EU Authorized Representative

The Medical Devices Directive (93/42 EEC), and Ammendments, require foreign manufacturers to utilize an Authorized Representative (established in the EU) as liason between the Competent Authorities, the Manufacturer, and it's Customers. For market Vigilance and timely and access to required information, EU law, Walt Medical LTD is fully qualified to be your Authorized Representative. Engage us to manage your registrations, product filings, and technical files, and provide your Customer Communication and Vigilance. With your name as manufacturer, and ours as AR on your labeling, as required, "Walt Medical LTD" may even enhance your brand.

EU Competent Authority Registrations + CE-Marking

The EU Competent Authorities, the regulatory bodies of the member-states, require manufacturers to comply with EU law prior placing products on the market. Though requirements vary by product type and to some extent by country, the EU is mainly standardized. The MHRA is the UK's distinguished Competent Authority, and Walt Medical LTD is strategically located in Manchester UK and familiar with this distinguished EU regulatory body to promptly and successfully assure your continued compliance.

The CE mark is well known in the EU, the mark that declaring a product complies with essential requirements. For products that require it, though Walt Medical LTD works with many Notified Bodies, by your preference, the Notified Bodies of the UK are distinguised - Walt Medical LTD can highly recommend them.

Let's discuss your needs and engage to provide the expertise and manpower you need to successfully navigate the regulatory landscape and assure timely compliance of your products and business in your target markets.

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