EU Conformity
CE Marking for Menstrual Cups
EU MDR Technical File Support
CE marking for cups — EU conformity evidence for OEM brands
ISO 13485 • Medical-grade silicone • IFU & labeling coordination
Conformity Framework
CE Certification Overview
CE marking for menstrual cups confirms EU MDR conformity before reusable cups and discs reach European buyers — Class IIa assessment via notified-body review, technical documentation, and EU Declaration of Conformity before labeling and IFU release. Furuize supplies the manufacturing and technical-file evidence OEM importers need to complete market authorization.
- • Annex I GSPR compliance with ISO 14971 risk management
- • Clinical evaluation and post-market surveillance readiness
- • UDI pathway for EUDAMED and controlled variant supplements
- • Furuize: manufacture, technical file maintenance, batch release
- • EU brand owner: importer registration, AR, market-language IFU
Annex I GSPR
EU MDR Safety & Performance Requirements
Biological safety
Medical-grade LSR demonstrates biocompatibility through ISO 10993 testing matrices — extractables/leachables screening supports pigment and catalyst choices.
Mechanical integrity
Rim roundness, wall thickness uniformity, stem pull strength, and suction seal behavior validated on cured plaques and finished cups.
Microbial & reprocessing
Non-sterile reusable devices ship with validated cleaning and disinfection instructions — boil-time and sterilizer claims require supporting rationale.
Usability & labeling
IEC 62366 usability engineering reduces use-error risk; MDR labeling rules demand UDI carrier formats and language availability per member states.
Post-market surveillance
Class IIa manufacturers maintain PMS plans capturing complaint trends, serious incident triage, and periodic safety update report cadence.
Annex II Evidence
Technical File & Testing Procedures
MDR Annex II and Annex III define the technical documentation notified bodies examine. Furuize structures each OEM SKU as a controlled technical file index linking design inputs, verification outputs, and post-market hooks.
Technical File Structure
Annex II evidence indexed per OEM SKU
Device Description & Specification
Intended purpose, user population, contraindications, variants (size A/B, stem length, color), and essential performance parameters. CAD-controlled drawings, DMR cross-reference, and packaging BOM show what ships to the EU market matches what was assessed.
Design & Manufacturing Information
Process flow from LSR dosing through demolding, trimming, cleanroom finishing, and kitting. Critical process parameters, environmental monitoring summaries, and sterilization-of-manufacturing-environment rationale where applicable.
Verification & Validation Testing
Biocompatibility reports per ISO 10993 plan, mechanical bench data, shelf-life/reprocessing validation. SGS or accredited-lab certificates indexed by report number and sample lot.
Clinical Evaluation & Benefit–Risk
Clinical evaluation report (CER) synthesizing literature, equivalence arguments, and post-market data for established cup geometries. Benefit–risk conclusion must be explicit for first-time EU entrants.
Risk Management File
ISO 14971 risk analysis covering chemical, thermal, mechanical, and informational hazards through FMEA-linked control measures. Residual risk disclosure in IFU aligns with risk-control verification evidence.
PMS, PMCF & Vigilance Plan
Post-market surveillance procedures, complaint coding taxonomy, periodic report templates, and PMCF activity description. Defines data OEM importers must feed back for PSUR updates.
Go-to-Market
EU Market Access Strategy
Authorized representative setup
EU AR required on labeling for non-EU manufacturers — importer registers in EUDAMED and verifies UDI-DI assignment before first shipment.
Labeling & IFU planning
Member-state language requirements drive IFU translation budget; symbols per ISO 15223; UDI carrier on unit and shelf carton per EU MDR Annex VI.
Channel entry sequencing
Pharmacy and drugstore chains audit technical files deeper than marketplace sellers — sequence launch by obtaining notified-body certificate and AR appointment first.
Private label scaling
OEM programs add sizes, colors, and disc line extensions through technical-file supplements rather than restarting conformity from zero when mold families share material and risk profiles.
Evidence reuse across regions
Biocompatibility and mechanical reports structured for MDR Annex II often support FDA general-controls dossiers and UKCA submissions with regional cover sheets.
CE Marking & EU MDR FAQ
What is CE marking for menstrual cups?
CE marking for cups shows EU MDR conformity before a reusable menstrual cup or disc is placed on the European market — technical documentation, risk management, notified-body review where required, and an EU Declaration of Conformity tied to labeling and IFU.
Are Furuize menstrual cups CE marked for the EU?
Manufacturing evidence supports EU MDR Class I reusable device technical files — conformity assessment and importer duties remain with your EU commercial partner.
What is included in a CE technical file?
Device description, risk management, verification & validation testing, clinical evaluation summary, and PMS plan — coordinated with multilingual IFU.
How does CE relate to ISO 13485?
ISO 13485 is the factory QMS; CE documentation packages that QMS output for European market authorization.
Can you support pharmacy and retail EU listings?
Yes — labeling, UDI placeholders, and test summaries for Boots/DM-style gates. See vendor compliance guide.
Related Compliance & OEM Resources
Certifications & Testing
Manufacturing & Launch
CE Certified Menstrual Cups Ready for Your Brand
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