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When it comes to medical devices, cosmetics, or chemical products in Europe, compliance with regulatory standards is crucial. Three key certifications often encountered are Swissmedic, CE Marking, and REACH Testing. Here’s a breakdown of what they mean and why they matter.

Swissmedic Certification (Swiss Agency for Therapeutic Products)

Swissmedic is Switzerland’s regulatory authority for medicines and medical devices. While Switzerland is not part of the EU, it aligns closely with European regulations.

• Purpose: Ensures the safety, efficacy, and quality of medical products.

• Applicability: Required for pharmaceuticals, medical devices, and in-vitro diagnostics sold in Switzerland.

• Key Requirements:

  • Compliance with Swiss Medical Devices Ordinance (MedDO)

  • Technical documentation and clinical evaluations

  • Post-market surveillance

CE Marking (Conformité Européenne)

CE Marking indicates that a product meets EU health, safety, and environmental standards. It is mandatory for many products sold in the European Economic Area (EEA).

• Purpose: Allows free movement of goods within the EU market.

• Applicability: Medical devices, machinery, electronics, toys, and more.

• Key Requirements:

  • Compliance with relevant EU directives (e.g., MDR for medical devices)

  • Risk assessment and conformity assessment procedure

  • Technical documentation and Declaration of Conformity

REACH Testing Registration, Evaluation, Authorization, and Restriction of Chemicals

REACH is an EU regulation that ensures the safe use of chemicals in products.

• Purpose: Protects human health and the environment from hazardous chemicals.

• Applicability: Applies to all chemical substances in products, including cosmetics, textiles, and electronics.

• Key Requirements:

  • Registration of substances with the European Chemicals Agency (ECHA)

  • Testing for hazardous properties

  • Compliance with restricted substance lists (SVHCs)