Medilink North of England News Autumn Winter 2018 Volume 2 | Page 5
MEDICAL DEVICES (MDR) AND IN VITRO
DIAGNOSTIC MEDICAL DEVICES (IVDR)
REGULATIONS
REGULATIONS FOR MEDICAL
DEVICES - KNOW YOUR MARKET
WHAT YOU NEED TO KNOW AND WHY THAT MATTERS
ADNAN ASHFAQ, DIRECTOR OF PHARMI MED LTD.
In this feature we explore the perspectives of three organisations
working at the coal face of regulatory reform and implementation
THE IMPACT OF THE NEW EU DEVICE
REGULATIONS ON THE MEDTECH SECTOR
- JOHN WILKINSON, DIRECTOR OF MEDICAL DEVICES (MHRA)
We live in an increasingly digital
world where manufacturing
methods are evolving and new,
innovative technologies are
improving the way we treat
diseases and health conditions.
However, EU regulators struggled to
keep pace with the ever-changing
environment. Twenty-fi ve years
ago, when the Medical Devices
Directive was published, legislators
could never have predicted that
manufacturers would be 3D-printing
devices or manipulating human cells
to incorporate within devices.
The new EU Medical Devices (MDR)
and in vitro Diagnostic Medical
Devices (IVDR) Regulations, which
entered into force on 25 May 2017,
introduced this much needed update
to accommodate this evolving
landscape and create a more
thorough and consistent framework
for manufacturers, regulatory
authorities, and other relevant
actors to operate in.
Key changes have been brought
about with the MDR and IVDR
across almost all areas. Updated
defi nitions bring a number of new
product groups into scope, where
certain groups of products without
an intended medical purpose will
be regulated as medical devices
for the fi rst time. As well as
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introducing new risk classifi cation
rules, increased requirements
for clinical evidence mean that
manufacturers will need to closely
examine their portfolios for changes
in requirements. In addition to
more rigorous vigilance reporting
requirements, manufacturers and
authorised representatives will now
be required to employ at least
one person who will need to fulfi l
a number of responsibilities to
ensure regulatory compliance. Most
signifi cantly, there will be a greater
emphasis on traceability throughout
the whole supply chain through
the introduction of a unique device
identifi cation (UDI) system, enabling
greater control over safety alerts,
potential recalls and surveillance
tasks.
There are a number of additional
changes that the new Regulations
introduce to those mentioned
above, so we recommend that
you familiarise yourselves with
these and begin to implement a
transition plan for meeting the new
requirements. The MHRA’s guiding
principle remains that we ensure
patients are not disadvantaged;
that the UK will continue to play a
leading role promoting and ensuring
public health; and that industry
must be able to get their products
into the UK and EU markets as
quickly and simply as possible.
The EU Medical Devices Regulation
will be fully applied from May 2020,
during the implementation period
agreed with the EU. This would not
automatically follow for the new EU
Regulations for in vitro diagnostic
(IVD) medical devices, which does
not apply until May 2022. However,
Lord O’Shaughnessy stated in
September 2017 that elements of
both new Regulations have been
applied directly in UK law since
May 2017, meaning that devices,
including IVDs, can now be legally
placed on the UK market if they
are in conformity with the new
Regulations, invoking all relevant
requirements.
We at the MHRA are dedicated to
providing support and guidance to
industry and will be continuing to
upload helpful documents on the
new Regulations on our webpage,
so be sure to check these out.
HOW READY ARE YOU FOR
THE NEW MEDICAL DEVICE
REGULATION? (BSI)
The fi nal text of the new European Medical
Devices Regulation (MDR) has been published
in the Offi cial Journal of the European Union.
The Regulation entered into force on May 25th
2017, marking the start of the transition period
for manufacturers selling medical devices into
Europe.
Enter - 25th May 2017 and the much discussed new European
regulations replace both the IVDD 98/79 EEC and the MDD
93/42 EEC with the IVDR -2017/746 and MDR – 2017/745
respectively. The focus on the new regulations has been
increasing patient safety, lowering risk and putting more
responsibility in the hands of the legal manufacturer and also
the notifi ed bodies, making the launch to market more diffi cult,
with further layers of due diligence. So for anyone launching a
new Medical Device into Europe, here are a few things to think
about –
• Wider scope of regulated medical devices
• More stringent Clinical Evidence and documentation is
required (Medilink’s in-house team provide an extensive
service in this area to industry, please contact connect@
medilink.co.uk for further info)
• Increased focus on Identifi cation and Traceability including
UDI (Unique Device Identifi cation)
• Defi nition of Common Specifi cations
• Unannounced factory audits
The MDR, which replaces the Medical Devices
Directive (93/42/EEC) and Active Implantable
Medical Devices Directive (90/385/EEC), has a
transition period of three years. Manufacturers
have the duration of the transition period to update
their technical documentation and processes to
meet the new requirements. • Increased Notifi ed Body involvement
This long awaited text brings with it more scrutiny
of technical documentation; it addresses concerns
over the assessment of product safety and
performance by placing stricter requirements on
clinical evaluation and post-market clinical follow-
up, and requiring better traceability of devices
through the supply chain. • Large changes to economic operators – suppliers etc.
The start of this long process of change occurred
on 26 September 2012, when the Eur opean
Commission adopted a Proposal for a Regulation
of the European Parliament and of the Council on
medical devices and a Proposal for a Regulation of
the European Parliament and of the Council on in
vitro diagnostic medical devices, which replaces
the existing three Medical Device Directives.
The BSI Team is here to support you on your
journey, so please talk to us about your plans early
on in your preparation. Further information can be
found BSI MDR revision page www.bsigroup.com/
MDRRevision.
• More rigorous vigilance
• More focus on novel technologies, combination, software
etc.
• Changes in Classifi cations some Class IIa is IIb, some Class
IIb to Class III
• PSUR
• Implementing and delegating acts
• Common specifi cations where no harmonised standards
exist
• Authorised Rep – increased responsibilities
So which market – is EU right for you?
The US market has a 45% global market share, worth over
$180 billion, so bearing in mind the above challenges and the
potential knock on effect on timelines to reach market due to
the increased workload above, perhaps the US 510K route may
be a more amenable market for your device?
Submissions can take anything from one month to 30 months,
depending on Classifi cation and device risk. According to
Emergo, 142,000 devices have cleared FDA 510(k) approval
and that’s only 35% of the entire volume of devices, with the
remaining 65% of devices exempt from the 510 (k) process.
So perhaps the US market is worth looking towards for your
device as a lot of uncertainty currently looms over the EU
market. The take home point is – know your market, develop
a regulatory strategy, but above all do not take risks in your
regulatory approach.
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