MU 2017 November December

www.machineryupdate.co.uk NOVEMBER/DECEMBER 2017 MACHINERY UPDATE 45
Feature: Name here
Pacemakers are included in regulations
The white paper helps manufacturers prepare for the upcoming EU medical device regulation
FDA regulation and Europe. For example,
the CE logo and the letters ‘MD’ need to
appear in a designated square on each
label to indicate that an item is a medical
device. Manufacturers can decide to print
all the data or have some of the static data
pre-printed.
Some products will be very similar,
but only vary in size or name. In this
case, it is recommended to not use preprinted
labels and print both the static
and variable data to avoid mistakes and
to minimise stock costs.
The variable data – the UDI-PI
(UDI-Production Identifier) – has to be
printed on the lowest packaging level.
The current rules relating to the safety
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and performance of medical devices in
the EU date back to the 1990s. However,
it is the substantial scientific and
technological advances in the medical
sector that have taken place since their
implementation that has prompted the
EU Commission to update the rules.
The role of coding and marking in the
medical sector is a good one. Codes on
medical devices results in more efficient
product recall procedures, the reduction
of medical errors, as well as increased
inventory visibility and supply chain
security. The unique codes are crucial to
unlocking the so-called ‘chain of custody’
in the event of a recall.
Failure to comply with the new
legislation will have negative
repercussions on manufacturers as they
will no longer be able to supply their
products to other EU member states.
Fee payers and healthcare providers will
not accept devices without UDI codes that
are up to the required standard.
As a result, manufacturers now face a
responsibility to familiarise themselves
with the exact requirements of the
legislation and ensure they have a coding
and marking solution in place.
Domino’s white paper outlines all of
the coding and marking technologies
available to the medical sector for
primary, secondary and tertiary
packaging to help medical device
manufacturers tackle compliance
issues. By taking action ahead of the
deadline and partnering with a reliable
supplier and partner that can provide
the guidance and industry knowledge
required, compliance can be successfully
achieved, says the company.
T 01954 782551
E Lifesciences@domino-printing.com