MU 2017 November December

44 MACHINERY UPDATE NOVEMBER/DECEMBER 2017 www.machineryupdate.co.uk
Feature: Pharmaceuticals
Medical
devices are
next in line
With the deadline set in place to comply
with the mandatory requirements of the EU
regulations relating to medical devices, we
talk to Domino about what this all means
Manufacturers of anything
from contact lenses to
pacemakers have now been
given a time frame to ensure
they have all the affected
areas of their business covered, including
product identification, to comply with
the EU MDR (European Medical Device
Regulation).
To help them along this road to
compliance, Domino has just produced
a comprehensive white paper which
is available from the company free of
charge. This highlights the multiple
aspects to take into consideration in
order to select the coding and marking
system that is best suited for a business.
These aspects include substrates and
materials, production volume and data
management, to name but a few.
MANAGE YOUR TIME FRAMES
More importantly, says the report,
manufacturers need to manage their
time frames as effectively as possible and
act now as sufficient time needs to be
allowed to test solutions and potentially
make the necessary adjustments to
manage the new coding requirements.
As background, under the FDA (Food
& Drug Administration) rule in the USA,
manufacturers have been required
to implement UDI (unique device
identification) on all medical product
packaging since 2014. Following this,
European manufacturers of medical
devices will face tougher regulations
to ensure their products are safe to use
under the new EU laws that are
scheduled to come into effect on 26 May,
2020 onwards.
Domino says that in terms of coding
and marking, the lessons learnt by the
company in the US market can be easily
transferred to the European one as
there is some overlap between FDA and
EU MDR requirements. The company’s
Global Life Sciences division shares
market information across the company’s
channels to raise awareness surrounding
medical devices, as well as the wider
requirements of the medical sector.
The new regulation will also see the
introduction of a new unique device
identification system, similar to the US.
This means that, for traceability
It is advances in
medical devices that
has prompted change
Device advances have led to the new EU rules
purposes, medical devices sold in EU
member states will need to include a
code, also known as a unique device
identifier, of which the details will be
recorded in an EU database.
With these laws coming into effect,
manufacturers now have a legal
responsibility to invest in a solution that
allows them to apply traceability codes
onto products as well as their packaging.
The classification of medical devices
is very similar to the US classification
but there are some minor differences.
Manufacturers will have to determine
what category of medical devices each
of their products belongs to, based on
article 51 and Annex VIII of the EU MDR
in which 22 rules are defined to help
classify each product.
Each class will have different time
frames for compliance.
Looking at the coding and marking
requirements, there are a few
considerable differences between the