According to the EU Commission Recommendation 2013/473/EU, “subcontractors or suppliers cannot fulfil in the manufacturers’ place, crucial obligations of manufacturers, such as keeping available the full technical documentation”. From 1st September, 2017 all manufacturers will be required to hold full technical documentation for all devices covered by the scope of their certification. This includes Own Brand Labellers (OBLs; soon to be referred to as ‘Virtual Manufacturers’) who currently place devices on the market under their own name.
In addition to obtaining the full technical documentation, virtual manufacturers will need to ensure an appropriate contract is in place with the Own Equipment Manufacturer (OEM). OBLs who have not made the transition to be a Virtual Manufacturer can have their OBL certification suspended for a six month period before cancellation.
Click here to access the MHRA guidance document.
Are you under-resourced? Are you at risk of losing your OBL certification?
Ask a member of the Devices team at Regulis how we can support you through the transition.