Originally Published MDDI January 2002
NEWS & ANALYSIS
Deferring the EU Agreement Two More YearsIn a disappointing
blow to industry, FDA and European regulators have extended the medical device
annex of the U.S./EU mutual recognition agreement (MRA) transition period for
two years. Once operational, the MRA will allow conformity assessment bodies
(CABs) to conduct low-risk medical device reviews and quality systems–based
inspections on behalf of the regulators.
"It is very disappointing that the MRA is not moving into an operational
mode," National Electrical Manufacturers Association medical vice president
Bob Britain commented.
The original three-year transition period was seen as a "confidence building"
period after the MRA became effective on December 1, 1998. Both sides were to
complete their verification of CABs that are to conduct low-risk medical device
reviews and quality systems–based inspections on behalf of the regulators.
So far, Britain said no CABs have been verified or "listed"; however,
FDA indicated recently that four CABs may be listed early in 2002.
Britain says industry needs to step up its assistance in getting the CABs approved.
In addition, before the MRA can become operational, the regulators need to agree
on how many CABs should be listed. At this time, he says, both sides have not
come to agreement on the minimum number of CABs needed to allow the MRA to proceed.
Once verified, FDA has suggested that the CABs could be allowed to begin performing
independent 510(k) reviews and inspections—although the MRA won’t
become fully operational until both sides have approved CABs. However, many
are skeptical that the MRA will ever come to fruition; they cite European preoccupation
with a review of the European Medical Devices Directive and say the MRA with
the U.S. doesn't have high priority.
James Dickinson
Copyright ©2002 Medical Device & Diagnostic Industry
