OBL / Virtual Manufacturer Consulting
How can you market a product as a virtual manufacturer / OBL manufacturer?
European Commission Recommendation 2013/473/EU as well as the new MDR/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) |
How can we help?
Our experts will help your company to meet the requirements of the virtual manufacturer in accordance with current legal requirements.