Representation | PPE

 Your Authorized Representative for Personal Protective Equipment (PPE)

We offer representation and regulatory compliance for personal protective equipment (PPE), ensuring seamless access to the European market.

Marketing of Personal Protective Equipment in the EU

The deployment of personal protective equipment (PPE) is regulated by Regulation (EU) 2016/425 on PPE. This regulation defines the access of non-EU PPE to the European Union and requires manufacturers like you to designate a European Authorized Representative (EC-REP) to market their solutions.

CMC can act as your PPE authorized representative and serve as the point of contact with the authorities.

Expert regulatory representation services for PPE

Complete the contact form and one of our consultants will get in touch as soon as possible.

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Frequently asked questions about representation services for PPE

To sell PPE in the European Union, products must comply with the Personal Protective Equipment Regulation. This regulation ensures that all PPE meets necessary health, safety, and environmental standards to be marketed within the EU.

The PPE Regulation is under the scope of the Market Surveillance Regulation, which requires manufacturers outside the EU to have an economic operator, such as an authorised representative, based in the EU. This representative ensures that the PPE complies with EU regulations and acts as the contact point for market surveillance authorities.

An authorised representative can assist manufacturers with several compliance-related services, including:
○ Verifying that all documentation complies with the PPE Regulation.
○ Carrying out post-market surveillance activities to ensure ongoing compliance.
○ Keeping manufacturers informed about regulatory changes in the EU.
○ Maintaining and providing access to the Declaration of Conformity and technical documentation for competent authorities.
○ Assisting in finding a notified body that can assess the conformity of PPE.

The Declaration of Conformity is a document that certifies that the PPE meets all relevant requirements of the PPE Regulation. It must be maintained and made available to the competent authorities to demonstrate the product’s compliance.

Manufacturers must ensure their PPE products are tested and assessed by a notified body to verify conformity with the PPE Regulation. This involves evaluating the design, manufacturing, and performance of the PPE to ensure it meets the necessary standards.

Manufacturers must ensure their PPE products are tested and assessed by a notified body to verify conformity with the PPE Regulation. This involves evaluating the design, manufacturing, and performance of the PPE to ensure it meets the necessary standards.

Ensure compliance and market access for personal protective equipment

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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