Color contact lenses or “eye lenses” sold in the EU/EEA must comply with the EU Medical Devices Regulation (EU) 2017/745, aka “MDR”, just like corrective lenses. Even purely cosmetic or non-prescription lenses (e.g. plain or color lenses) fall within scope under Annex XVI, meaning CE‑marking, product safety requirements, and regulatory oversight all apply. (To read more: Visit official website). Here’s a summary of what EU importers and sellers need to know:
1. Regulatory Scope & Legal Status 🧐
- The MDR (Regulation (EU) 2017/745) defines contact lenses—including color, circle, or decorative types—as medical devices.
- Annex XVI of MDR explicitly includes “colored contact lenses” even when worn for cosmetic/aesthetic purposes—so they must still comply with CE‑marking and technical documentation requirements.
2. Device Classification & Risk Class 🚦
According to MDR Annex VIII & MDCG guidance (2024 version)
- Class IIa: Non-corrective aesthetic lenses (e.g. plain color or printed patterns) intended for short-term use (daily or ≤ 1 month).
- Class IIb: Non-corrective lenses intended for long-term or extended wear, including decorative variants worn > 30 days.
- Corrective color lenses (e.g. plano tinted or impaired vision) are treated as dual-purpose devices and must meet higher medical-device standards.
(ECOO guidance also affirms IIa classification for short-term lenses ≤ 30 days).
3. Conformity Assessment, CE Mark & Notified Body ✅
- Class IIa/IIb lenses require review and CE certification by an accredited notified body—self‑certification is not permitted.
- You must maintain a Technical Documentation File (TDF), including safety and performance data, labeling, stability/clinical evidence, and post-market procedures.
- The manufacturing facility must operate under a Quality Management System (QMS) (e.g. ISO 13485 or equivalent).
4. UDI & Eudamed Requirements 🔎
- MDR mandates a Unique Device Identifier (UDI‑DI) system for all devices. For contact lenses, the EU has introduced a special “Master UDI‑DI” scheme per Delegated Regulation (EU) 2023/2197 (applicable from 9 Nov 2025).
- This UDI must be encoded in EUDAMED, the EU’s central database, and printed on packaging (though not necessarily each blister if exempt).
- Contact lenses are flagged as “highly individualised devices,” so the UDI scheme groups similar models with a Master UDI‑DI and individual PI/Lot-level identifiers.
5. Labeling & Prescription Sale Requirements 🧴
- Even purely cosmetic lenses must be sold with a valid prescription provided by a qualified professional (optometrist, ophthalmologist or equivalent). Self-fit or OTC sale is strictly prohibited.
- Labels must include:
– CE Mark and Notified Body reference.
– Product identifier and lot code or serial number (UDI‑PI).
– Intended use, expiry date, sterility statement, storage conditions, warnings, instructions - Patient information leaflet: must cover hygiene rules, warnings (e.g. no overnight wear), risks, and instructions for use.
6. Post-Market Surveillance & Vigilance Monitoring 📝
- Manufacturers and importers must report serious incidents and field safety corrective actions into EUDAMED.
- The MDCG 2024‑14 guidance ensures traceability for lens batches during recalls and incident investigations
7. Important Deadlines & Transition Timing 🗓
- MDR fully replaced MDD/AIMDD on 26 May 2021. Under transitional rules, MDD-certified lenses may remain on the market only until the expiry date of their certificate.
- The Master UDI‑DI requirement becomes mandatory on 9 November 2025, per Regulation 2023/2197. Until then, lenses may continue under MDD identifiers, but voluntary use is encouraged.
| Requirement | Details |
|---|---|
| Legal basis | MDR 2017/745 + Annex XVI recognizes color or cosmetic lenses as devices |
| Risk Class | Class IIa (≤30 days use), Class IIb (>30 days use) |
| CE Certification | Required via Notified Body for IIa/IIb types |
| Quality & Documentation | ISO 13485 compliant QMS, Technical File, Clinical/biocompatibility data |
| UDI & EUDAMED Registration | Master UDI-DI from Nov 2025; previous & newer models must be traceable |
| Prescription & Labeling | Eye care professional prescription, CE mark, instructions, warnings |
| Vigilance / Post-market | Mandatory serious incident reporting & field safety corrective actions |
| Transition timeline | MDD -> MDR since May 2021; MDD CE valid until expiry; UDI mandatory by Nov 2025 |
Note: These findings are based on my personal research and analysis. For full and official guidance, please consult the EU Medical Devices Regulation on the official EU websites. If you have questions, feedback, or notice anything that needs amending, feel free to email me at info@skinkrbeauty.com