CE2012 EU Medical Device Regulatory Revision Conference
Europe
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Overview of Actors and Roles
European Commission and Member States
Registrations
Surveillance
Enforcement
Competent
Authority
Manufacturer
Designation
Surveillance
Enforcement
Certification
and Audits
(Inspections)
Notified Body
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
The Revision is nearly with us and today we aim to gather insights into
what is coming, why and what it means to key stakeholders.
The Recast/Revision
of the
Medical Devices Directives
– problems and solutions?
Trevor Lewis, Principal Consultant
Medical Device Consultancy
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Proviso!
My presentation is dependent upon an unofficial draft of
the changes and related discussions with well informed
individuals.
Other speakers are likely to be better informed of the actual
content of the Revision than me but I can say things that
they just cannot possibly comment on!
Alan Kent has explained how we got here and what the big
global trends are.
My aim is to encourage you to think about what matters as
regulatory hurdles keep rising.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
What characteristics should a good regulation have?
In the UK (and similarly beyond) they should follow the
Hampton Principles:
 Regulators should recognise that a key element of their
activity will be to allow, or even encourage, economic
progress and only to intervene when there is a clear case
for protection.
 Regulators, and the regulatory system as a whole, should
use comprehensive risk assessment to concentrate
resources in the areas that need them most.
 Regulators should provide authoritive, accessible advice
easily and cheaply.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
What characteristics should a good regulation have?
In the UK (and similarly beyond) they should follow the
Hampton Principles:
 No inspection should take place without a reason.
 Businesses should not have to give unnecessary
information or give the same piece of information twice.
 The few businesses that persistently break regulations
should be identified quickly and face proportionate and
meaningful sanctions.
 Regulators should be accountable for the efficiency and
effectiveness of their activities, while remaining
independent in the decisions they take.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Does the Medical Device Regulation today achieve the
Hampton Principles?
 In the UK and most of Europe the answer is: Yes but we
can always do better.
 Medical Device regulators need to be seen as effective,
until recently Trading Standards and especially the
Advertising Standards Agency (ASA) were seen as having
much more effective teeth.
 IVD Directive (IVDD) classification of diagnostics was not
risk based and means the regulations are not really
applied in a risk based, proportionate manner. The
change to a risk based GHTF like system is then clearly
warranted and universally accepted as appropriate.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Further characteristics of good regulations...
 Good regulations are fair: risk based, appropriate,
proportionate, and do pay due consideration to
economic considerations.
 Good regulations are enforced and seen as effective by all
stakeholders. Persistent transgressors must know they will
be punished not just warned...
 Good regulations need to be seen as beneficial to those
subject to them, i.e. the medtech industry.
 Good regulations evolve with time and radical changes
are only made if absolutely required.
 Are the likely changes represented by the Revision good
regulations?
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Science Based
Regulation
throughout the
TPLC
After more than 100 years of healthcare industry regulation FDA is
still working on its ever evolving system, including most recently
‘Strengthening Our National System For Medical Device Postmarket
Surveillance’ published September 2012.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
FDA improved
PMS system
proposal
September 2012
We can expect
The Revision to
have similar
elements in it...
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Most stringent ERs and
regulations
Class III, few devices
highest risk
MDD
Risk
FDA
%
Class I
Low
Class I
46%
Many IVDs / waived tests
Most ERs apply,
“modest touch”
Minimum ERs and
documentation,
“light touch”
Class II, most devices
modest risk
Class I, many devices
low risk
Class IIa / IIb
Medium
Class II
47%
Most moderate risk /complex IVDs
Class III
High
Class III
7%
List A/B or high risk (consequence) IVDs
Vol. of docs /
No. of devices
Device
& Risk
As weClassification
have heard from
Alan Kent,
global convergence is alive and
well with the IMDRF, including
exchange of information between
regulators.
I note that FDA have been very
critical of the European approach
and the cozy relationship
between manufacturers and
Notified Bodies (NBs).
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
The Regulatory Environment is Dynamic and Important…
European Union
The Medical Device Directives
including the In Vitro Diagnostics Directive (IVDD)
is under review.
The Revision Regulation is expected next week.
United States of America
Food and Drug Administration (FDA) that has lots of useful guidance. The 510(k)
premarket submission is under reform right now.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Its not just The Revision its about changing compliance too…
EN 60601-1:2006 Medical electrical equipment. Part 1:
General requirements for basic safety and essential
performance became obsolete on the 1st June 2012
and is replaced by the 3rd Edition.
The 3rd Edition is risk based and demands the use of:
EN ISO 14971: 2009 Medical devices - Application of
risk management to medical devices.
The 3rd Edition sets the state of the art for electrical
safety, EMC and software safety in medical devices
and by association for in vitro diagnostics too.
These European Standards do not necessarily cover the requirements introduced by
Directive 2007/47/EC.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
These European Standards are important and currently harmonised to the IVDD.
EN 61010-2-101:2002 Safety requirements for electrical
equipment for measurement, control, and laboratory use - Part 2101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
EN 61326-2-6:2006 Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part 2-6: Particular
requirements - In vitro diagnostic (IVD) medical equipment
EN 62304:2006 Medical device software - Software life-cycle
processes.
EN 62366:2008 Medical devices - Application of usability
engineering to medical devices.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
A recent unofficial draft of the proposed new Medical Devices
Directives does provide insights into the likely changes and more
importantly the direction of travel...
... as it has been discussed by the Medical Devices Expert Group
(MDEG) but scope excludes IVDs.
The changes are less dramatic than originally feared and have
resulted in the process being termed (under EU comitology
procedures) a Revision and not a Recast.
It is almost certain that the Revised IVDD will have different
classification risk as expected using the GHTF system (rules
based classes A-D).
It is considered likely (especially in the UK) but not certain that the
use of in-house (home brew) tests for companion diagnostics /
stratified medicine – will retain exemption except for the highest
risk categories.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Rule 3: Class C
devices intended to be used as companion diagnostics,
for disease staging and in screening for – or in the
diagnosis of – cancer, as well as for screening for
congenital disorders in the foetus;
genetic tests;
tests for detecting an infectious agent, an infective
disease or immune status where there is a risk that a
wrong result would cause death or severe disability, or
lead to a patient management decision resulting in an
imminent life-threatening situation, to the individual or
foetus tested, or to the individual’s offspring
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CE2012 EU Medical Device Regulatory Revision Conference
Rule 10: where standalone software falls within the
scope of the definition of an "IVD medical device", and
drives a separate IVD medical device or influences the
use of the device, the software falls automatically in the
same class as the device; where it is not incorporated
in an IVD medical device, it is classified in its own right
in accordance with the above-mentioned classification
rules.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
It is very likely the Revised IVDD will demand more clinical
evidence for all but the lowest-risk, Class A products. This is
expected and typically global IVD manufacturers have looked to
meet the more stringent FDA requirements. CE was seen, until
recently as a sub-set of required FDA documentation.
The Revised IVDD is likely to be implemented across the EU
during 2015 or 2016 and is likely to be a Regulation (as proposed
for devices) and so will become effective soon after it is published.
All manufacturers will need / would be well advised to have a postmarket clinical follow-up plan consisting of documented methods
and procedures to pro-actively collect clinical evidence data from
actual use of the device. This data is then expected to be used in
the development of risk management, design and clinical
performance documentation. This requires a database that works
transnationally!
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
There will be more work and added costs for
IVD manufacturers…
The risk based classification system for IVDs will result in many
more IVD companies requiring the use of a Notified Body (NB)
before products can be CE marked and placed on the market.
Overall these most likely of changes are most likely to be accepted
by most stakeholders as ‘good regulations’.
Yes there will be some additional costs to industry but this is fully
warranted, especially for molecular and companion diagnostics.
I will leave further comments to Doris-Ann Williams of BIVDA.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
EU “BLUE GUIDE” or “BLUE BOOK”
Guide to the implementation of
directives based on the
New Approach and
the Global Approach.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Review of the New Approach
The New Legislative Framework
The New Approach has recently been reviewed but
changes relatively little for medical device
manufacturers. For more please see:
http://ec.europa.eu/enterprise/newapproach/review_en.htm
Changes are applicable from 1 January 2010.
Economic operators defined to include manufacturer,
authorised representative, the importer and distributor.
Economic operators should take appropriate measures
to ensure they only make available products in
regulatory compliance.
This change needs to be in The Revision.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
MDEG Concerns Prior to 2007 Revision
Notified Body examination of design for conformity
assessment.
The sufficiency and adequacy of clinical data for all classes
of device.
Coordination of post market surveillance.
Competence of Notified Bodies.
General public awareness of device approval.
These concerns still remain from my perspective, but
there are emerging improvements in all of the above.
The Revision is expected to continue this theme.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
What did the 2007 Revision Try to Do?
Resolve issues arising from technical progress, multiple
interpretations and misunderstandings.
Attempted to force industry to take clinical evaluation more
seriously.
However it inevitably created further issues to keep everyone
engaged in dialogue for the foreseeable future.
The 2012 Revision is likely to reinforce this current situation
and a more fundamental Recast has been rejected.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
What are the Regulatory Hurdles?
Validation of Product Design, especially EMC (Electromagnetic
Compatibility) & Software.
Risk Management for product, processes, Quality Management System
(QMS) and Clinical Evaluation.
Pre-Clinical Testing.
Validation of Clinical Evidence, i.e. Clinical Literature Review and
Clinical Investigation for devices. For IVDs analytical laboratory
testing, Performance Evaluation and Clinical Validation.
Human Factors Engineering – more than usability.
Post Market Surveillance (PMS).
Competence of Notified Bodies.
Reimbursement and Health Technology Assessment (HTA).
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
Definition of ‘making available on the market’ replaces
‘putting into service’ and removes some confusion.
‘Importer’ ‘Distributor’ and ‘Economic Operator’ defined to
align with the Recast of the New Legislative Framework.
Those listed above must ensure products are compliant!
Definitions for ‘recall’; ‘withdrawal’; and ‘harmonised
standard’ may be added so as to be clearer about some
post-market surveillance requirements.
The poorly understood ‘device subcategory’ and ‘generic
device group’ may be modified or clarified.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
Further new definitions for ‘single use device’; ‘conformity
assessment body’; ‘nanomaterial’; ‘health institution’;
‘field safety corrective action’; ‘field safety notice’; ‘clinical
investigation’ and more expected.
Any product using ‘nanomaterials’ will be Class III, unless
bound/encapsulated with no release to patient possible.
The definition of ‘qualified person’ may be added too.
All of these definitions will require careful study by both
manufacturers and legal counsel.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
Labelling to move closer towards the GHTF guidance on
labelling, to enable manufacturers to have more
‘international’ labelling – hopefully reducing costs.
Own Brand Labelling requirements will probably be
clarified and the name for agreements with brand owners
explicitly stated.
The need to inform users of residual risks might be
extended to include/encourage training of users [...where
deemed appropriate, proportionate to the risk and cost
effective to do so?]
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
Implantable or other invasive products, intended for
human beings are likely to be classified as medical
devices irrespective of the claims made by the
manufacturer. This change might also be extended to
non-corrective contact lenses; facial or other skin fillers;
equipment for liposuction; and surgical laser equipment.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
More regulation of single use devices, especially those
that are reprocessed, is highly likely and many have
lobbied hard and long for such changes. For many
observers this is long overdue.
‘Making available on the market’ will most likely bring in
the concept of properly installing and maintaining a
device. For many observers this is long overdue.
All medical devices made available, except custom
devices or intended for clinical investigation, must include
a clinical evaluation to demonstrate conformity with the
Essential Requirements.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
The General Essential Requirements (1 to 6) will remain
but could be worded to better align with the GHTF
Essential Principles.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
In Vitro Fertilization (IVF) or assisted reproduction
technologies (ART) likely to be regulated as Class IIb
devices.
Some ingested devices for transient use will probably be
regulated as Class IIb devices and short- to long-term
devices as Class III devices.
Class III devices will probably require a full quality system
and design dossier examination prior to placing on the
market. Type testing should still be possible.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
Notified Bodies (NBs) ‘involvement’ in the conformity
assessment process will be more clearly spelt out
NBs and manufacturers will need to set and agree time
limits to the implementation of corrective actions.
The expected ‘degree of rigour’ for NBs assessments is
now likely to explicitly stated. This sadly is required.
It is good to know positive words and phrases are likely to
be used, such as:
‘In so doing, NBs shall act in a proportionate manner,
avoiding unnecessary burdens for economic operators.’
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
Whilst it is understood to have been rejected, early drafts
of The Revision do consider, upon duly justified request of
MDEG, review of conformity assessment of high risk
devices by MDEG or the Commission.
These would be probably be a rare process and reserved
for those highest risk products, extremely novel devices,
products with a significant impact on public health, or has
some evidence of discrepancies from different NBs.
Note that change of NB will require a structured handover
with appropriate checks been documented.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
Certificates of free sale should be more readily available
following The Revision and this is clearly welcomed.
The need for a product to have a Unique Device
Identification (UDI) is possible (to eventually most probable)
and should again be helpful – provided only one system is
used globally...
There could be encouragement, via the Directives, to ask
medical practitioners and/or medical institutions to report
adverse incidents electronically where this is possible.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Key Points Likely in The Revision of Medical Device Directives
Post-market clinical follow-up will most probably have its
own section and reinforce the need for continuous process
to collect and evaluate clinical data systematically in the
post-market phase. A plan will be expected!
The use of ‘Expert Panels’; ‘EU Reference Laboratories’
and ‘Scientific Advice’ have definitions and remits that
mirror many of the activities of similarly named bodies well
established by the Food and Drug Administration (FDA)...
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
The EU Data Protection Directive (Directive 95/46/EC) is
under revision and a new version is expected to be
published during 2014.
Future fines for non-compliance could be as high as 2% of a
company’s world-wide revenues! Plus various bans on
processing data.
It is an important area to monitor as the draft develops and it is
important to realise it will most likely affect patient records and
clinical decision support systems implementation.
Taking legal advice once the changes are clear is considered
vital.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Remember the RoHS Recast will
apply to medical devices from the
22nd July 2014
and for IVDs from the 22nd July 2016.
REACH is with us now!
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
The Regulatory Journey
•
Regulatory compliance, just like quality, is not a destination but a journey.
•
Everything is legitimately subject to continuous review.
•
The STATE-OF-THE-ART is enshrined into all the medical device directives and
features in strict liability and consumer protection law all around the world.
•
A key aspect of assessing what is expected is the reasonable expectations of the
consumer – as determined in a Court of Law.
•
Even with no Directives and no Code of Federal Regulations it would still be
necessary to undertake due diligence in all things, act with a duty of care and be
responsible taking into account all possible factors that make a product safe and
do what it is supposed to do without undue harm.
•
The implementation of compensation due to neglect or deliberate act dates back
to English Common Law during the 13th Century, possibly earlier.
•
The compensation culture is nothing new and is not an American invention,
although it is clearly taken to extremes in the USA.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
The Important Things
•
Understand the clinical need and all relevant stakeholder’s perspectives.
•
Never under estimate the importance of Human Factors Engineering (HFE).
•
Create concepts, test them and use Ready – Fire – Aim where you can.
•
Do market research, study users and patients, look at the Total Product Life
Cycle (TPLC) of competitors, substitute technology and possible alternative
clinical pathways – you will gain profound insights.
•
Do write requirements specifications so you can generate Design Inputs and
Design Outputs, i.e. know what you are going to produce and how to prove it
when you do.
•
Do work within a QMS to ISO 13485 so you can prove to YOURSELF and
any inspector/auditor that you are in Demonstrable Control at all times and
in all places.
•
Make Evidence Based Scientific Decisions and ensure these are robust
and where possible or demanded are subject to appropriate Peer Review.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
The Important Things
•
Never under estimate the importance of Ethical Review and do get truly independent advice before
embarking on anything that uses significant resources.
•
Always validate the clinical need has been met and review the entire design following initial use by real
users/patients, in real life situations and refine your aim towards the best possible product you can create
cost effectively.
•
Always ensure all types of validation wherever and whenever possible are undertaken as independently
as possible. Do not fool yourself or your colleagues – delusions always come back with a bite that hurts.
•
Keep close to your TEAM – R&D / D&D, the supply chains, your distribution chain, manufacturing,
regulators and most importantly close to your customers and patients.
•
DO plan for several rapid iterations of design and validation that will improve your Ready – Fire – Aim
route to success.
•
Keeping checking and monitoring the market research, users / patients, competitors, substitute
technologies and possible alternative clinical pathways – do not get surprised at launch!
•
Do keep up-to-date with all regulatory requirements, relevant standards and guidance documents.
•
Remember in Europe there are always at least two Directives that apply to every product, often it is many
more and six is fairly common for electrical/electronic products. Do consider the environmental
Directives and regulations from the start as an equally important to anything else.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
The Important Things
• Do not rely on Regulators / Notified Bodies, Consultants,
Lawyers, the Public, Doctors, Patients or anyone else to ensure
you comply – as the legal manufacturer you are responsible
for everything.
• You need to ensure you have the time to keep up-to-date and
understand the ever changing state-of-the-art of medical device
regulation.
• You need to read, to learn, to lead, to motivate, review and do
all the routine things well, that we all do everyday, to make
progress in our regulatory lives. Nearly all medical device
businesses require teams of specialists and partners to make
things happen and ensure compliance. So we all need to be,
especially Top Management, good listeners and be open to
learn from our teams and others.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
The key takeaways?
Appropriate, proportionate and cost effective regulation of medical devices,
including IVDs and various combination devices really matters to public health
and wealth. Getting it wrong can cost lives and be expensive to fix.
Note a diagnostic test can help keep a drug on the market, or indeed be vital in
getting a drug to market!
Co-development of IVDs, biologics and drugs is going to increase.
The importance of clinical evidence is increasing, can you substantiate your
product claims when subject to truly independent peer review?
The regulations are hardly required for those who develop and/or sell innovations
with scientific rigour and due consideration to the ethics of use.
Regulations are vital to guide or control those who resent controls or are prepared
to cut corners for whatever reason.
Cost always matters and economic considerations have to be part of the equation.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Enforcement? We are not talking about...
...but perhaps we should!
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Q&A
– please wait for the panel session.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
New EDMA tag line (28Nov11): “Diagnostics for Health”
http://www.edma-ivd.eu/about-in-vitro-diagnostics
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Diagnostics Development: Fragmented Landscape, Lack of
Advocacy and Investment
R&D: 2-10 years; $ 10-100 million
Diagnostic
Targets
Target Product
Profile
Product
Prototype
Regulatory Approval: 2-5 years
Proof of
Principle
Lab & field
evaluations
Policy and
guidelines for
use
Test
adoption
Technology
platform
Policy & Uptake 5-7 years
Courtesy of Prof. Peeling, Diagnostic Research London School of Hygiene & Tropical Medicine
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
Question: Do you wish to access 90%+
of the world’s market for medical devices / IVDs?
Typically in the past:
USA 40% to 50% typical
Europe ~ 30%
Japan 15% to 20%
ROW balance but:
Canada, Australia & New Zealand
3% to 5%
Brazil, Russia, India, China & Turkey (BRICT)
are becoming ever more significant.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
FDA Proposals (expectations) for companion diagnostics:
Draft guidance completed 15th January 2012 and a final version
is in progress, originally expected by 30th June 2012.
Provides definitions and indicates general policies.
Trials must be conducted under full IDE Regulations, i.e. a
submission and review by FDA is required. A ‘pre-IDE’
consultative process is highly recommended.
Please download from:
www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/UCM262327.pdf
Please remember the European Medicines Agency (EMA) Qualification
of novel methodologies for drug development: guide to applicants
that discusses the regulation of biomarkers for companion diagnostics.
This does cover “....biomarkers, imaging methods or other drug
development tools”.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
510(k) Reform key points:
The use of split predicates to end.
The use of reference devices allowed but
ideally the single predicate should be
‘substantially equivalent’ in regard to both
‘intend use’ / ‘indications for use’ and
technology used.
Otherwise a ‘hybrid’ 510(k) with
prospective clinical performance data or
PMA may be invoked.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
FDA Vs CE – which is best?
• Recently and periodically over many years this question has been
raised or arguments have arisen about which regulatory approach
is best: FDA or CE?
• All regulatory systems need to continually and progressively
evolve and improve over time.
• Being a regulator is not a destination but a journey.
• The regulations in the US and EU represent only the minimum
and provide guidance as to what is expected from manufacturers who should always be striving to first ‘do no harm’ and only
provide fully compliant products whose benefits outweigh the
associated risks.
• All regulation should ideally be reasonable, appropriate,
proportionate and pay due regard to economic considerations.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
FDA Vs CE – which is best?
•
However for a regulatory system to work it must be respected and be used by
manufacturers who strive for high standards in all their endeavours.
•
If manufacturers do not read the regulations, do not keep up-to-date, complain they
have no means to sustain the required resources and do not lead their teams to
excellence, then they get what they deserve.
•
Everyone during their life is a consumer and benefactor of medical devices.
– Currently the public, especially in Europe, feel let down by some medical device
manufacturers and this undermines the confidence in all the industry, however
unfair this may be.
•
All regulators must provide confidence to society that they are effective in what they do,
anything less is failure.
•
Both the FDA’s approach and CE approach is imperfect and there will always be ways in
which both can improve.
•
FDA is more prescriptive and generally recognised as tougher to get through, the
regulator is centre stage.
•
CE marking relies on and centres mostly on the manufacturer and provides enormous
flexibility in approach.
•
Please note that both FDA and CE work best where they are superfluous.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
FDA Vs CE – which is best?
• So why, with so much common ground concerning compliance and the
clear need to be duly diligent, is there any discussion?
• The regulations are not the problem, it is how they are used,
interpreted and implemented that is crucial.
• The FDA has established the need for a robust science based
approach and demands rigour when it matters.
• CE marking, as currently practised, has an interpretation and
implementation that often allows a less rigorous scientific approach
and this sometimes results in products being placed on the market that
either should not be there, or should not be there without significant
modification.
• The current experience and evidence Medical Device Consultancy
sees suggests the current use, interpretation and implementation of
regulations by FDA is more effective than that in Europe.
Both FDA and CE work best where they are superfluous.
Medical Device Consultancy
CE2012 EU Medical Device Regulatory Revision Conference
CE Marking and Revisions / Recasts
The final message of this discussion is simple:
Make it work!
CE marking is in many ways a much better system
than FDA’s, from a manufacturer’s perspective, provided
it is used, interpreted and implemented using a robust
rigorously scientific evidence based approach to
regulatory compliance – irrespective of jurisdiction!
If European industry fails to make ‘CE’ work in the next
few years, then a truly draconian prescriptive system will
inevitably follow...
....this will not serve society’s or patient’s best interests.
Medical Device Consultancy