Medical Device
Companies Fear
Parallel Regulation After Brexit Vote
Medical Device companies fear
that Britain’s exit from the European Union could result in a “parallel”
regulatory system which would require them to file separate applications to
access the U.K. and E.U markets, according to a new report from ScienceBusiness.
Only 2 weeks ago, the
Environment, Public Health and Food Safety Committee of the European Parliament
and Council’s Committee of Permanent Representatives voted to endorse new
medical device and in vitro diagnostic regulations.
The approval paves the way for
the adoption of 2 new draft regulations by the end of 2016, though the new rules
would not take effect for 3 years in relation to medical devices and 5 years for
IVD. The regulations cover the design, manufacturing and clinical testing of
medical devices and in vitro diagnostics, and will affect all device
manufacturing and sales in the E.U.
Whether those regulations will
now apply to products in the U.K. is still uncertain, according to the report
from ScienceBusiness.
“From a business perspective it
is hard to see an upside to the UK’s decision to leave the EU. Britain’s
influence in the development of the European MedTech regulatory environment has
been extremely positive and we now face an uncertain situation with possible
regulatory divergence over time,” Cook Medical EMEA exec veep Bill Doherty told
ScienceBusiness.
Currently, medical devices can be
marketed throughout the E.U. with only CE Mark approval by any of the
approximately 70 notified bodies which are overseen by national regulators.
“It’s a question of what they
will be able to rescue from the wreckage. If a deal cannot be done, device
manufacturers would need to go through approval twice, once for the U.K. market
and once for the EU market, and I don’t see any value in that for anyone,” U.K.
Health Research Authority research ethics advisor Hugh Davies told
ScienceBusiness.
Davies said he expects the
country will try to keep things “as harmonised as possible,” which would allow
for the mutual recognition of U.K. and EU notified bodies, with the U.K.
following the previously agreed upon rules and regulations.
“The U.K. MHRA has been
incredibly influential in leading on so many aspects of how healthcare products
are regulated. Now we are marginalized. We may be invited to the table but won’t
have a voice,” Davies told ScienceBusiness.
(Ref:
http://www.massdevice.com/medical-device-companiesfear-parallel-regulation-brexit-vote/)
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