Virtual Manufacturer Consulting
New MDR/IVDR regulations make it mandatory to have full technical documentation for all devices and to comply with manufacturer requirements, regardless of whether it is an OBL or OEM manufacturer.
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) |