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Trusted by +120 global manufacturers

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Trusted by +120 global manufacturers

Trusted by +120 global manufacturers

GLossary

GLossary

Gap Analysis

Gap Analysis

Gap Analysis

A Gap Analysis is a comparative review used to identify the "distance" between your machinery’s current design and the legal requirements of the EU. For North American manufacturers, this is often the first technical step after a Requirements Assessment. While your machine may be perfectly safe and compliant with US standards like NFPA 79 or ANSI B11, it may still fail to meet European Harmonized Standards.

This analysis typically focuses on technical discrepancies rather than just hazard identification. For example, it might reveal that your US-standard wiring colors (white for neutral) violate EN 60204-1 (which requires blue), or that your guarding relies on hazard warnings rather than the "inherently safe design" hierarchy mandated by ISO 12100. It also scrutinizes your documentation, flagging missing translations or inadequate circuit diagrams that would cause your Technical File to be rejected.

Conducting a Gap Analysis early prevents expensive retrofits. By catching issues like non-compliant interlocks or missing EMC Testing data before the machine leaves the factory floor, you ensure a smoother path to signing the Declaration of Conformity (DoC).

Frequently Asked Questions

How is a gap analysis different from a risk assessment?

What EU regulations do I need to comply with?

What EU regulations do I need to comply with?

What EU regulations do I need to comply with?

Can we skip the gap analysis if our machine is UL listed?

What's the biggest compliance mistake companies make in Europe?

What's the biggest compliance mistake companies make in Europe?

What's the biggest compliance mistake companies make in Europe?

At what stage should we perform a gap analysis?

Do I need an EU Authorized Representative?

Do I need an EU Authorized Representative?

Do I need an EU Authorized Representative?

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© 2025 EdgeComply Ltd. “EdgeComply” and the EdgeComply logo are registered trademarks of the company. EdgeComply is a Milio company.
Registered in England & Wales, Company Number 15935592.

EdgeComply empowers brands with expert compliance consulting. We do not provide legal advice or act as a law firm. Clients should consult qualified legal professionals for legal matters.

CE compliance done-for-you.

United Kingdom

2 Appleby Yard

London SE10 0BJ

United Kingdom

United States

101 Cooper St (NextSpace)

Santa Cruz, CA 95060

United States

Germany

Kolonnenstr. 8

10827 Berlin

Germany

We partner with +300 lab testing facilities across all continents.

hello@edgecomply.com

© 2025 EdgeComply Ltd. “EdgeComply” and the EdgeComply logo are registered trademarks of the company. EdgeComply is a Milio company.
Registered in England & Wales, Company Number 15935592.

EdgeComply empowers brands with expert compliance consulting. We do not provide legal advice or act as a law firm. Clients should consult qualified legal professionals for legal matters.

CE compliance done-for-you.

United Kingdom

2 Appleby Yard

London SE10 0BJ

United Kingdom

United States

101 Cooper St (NextSpace)

Santa Cruz, CA 95060

United States

Germany

Kolonnenstr. 8

10827 Berlin

Germany

We partner with +300 lab testing facilities across all continents.

hello@edgecomply.com

© 2025 EdgeComply Ltd. “EdgeComply” and the EdgeComply logo are registered trademarks of the company. EdgeComply is a Milio company.
Registered in England & Wales, Company Number 15935592.

EdgeComply empowers brands with expert compliance consulting. We do not provide legal advice or act as a law firm. Clients should consult qualified legal professionals for legal matters.

CE compliance done-for-you.

United Kingdom

2 Appleby Yard

London SE10 0BJ

United Kingdom

United States

101 Cooper St (NextSpace)

Santa Cruz, CA 95060

United States

Germany

Kolonnenstr. 8

10827 Berlin

Germany

We partner with +300 lab testing facilities across all continents.

hello@edgecomply.com

© 2025 EdgeComply Ltd. “EdgeComply” and the EdgeComply logo are registered trademarks of the company. EdgeComply is a Milio company.
Registered in England & Wales, Company Number 15935592.

EdgeComply empowers brands with expert compliance consulting. We do not provide legal advice or act as a law firm. Clients should consult qualified legal professionals for legal matters.