1. European Proposed
Medical Device Regulation
(MDR) & In Vitro
Diagnostics Regulation
(IVDR)
A selective overview
Gert Bos
2nd Qserve Conference
18 nov 2013
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2. finding efficient pathways, identifying obstacles and hurdles
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20/11/2013
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3. regulatory environment that supports innovation
The MEPs
The Council
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4. Selective influence
EU Commission
EU parliament
EU Council
of Ministers
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5. Timelines:
2013
2014
2015
2016
2017
2018
2019
2020
2021
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
European Parliament vote - 22 October 2013
Potential finalisation – Q1/Q2 2014
Designation of Notified Bodies
3 Year Transition
3 Year Transition
Regulation covering MD & AIMD
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Regulation covering IVD
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6. Designation of Notified Bodies
and Special NBs
Expect delays this long………. – E.V.
Notified Body
MDR Class IIa/IIb**
IVDR Class B/C
*Class I non-sterile / non-measuring
**Under MDR Special NB needed for higher risk devices:
class III, implantable, devices intended to administer medicinal
products
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7. Structure of the IVDR
Chapters
Articles
Annexes
10
90
14
Annex I
•
•
•
•
General Safety and Performance
Requirements
Equivalent to the current essential
requirement
Broadly similar with additional clarification
New sections for software and
requirements for use with mobile platforms
Requirements for self tests are extended to
include near patient testing
Annex II Technical documentation
• Significantly more detail regarding the
expectations for technical documentation
Annex III Declaration of Conformity
Annex IV CE marking
Annex V
Registration and UDI
Annex VI Requirements for Notified Bodies
Annex VII Classification
Annex VIII Conformity Assessment based on
Full QA or Design Examination
Annex IX Conformity Assessment based on
Type Examination
Annex X
Conformity Assessment based on
Production QA
Annex XI Notified Bodies Certificate content
Annex XII Clinical Evidence and Post Market
Follow up
Annex XIII Interventional Clinical Performance
Studies
Annex XIV Correlation table
More detailed consistent with the proposed
Medical Device Regulation
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8. In Vitro Diagnostic
'in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product,
calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used
alone or in combination, intended by the manufacturer to be used in vitro for the examination of
specimens, including blood and tissue donations, derived from the human body, solely or principally for
the purpose of providing information:
• concerning a physiological or pathological state;
• concerning a physical or mental impairments;
• concerning the predisposition to a medical condition or a disease;
• to determine the safety and compatibility with potential recipients;
• to predict treatment response or reactions;
• to define or monitor therapeutic measures.
In vitro diagnostic medical devices used for DNA-testing shall be subject to this Regulation.
Commission Justification
So called lifestyle-tests should fall under the regulation as they could have enormous consequences for
the health of the patient/consumer. An extended scope therefore is important for protection of patients
and consumer in Europe.
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9. Increased Control of the Supply Chain
Manufacturer
UDI
OEM’s
Sub contractors
Distributers
Importers
Authorised
Representatives
UDI
Crucial Suppliers
• Increased expectation to hold technical
documentation during audits
• Notified bodies audit crucial suppliers / significant
subcontractors including unannounced visits
• Changes to contracts will be required
Public access in EUDAMED:
Allow comparison of devices, economic operators, clinical investigations, vigilance
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10. IVD Classification
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11. Classification
Class D (Blood screening)
• Devices intended to be used to detect the presence of, or exposure to,
• a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their
derivatives, in order to assess their suitability for transfusion or transplantation.
• a transmissible agent that causes a life-threatening disease with a high or currently undefined risk
of propagation
• Blood grouping ABO, Rhesus, Kell, Kidd and Duffy systems
Class C
Devices intended for
• detecting the presence of, or exposure to, a sexually transmitted agent;
• detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited
propagation;
• detecting the presence of an infectious agent, if there is a significant risk that an erroneous result
would cause death or severe disability to the individual or foetus, or to the individual's offspring;
• pre-natal screening of women in order to determine their immune status towards transmissible agents;
• determining infective disease status or immune status, if there is a risk that an erroneous result would
lead to a patient management decision resulting in an imminent life-threatening situation for the
patient or for the patient's offspring;
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12. Classification
*Companion diagnostic
means a device specifically intended for and essential to the
selection of patients with a previously diagnosed condition or
predisposition as suitable or unsuitable for a specific
therapy with a medicinal product or a range of medicinal
products;
Class C (Continued)
• selection of patients, i.e.
• Devices intended to be used as companion diagnostics*; or
• Devices intended to be used for disease staging; or
*Genetic testing
• Devices intended to be used in screening for or
means an IVD the purpose of which is to identify a
in the diagnosis of cancer.
genetic characteristic of a person which is inherited or
acquired during prenatal development;
• human genetic testing*;
• monitoring of levels of medicinal products, substances or biological components, when there is a risk
that an erroneous result will lead to a patient management decision resulting in an imminent lifethreatening situation for the patient or for the patient's offspring;
• management of patients suffering from a life-threatening infectious disease;
• screening for congenital disorders in the foetus
• Devices intended for self-testing are classified as class C, except those devices from which the result is
not determining a medically critical status, or is preliminary and requires follow-up with the
appropriate laboratory test in which case they are Class B.
• devices intended for blood gases and blood glucose
determinations for near patient testing* are class C. *Device for near-patient testing
means any device that is not intended for self-testing but
Other devices that are intended for near-patient
is intended to perform testing outside a laboratory
testing shall be classified in their own right.
environment, generally near to, or at the side of, the
patient;
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13. Classification
Class B
• Any IVD not listed under Classes D, C or A.
• Controls without an assigned value.
Class A
• Reagents, other articles with specific characteristics.
• Instruments intended specifically for use in IVD procedures.
• Specimen receptacles.
There will be clarification to the classification but no substantial change
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14. Conformity Assessment Routes
Self Tests also have to meet the
requirements in Annex VIII.6
Note Class D devices regardless of whether they are used in a single healthcare institution must meet the regulation with
the exception of the requirements for economic operators unless there is no CE marked device
Class A, B + C devices used within a single healthcare institution which have a single quality management system
compliant with ISO 15189 (Medical laboratories - Particular requirements for quality and competence) may be exempt from
the majority of the regulation; however, they must report adverse incidents.
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15. Additional Requirements for
Class D Devices
Summary of safety and performance
High risk devices (Class C and D) devices will
require a summary of safety and performance
which will be available to the public and should
be is clear to the intended user.
SUBJECT TO DISCUSSION
•
•
•
•
Highly likely to be some form of scrutiny for
selected high risk devices
Changed from the Medical Device
Coordination Group (MDCG) to the
Assessment Committee of Medical Devices
(ACMD)
There will be delays compared to the current
process
There may be additional fees
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16. Quantum Leap
IVD Directive
IVD Regulation
Require a Notified Body
Require a Notified Body
80-90%
Do not require a Notified
Body
80-90%
Do not require a Notified
Body
In house exemption continues – but with vigilance requirements for high risk devices
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17. Vigilance - IVDR
The regulation requires
• Reporting times without delay, and no later than 15 days after the
economic operators have become aware of the event and the causal
relationship with the device
• Describes periodic summary reports for similar serious incidents
occurring with the same device
• Trend reporting required for class C and D devices
Clinical
• Safety and Performance Report – required for class C and D
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18. Recently Published
COMMISSION
IMPLEMENTING
REGULATION (EU)
No 920/2013
of 24 September 2013
on the designation and the
supervision of notified bodies
under Council Directive
90/385/EEC on active
implantable medical devices
and Council Directive
93/42/EEC on medical devices
COMMISSION
RECOMMENDATION
of 24 September 2013
on the audits and assessments
performed by notified bodies
in the field of medical devices
Directs Notified Bodies
how to audit
manufacturers
Directs Competent
Authorities how to control
Notified Bodies
Effective from Jan 2014
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19. COMMISSION REGULATION
on designation and supervision of
notified bodies under AIMD and MDD
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20. Consequences so far
• Joint audits done in 11 notified bodies across EU
• Interim score: 2-2-2-2 (withdrawn, closed, suspended, reduced)
• Increased transparency
• identifies rules in practice for current audits by competent authorities.
• Very serious in depth critical assessments
• Will drive essential improvement processes within the notified bodies.
• “TEAM-NB supports this strong increase in supervision as we see that it
greatly enhances the performance of notified bodies.“
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2013 Medical Device Roadshow
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21. COMMISSION RECOMMENDATION
on the audits and assessments
performed by notified bodies in the
field of medical devices
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22. Commission Recommendation on the audits and
assessments performed by NBs
Annex I
Annex II
Annex III
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• Criteria for NBs performing design
dossier and type examinations
• Criteria for NBs performing QMS
assessments
• Unannounced visits to
manufacturers "critical
subcontractor" or “crucial suppliers”
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23. REVISION Code of Conduct
• Full day brainstorming on
unannounced visits in NB-MED
• Added details in CoC:
• Quick update – Q4 2013
• Detailed update – April 2014
www.team-nb.org
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24. Manufacturers’ Next Steps? PREPARE and PRACTICE
• Engage with your Notified Body to understand the rules
• Participate in regulatory forums in the EU to understand the rules
• Build a plan to facilitate unannounced audits with front line and back up personnel
• What happens when your RA/QA team are away team-building Las Vegas?
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25. Final Summary
This is happening
There is no grandfathering
Requirements and expectations are increasing
Keep up to speed and understand the impact to your organisation
Talk to your notified body about their plans for designation and
resource
• Classify your devices
• Look at the clinical data
you have, is it enough
how can you get
what you need?
• Discuss at management
reviews
•
•
•
•
•
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27. 2
7
Name:
Title:
Gert Bos
Head of Regulatory and Clinical Affairs (NB0086 & NB0535)
Head of Notified Body (NB0535)
Address:
BSI
Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes, MK5 8PP, UK
Mobile:
+31 (0)6 50459651
Home-ofice:
+31 (0)8500 21471
Email:
Gert.Bos@bsigroup.com
Links:
www.bsigroup.com/healthcare
www.linkedin.com/in/gertbos
@bsihc
@gertwbos
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