CE marking (MDR) – medical devices, safety, and documentation
CE marking (MDR) – Medical Devices, Safety, and Documentation
At 444 Studios we work systematically to comply with applicable EU legislation. Selected products are classified as medical devices and CE marked according to EU Medical Device Regulation (MDR 2017/745).
CE marking according to EU MDR
What does CE marking mean under MDR?
The CE mark shows that the product has been assessed against safety requirements, performance, risk management, and technical documentation.
- Risk assessment
- Technical documentation
- Declaration of Conformity
- Traceability (batch/lot where relevant)
- User manual
CE marking is the manufacturer’s legal declaration of conformity with applicable EU legislation.
Incontinence products and MDR
Selected products for managing urinary incontinence may be classified as medical devices and is therefore regulated under MDR 2017/745.
This ensures documented safety, correct labeling, and traceability before marketing in the EU.
The 444med brand
Some CE marked products are marketed under the brand 444med, developed in collaboration between 444 Studios and Levabo.
Documentation
- User manual (available for download on the product page)
- Product information
- EU Declaration of Conformity (upon request)
Frequently Asked Questions
Are all products CE marked?
No. Only where clearly stated on the product page.
What does CE mean under MDR?
That the product complies with the EU requirements for medical devices.
Where can documentation be found?
User manual available on the product page. Other documentation can be provided upon request.
Contact
444 Studios
kontakt@444studios.com
This page contains general information about CE marking and applies only to products classified as medical device under MDR.