Quality Standards

Manufacturers of Class I (sterile), IIa, IIb and III medical devices must obtain certification demonstrating compliance with the EU directive, 93/42/EEC, from a registered notified body before using the CE mark and placing medical devices on the market.

Mercian instruments and medical devices conform to the essential requirements of the EU Medical Directive 93/42/EEC regarding medical devices, allowing us legally to place the CE mark on our products. We are annually audited by our respected notified body SGS 0120 to ensure compliance with the applicable standards and directive.

We are registered and regulated by our UK Competent Authority; the MHRA as a manufacturer of medical devices.

We also operate a full quality management system which is audited to meet international standard ISO 13485 the world’s most widely recognised quality management system standard for medical devices, allowing us to continually monitor and manage our company procedures and quality across all our operations.

View our quality certificates

ISO 13485:2016 93/42 EEC Annex V

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