Module 17 2024

Howard Dobbs

04/12/2024

Why do companies like to produce OBL devices? (cont) • In the past, the regulatory requirements for OBLers were minimal. The OBLer was required to have only a minimal Quality Management System (QMS) and to hold only summary technical documentation. • Today, this is no longer the case, as this presentation will show. • In the future we may see fewer OBL devices as the regulatory requirements become more stringent.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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Definition of Manufacturer MDR Article 2(30)

’manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark • This is the “Original Equipment Manufacturer” • The OBLer is not the OEM • But, as you will see soon, the OBLer must assume the obligations of the OEM

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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