims.
Separate advisory support from the legally required conformity assessment.
The correct route depends on the people, activity and location involved.
Check whether CE-marking legislation covers the product.
Identify the manufacturer and other relevant economic operators.
Review the applicable assessment requirements and any notified-body role.
Confirm the current framework, competent assessment body and scope for the particular case.
Choose the structure around your ownership and operating plans.
This is a starting checklist. Final requirements depend on your profile and the relevant filing procedure. Do not submit identity documents through the general enquiry form.
Confirm models, intended use and target market.
Stage 1
Identify the relevant legislation and assessment route.
Stage 2
Review technical documentation and any testing or specialist assessment needs.
Stage 3
The manufacturer completes the required conformity process before declaration and marking.
Stage 4
Depends on the completeness of the design and evidence record.
Required laboratory or notified-body work has its own schedule.
The required conformity steps must be completed before the product is placed on the market.
UNDERSTAND THE DIFFERENCE
| Element | Role | Important distinction |
|---|---|---|
| Technical documentation | Supports assessment of product conformity. | Must relate to the actual product and requirements. |
| Notified-body involvement | Performs the specified independent assessment where required. | Not required for every product and not replaced by a voluntary certificate. |
| EU declaration of conformity | Records the responsible declaration under the applicable law. | Does not transfer the manufacturer’s responsibility to an adviser. |
Trade Innovation does not claim notified-body status or authority to issue a universal CE certificate. Voluntary certificates do not replace legally required conformity assessment.
WHY TRADE INNOVATION
Start with your plans and available records. We’ll help organise the work into an understandable scope.
Identify the documents needed for the agreed route.
Know what information and decisions are needed from you.
Separate initial setup from continuing compliance and other licences.
CLIENT EXPERIENCES
Preview content: cards marked “Design sample” use fictional names, feedback, ratings and dates.
VIDEO GUIDES
EXPLORE OTHER BUSINESS OPTIONS
Get help with your IEC application, supporting documents and the details your business needs to keep up to date.
Explore service
Review your proposed products, activity and premises to organise the application requirements relevant to drug or cosmetic operations.
Explore service
Review the activity, site and operating stage to identify the consent, authorisation or clearance requirements relevant to your project.
Explore serviceNo. Check whether the relevant European legislation covers the specific product.
No. The applicable legislation and conformity procedure determine whether independent notified-body involvement is required.
A voluntary certificate alone is not a substitute for the required assessment, technical documentation and declaration.
The manufacturer remains legally responsible for the product’s conformity and the required declaration.
No. Product conformity and other applicable market requirements must be satisfied; advisory support is not an approval guarantee.