1. LIFE SCIENCES1 | ARTHUR COX
White Smoke Emerges: New
Medical Device Regulations
finally published
Group Briefing
June 2016
Initiated against the backdrop of the
well-documented PIP breast implant
issues, the new Regulations have been
the subject of rigorous scrutiny and
comment for the past four years. On
14 June 2016, the agreed texts of the
Regulations were finally published
on the Parliament’s website which
brings us closer to, arguably, the biggest
legislative overhaul in the history of the
medical device industry.
Furthertoourpreviousalertonthisissue,
belowaresomeofthekeyelementsofthe
newRegulationsonmedicaldevicesand
invitromedicaldevices.
DEFINITION OF MEDICAL DEVICES EXPANDED
The definition of medical devices is
expanded to include, amongst others,
devices with purposes related to
prediction and prognosis of diseases.
This will have a significant impact on
quantification products and services in
the field of health-related parameters
which could now fall within the scope
of the new Regulations. Companies
operating in the mHealth sector would
also be advised to bear in mind any
potential impact the draft European
Commission guidelines on mHealth
may have on their products.
The Regulations will also apply to a
group of products without an intended
medical purpose that are listed in
Annex XV, such as contact lens,
equipment for liposuction and products
used for tattooing. These products will
have to meet common specifications
that address risk management and,
where necessary, clinical evaluations
regarding safety.
REPROCESSING
Reprocessing represented one of the
most contentious points during the
negotiations with some stakeholders
strongly in favour of allowing
reprocessing by default while others
were strongly against such activities
without the consent of the individual
Member States.
Reprocessing refers to enabling a
device to be safely reused through
cleaning, disinfection, sterilisation and
related procedures, including testing
and restoration of the technical and
functional safety of the previously
used device.
According to the text of the new
Regulations, reprocessing of devices
will only be permitted in accordance
with individual Member State
legislation which may prohibit such
reprocessing. The Commission is
tasked with drawing up a report within
four years after the date of application
of the Regulations on the operation
of these provisions and submit it to
the European Parliament and to the
Council for consideration.
This document contains a general summary of
developments and is not a complete or definitive
statement of the law. Specific legal advice should be
obtained where appropriate.
ARTHUR COX - KEY CONTACTS
If you have any questions on this
briefing please contact one of the Life
Sciences team at Arthur Cox:
COLIN KAVANAGH
PARTNER
+353 1 618 0548
colin.kavanagh@arthurcox.com
ORLA CLAYTON
SENIOR ASSOCIATE
+353 1 618 0437
orla.clayton@arthurcox.com
CIARA FARRELL
ASSOCIATE
+353 1 779 4368
ciara.farrell@arthurcox.com

2. Dublin
+353 1 618 0000
dublin@arthurcox.com
Belfast
+44 28 9023 0007
belfast@arthurcox.com
London
+44 207 832 0200
london@arthurcox.com
New York
+1 212 782 3294
newyork@arthurcox.com
Silicon Valley
+1 650 943 2330
siliconvalley@arthurcox.com
arthurcox.com
LIFE SCIENCES2 | ARTHUR COX WHITE SMOKE EMERGES: NEW MEDICAL DEVICE
REGULATIONS FINALLY PUBLISHED
NOTIFIED BODIES
The Regulations will further tighten the
rules for the independent bodies that
are responsible for assessing medical
devices before they can be placed on the
market (the so-called “notified bodies”).
The Regulations introduce stricter
designation requirements for these
bodies and it remains to be seen whether
current notified bodies will have the
capability and competence to meet these
new requirements.
The rules will give these bodies the right
and duty to carry out unannounced
factory inspections. While this is
something that is happening already,
companies need to be prepared for this
type of “dawn raid”.
HIGH RISK DEVICES
Controversially, certain high-risk
devices, such as implants, may undergo
an additional check by experts before
they are placed on the market.
The conformity assessment procedure
for these devices can include the
intervention of expert panels, designated
by the European Commission. Notified
bodies may seek advice from an expert
panel on applications for conformity
assessment for such devices. The notified
body shall give due consideration to the
views expressed by the expert panel.
Where the expert panel raises concerns
about certain matters such as the
sufficiency in the level of clinical
evidence or serious concerns about the
benefit/risk determination of the device,
the notified body is required to advise
manufacturers to take certain action to
address those concerns. In the event that
the notified body has not followed the
advice of the expert panel, the notified
body shall provide a full justification.
Inadditiontotheaboveprocedure,
anewlycreatedMedicalDevice
CoordinationGroup(“MDCG”)and,
whereapplicable,theEuropean
Commission,mayindependentlyrequest
scientificadvicefromtheexpertpanelsin
relationtothesafetyandperformanceof
anysuchhighriskdevices.
UNIQUE DEVICE IDENTIFICATION FOR DEVICES
Manufacturers will be required to place
a Unique Device Identification (“UDI”)
on their medical devices to ensure
traceability. The UDI will need to be
included on the label of the device.
Entities involved will be able to identify
from whom and to whom a device has
been supplied in a “one step back”-“one
step forward” approach.
The UDI will include information
concerning the identity of the device,
any warnings, precautions or measures
to be taken by the patient or a healthcare
professional and a description of
potential adverse events.
CLINICAL INVESTIGATIONS
With a backdrop of increasing
transparency in the area of clinical
trials for medicinal products, the
new Regulations aim to improve the
availability of clinical investigation data
on devices.
Sponsors of clinical investigations will
be required to publish the results of
clinical investigations and a summary
of the results in layman’s language
on Eudamed which will be available
to the public. Eudamed is a database
for information on medical devices
collected by competent authorities and
the European Commission. Presently,
only such competent authorities and
the European Commission have access
to Eudamed. The Regulations will now
grant access to Eudamed to a broader
spectrum of stakeholders, including
members of the public.
These documents must be published
on Eudamed regardless of the outcome
of the investigation and must be done
within one year from the end of the
investigation or within three months
from its early termination or halt,
whichever is the earliest.
NEXT STEPS AND TIMELINES
The Regulations still have to be
formally adopted by the Council and
the Parliament which is expected to
be completed by the end of this year
following legal review and language
translations in the coming months. It is
widely anticipated that the Regulations
will be adopted without any major
alterations to their current form.
The new rules will apply three years
after publication for medical devices and
five years after publication for in vitro
diagnostic medical devices.