 CE
Marking & Authorised Representation
Manufacturers/distributors of CE marked
products based outside of the European Union are required
to appoint an Authorised Representative based within the EU.
The Authorised Representative has the responsibility to represent
the manufacturer/distributor with regard to all legal and
regulatory matters.
Lawrence-Hall
have
substantial
experience
of
acting
in
this
role
for
companies
worldwide
trading
in
Europe.
Medical
Device
Directive
–
EU
and
Canada
We
have
long
experience
of
working
throughout
the
U.K.
Europe
and
North
America
with
the
EU
Medical
Directive,
assisting
our
many
clients
in
satisfying
the
defined
requirements
of
the
Regulations.
The Canadian Medical Device Directive differs
very little from the EU Directive, imposing very similar requirements
in respect of controls and duty of care.
The European Medical Device Directive 93/42EEC:1993 details the routes
available to companies to achieve CE Marking accreditation
for individual product ranges and includes the specification
for labelling requirements, risk analysis and regulatory issues.
Once
having
satisfied
the
above
requirements
the
product
is
able
to
show
the
CE
Mark
symbol.
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