Overview

Laboratories operating within the European Union often review product certifications and regulatory status before implementing new equipment and accessories. One question that occasionally arises concerns the CE marking status of the MICROSOLV Window Maker™ used for preparing detection windows in capillaries.

The Window Maker™ is a specialized laboratory accessory designed for use with Capillary Electrophoresis (CE) capillaries and associated laboratory workflows.

CE Marking Status

The MICROSOLV Window Maker™:

• Is not CE marked.
• Has not recently been evaluated for conformity with current CE marking requirements.
• Has not been recently certified under applicable European CE compliance programs.

As a result, the product should not be represented as CE certified or CE compliant.

Understanding What This Means

A CE mark is used to indicate that a product complies with applicable European Union requirements for products covered by relevant directives or regulations.

Because the Window Maker™ does not carry a CE mark:

• No CE conformity assessment has been completed for the product.
• No CE compliance declaration is provided.
• No CE certification documentation is available.

The absence of a CE mark does not constitute a statement regarding product performance, suitability, reliability, or quality.

Considerations for European Laboratories

Laboratories located within the European Union should evaluate products according to their own:

• Internal purchasing procedures
• Quality requirements
• Risk assessment processes
• Regulatory compliance programs
• Standard operating procedures

Each organization is responsible for determining whether a non-CE marked laboratory accessory is acceptable for its intended use.

Internal Evaluation and Documentation

Organizations that choose to use non-CE marked laboratory accessories may wish to maintain documentation regarding:

• Intended use
• User training
• Operational procedures
• Risk assessments
• Internal approval processes

Requirements will vary depending on the organization and local regulatory environment.

Product Classification Considerations

The Window Maker™ is designed as a specialized laboratory accessory used by trained personnel for creating detection windows in capillaries.

It is not intended to function as:

• A standalone analytical instrument
• A measurement device
• A personal protective device

Users should consult their internal compliance teams regarding any specific regulatory requirements applicable to their organization.

Key Takeaways

• The MICROSOLV Window Maker™ is not CE marked.
• No CE conformity assessment has been performed for the product.
• No CE certification documentation is available.
• European laboratories should evaluate the product according to their own compliance requirements and procedures.
• Product acceptance decisions should be made by the user's organization based on applicable regulations and internal policies.

Additional Resources

For Window Maker™ specifications, capillary preparation guidance, product images, and ordering information, view:  Window Maker™ for CE Capillaries, Detection Window Preparation Tools, Product Images, and Ordering Information