Notified Body Codes: EU Commission Needs To Act Fast
New codes that indicate the scope of notified bodies under the new EU regulations are nearly ready. Will the first implementing act be out on November 26?
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While there has been no official public reaction to the first draft implementing acts linked to the new EU Medical Device and IVD Regulations, background discussion points to considerable anger and frustration – in particular, with a document that sets out codes for notified body designation for IVD oversight.
So, you think you have nearly three years to comply with the EU's Medical Device Regulation and five years with the IVD Regulation. Not so. The clock has started ticking and industry has reason to be concerned.
If there is a delay in appointing EU notified bodies under the new Medical Device and IVD Regulations, it will impact the whole sector's ability to comply in time. But nothing is quite ready.