TRTürkçe
ENEnglish
AZAzərbaycanca
UZO‘zbekcha
ARالعربية
FRFrançais
DEDeutsch
RUРусский
CE Compliance for Masks and Protective Coveralls
The intended purpose determines the route: a product protecting the wearer is PPE, one serving a medical purpose may be a medical device, and a dual-purpose product must be assessed against both regimes.
Direct answer
Do not select tests or a conformity body before confirming the protection claim, risk category, material/sterility, single or reusable design and applicable standards. A notified-body number accompanies CE only when required by the legislation.
How is the scope determined?
A product name alone does not determine the legislation. The intended use, technical characteristics, target market, whether the item is a component or a complete system, and any connected functions must be confirmed first.
Evidence to prepare
How is the scope determined?
- Regulation (EU) 2016/425 — PPE
- Regulation (EU) 2017/745 — medical devices where applicable
- single, dual and medical intended purpose
Evidence to prepare
- product and model identity with intended use
- matrix of applicable legislation and standards
- risk assessment, test plan and test reports
- labelling, instructions and declaration of conformity
- production-control and traceability records
Common mistakes
- treating CE marking as a third-party quality certificate for every product
- using one test report without addressing product-family and model differences
- presenting CE marking, type approval, operating permits and market registration as the same process
Implementation route
- Define the product function, user and target market in writing.
- Separate applicable EU product legislation from non-CE approval routes.
- Identify standards, risks and test gaps for each model.
- Align the technical file, labelling and declaration to one confirmed scope.
- Control design changes and traceability after placing the product on the market.
Related guides
Frequently asked questions
Is a notified body required for every product?
No. Third-party involvement is required only where the applicable legislation and conformity-assessment procedure demand it; the notified scope should be checked in NANDO.
Does Kayra Patent issue CE marking or type approval?
No. Kayra supports scope analysis, file preparation and coordination. The final decision belongs to the competent authority, technical service, laboratory or notified body.
How are time and cost established?
They depend on model count, risk, testing, available evidence, sites, target market and external-body schedules. A fixed promise before scope review would be misleading.