Is there any specific time line to update the labels for the *Class* *I* and *Ir* devices. - Medical Devices Group

« Back to Previous Page

mahamad shafi S S

RA

August 2019

Is there any specific time line to update the labels for the *Class* *I* and *Ir* devices.

< 1 min reading time

Is there any specific time line to update the labels including the UDI/human readable requirements for the *Class* *I* and *Ir* devices.

Marked as spam

Posted by S S

Asked on August 8, 2019 10:21 pm

136 views

	Private answer mahamad shafi S S Hi, anybody could answer me please Marked as spam Report spam
	Private answer Michelle Lott, RAC Hi Mahamad Unfortunately Class I and Ir both have to be fully compliant to the MDR by May 26, 2020. There are to "rubs" here: 1) you can comply with UDI if the EU commission doesn't have their ducks in a row with the database. 2) 1r involves a notified body involvement. As you know they're are only two designated at the moment and a hard brexit could leave us with just one. Supposedly the EU will designated 20 more by the end of 2019 but who knows?! It took them 24 months to designated the two they have. There may not be enough that can do the work by May! Raimund Laqua at www.eudamed.eu will be able to look in the crystal ball and answer your UDI questions a bit better. (That website is his own business because the EU did so little planning for Eudamed they did not even buy the domain. Tell him Michelle sent you.) Marked as spam Report spam
	Private answer mahamad shafi S S Thanks Michelle Marked as spam Report spam

« Back to Previous Page