How can you market a product as a virtual manufacturer / OBL manufacturer?
European Commission Recommendation 2013/473/EU as well as the new MDR and IVDR regulations require all manufacturers to have full technical documentation for all devices of which they are legal manufacturers, making them virtual manufacturers.
|Products not subject to certification by a notified body||Products subject to certification by a notified body|
|– The virtual manufacturer (OBL) shall keep up-to-date the technical documentation and make it available to the competent authority upon request||– The notified body shall audit the virtual manufacturer’s quality management system (OBL)|
|– The virtual manufacturer (OBL) meets the relevant regulatory requirements||– The notified body audits the design, manufacture and quality control process of the actual manufacturer (OEM)|
|– The notified body shall assess the complete technical file held by the virtual manufacturer (OBL)|