EU MDR - Sunglasses and Labeling Requirements

Question:

If a Made in China sticker is required on sunglasses, but cannot be placed directly on the lens due to quality standards, can a "Made in China" tag be attached to the frame under United States (U.S.) eyewear requirements? And when selling these glasses in the European Union (EU), how does the EU Unique Device Identification (UDI) System impact manufacturer obligations?

Answer: 

U.S. Customs and Border Protection would require either “Frame China” or “Made in China” to be placed in legible English type, printed in permanent contrasting colors on the frame’s temple or temple tip. Given that a removable sticker is allowable, a tag, securely attached to the frame’s temple, should also be allowable.

Corrective glasses and sunglasses fall under the lowest risk class of the EU Medical Device Regulation (MDR), Class I. At this level, self-certification is appropriate. The certification should be created in line with the International Organization for Standardization (ISO) 13485 for EU and U.S. sales, Article 19 of the EU MDR (specifically Annex II and III), and Article 84 and 85 of the EU MDR (which require a defined post-market surveillance strategy). Once certification is completed, it is possible to generate a self-signed approval under EU MDR.

Once completed, this process enables the device to be registered in the updated European Databank on Medical Devices (EUDAMED) system, which is expected to go live later this year. Registering under EUDAMED will generate an EU UDI for the product. While registering, be sure to also apply for CE certification.

Article current as of 2019-08-16.

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