The U.S. FDA, has released a list of reusable devices that must provide validation data for the device’s instructions for use (IFUs) and validation data in their 510(k) premarket notifications submissions. Dated Friday June 9, 2017, this list includes devices that have a risk of spreading infection if not cleaned properly and design features on those devices that make… read more
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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… read more
After over 8 years of intense negotiation, the text of the IVD and medical device regulations have been published in the Official Journal of the European Union. UL’s Notified Body comments, “Now the real work begins.” Competent Authorities have 80 implementing and delegated acts to write, 14 of which are mandatory. This adds further detailed… read more