Compliance of Spectacle Frames with EU Medical Device Regulations

Spectacle Frames as Medical Devices

Spectacle frames are classified as Class I medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR). This regulation, which became fully applicable across the European Union on 26 May 2021, establishes uniform requirements for the safety, performance, labelling, and documentation of medical devices placed on the EU market.

To ensure compliance with MDR, manufacturers must carry out a conformity assessment, prepare the required technical documentation, and issue a CE Declaration of Conformity. Only products that meet these criteria may be lawfully marketed in the EU.

Scorpion Eyewear’s Production and Documentation

As a manufacturer of Scorpion Eyewear branded spectacle frames, we hold complete and up-to-date documentation in compliance with all applicable legal requirements. This documentation may be necessary for optical store owners both when considering a partnership with Scorpion Eyewear and during official inspections or customer inquiries at the point of sale.

The full set of documents is available for download at the end of this article.

Please read on before downloading.

Medical Device Certification – Legal Framework

The certification of spectacle frames as medical devices has gained importance in light of the evolving European regulatory environment. Although Scorpion Eyewear has been registering its medical devices with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) since 2004, the introduction of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) marked a significant shift in the legal landscape across the European Union.

This regulation, fully applicable from 26 May 2021, redefined the classification rules, documentation standards, and conformity assessment procedures for medical devices, including Class I devices such as spectacle frames. It imposed stricter obligations on manufacturers, importers, and distributors operating within the EU.

In Poland, these EU requirements were transposed into national law through the Act of 7 April 2022 on Medical Devices (Polish national legislation: Journal of Laws 2022, item 974), which provided the local legal framework for the implementation and enforcement of MDR provisions.

Understanding and complying with these EU-wide regulations is essential for optical retailers who offer medical devices, ensuring lawful market access and protection for both businesses and end users.

Our Responsibility as a Manufacturer

At Scorpion Eyewear, we take full responsibility for the entire production process – from design and manufacturing to product labelling and preparation of legal documentation. Our frames are developed to meet all regulatory and formal requirements, while also adhering to the highest standards of quality, usability, and aesthetics.

All spectacle frames under the Scorpion Eyewear brand are classified as Class I medical devices and comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR), as well as with the Act of 7 April 2022 on Medical Devices (Journal of Laws 2022, item 974 – Polish national legislation). Compliance is confirmed through the CE Declaration of Conformity and supporting documentation in line with relevant ISO standards.

We hereby confirm that every medical device we sell is provided with:

- appropriate CE marking,

- a valid Declaration of Conformity,

- full technical and legal documentation.

DOWNLOAD DECLARATION OF CONFIRMITY CE