OBL / Virtual Manufacturers

The requirements for OBL manufacturers have changed.  

The EU Commission Recommendation 2013/473/EU requires all manufacturers to hold full technical documentation for all devices covered by the scope of their certification. 

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This means that OBLs will take on the responsibilities of the legal manufacturers, making them Virtual Manufacturers. 

The requirement also impacts existing legal manufacturers whose certificates include devices for which they do not hold full technical documentation. 

The deadline for this change in responsibility is 1 September, 2017. After this time, all manufacturers, including OBLs, will be expected to hold full technical documentation for all devices covered by the scope of their CE certificates.

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.