Module 17 2024

Howard Dobbs

04/12/2024

What are OBL devices?

• OBL devices are devices which are CE marked by the OBLer and are placed on the market under the OBLer’s name. • OBL devices have already been CE marked by another manufacturer, usually called the Original Equipment Manufacturer (OEM). • Examples range from adhesive dressings to surgical gloves to contact lenses.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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Why do companies like to produce OBL devices?

• It’s a cheaper and faster way to get a new product to market. • It creates the impression that a device made by a foreign manufacturer is made in the EU or in the UK. • It allows a company to strengthen its product offering and to leverage its sales channels. • It allows a company to access complementary markets and become a one-stop shop for that particular therapeutic segment.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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