MHRA have now issued their guidance explaining how Own Brand Labelers (OBL) are now considered Virtual Manufacturers, adding additional requirements in order to receive certification. Under the new guidance and EU Medical and IVD Regulations, in addition to the contractual review required under the current OBL process, manufacturers must have on hand the product's full technical documentation and also undergo a Notified Body audit among other requirements. These changes apply to all device classes.
Special accommodations, including holding redacted design information are also included in the Guidance.
UL is a Notified Body under MHRA and our expert team of in-house regulatory medical staff provides Notified Body services for both OEM and Virtual Manufacturers. Please contact us to learn more about our Notified Body services under the existing European Directives and future Regulations.
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