The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include: - Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance. - Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain. - Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic

1. EU MEDICAL DEVICES
AND
IN VITRO DIAGNOSTICS
REGULATION UPDATE
Advamed Webinar
25 April 2016
Erik Vollebregt
www.axonadvocaten.nl

2. Process and progress
• Next step now: trialogue

3. Process MDR
As per end 2015 remaining “political” items
for MDR include:
• CMR substances
• Mandatory liability insurance for
manufacturer and authorised
representative
• Mechanisms for surveillance and
appointment of the Notified Bodies
• Scrutiny mechanism for certain high risk
devices;
• Reprocessing of single use devices
• Tasks of the proposed Medical Device
Coordination Group;
• Clinical investigations
• Transitional periods
• Classification rules
3

4. Process IVDR
As per end 2015 remaining “political” items
for IVDR include:
• Genetic testing
• Mandatory liability insurance for
manufacturer and authorised
representative
• Mechanisms for surveillance and
appointment of the Notified Bodies
• Scrutiny mechanism for certain high risk
devices;
• Clinical performance studies with IVDs;
• Post-Market Surveillance;
• Tasks of the proposed Medical Device
Coordination Group;
• Role of expert panels and reference
laboratories.

5. The last news from the Presidency
• 2 trilogue meetings have taken place
• Willingness between the three parties to agree before 1 July 2016
• This means MDR and IVDR regulations finished and adopted by end
2016
• Transitional regime likely three years

6. We have a final text, and then?
• Many instances of
delegated and
implementing acts are
necessary to make the
MDR and IVDR operational,
many of which impact
companies directly
• Unclear when these acts
will be available;
Commission is not obliged
to take them
• Industry is supposed to be
consulted on acts in
preparation (in practice
MedTech Europe / COCIR
will be consulted)
e.g.:
• regulatory status of (groups of)
products
• Essential Requirements
• Common Specifications
• Summary of Safety and
Performance format
• UDI, EUDAMED
• Notified body requirements and
assessment procedures
• Clinical performance evaluation
requirements
• EU measures against
unsafe/non-compliant devices
• Designation and functioning of
EU reference labs
6

7. Key MDR changes
Item Impact
Clinical Evidence More pre- and post-market data,
PMS plans,
frequently updated CERs
Limited Equivalence Discontinuation or fresh clinical
data
Class Ill and Implants with a long
history of safe use
Invest in pre- and post-market
clinical
Discontinue or invest
Post-Market Monitoring More PMCF, PSURS, annual CERs
New vigilance and annual reporting
More transparency, user and
patient access
Scrutiny Unpredictable launch, delay,
conflicting reviews

8. Key MDR changes (2)
Item Impact
Technical assessment of class lib
implants according to the class Ill
requirements
Additional costs and de-facto up-
classification of
class lib implants to class Ill
Reprocessing Regulation Increased or decreased industry
involvement and level of patient
safety pending outcome
Technical files to be constantly up
to date and readily searchable
New content plus IT system with
real time data from various systems
incl. suppliers
Economic operators regulated Integrate in manufacturers QS or
duplication of compliance activities

9. Key MDR changes (3)
Item Impact
Eudamed / UDI IT solutions, pre- I post-market
data,
(re-) registration fees, labeling,
national vs. EU database?
Up-classification of spine products
and reusable class I
Clinical investigations, design
controls, more audits
Transitional Period Prioritize re-launch, MDD I MDR
decision, capacity, talent,
operational readiness of NB’s
Restricted Substances Product- Component Assessment
Tracking systems I product design
Administrative Burden Each and every label to be updated
Implant cards for all implants, UDI-
DoC link

10. IVDR key changes
• Operational impact on
generic large multinational
IVD company

11. Chapter I – Definitions

12. Definitions MDR
Subject Before entry into force During After
Chapter I
Definitions
Check if cosmetic implant or other product is on Annex XV list Look out for Common Specifications for Annex
XV devices and implement them
Check if devices fall in enlarged scope of “accessory” Obtain CE mark for accessory under new
regime
Obtain CE mark for accessory under
new regime
Check if custom device is still custom device under new definition Obtain CE mark if changed to regular medical
device
Products specifically intended for the cleaning, disinfection or
sterilisation of medical devices and devices for the purpose of
control or support of conception will be considered medical
devices. Make gap assessment for information required for CE
marking of devices concerned.
Develop and implement transition strategy for
devices concerned into CE marking, generate
information needed for CE marking.
Obtain CE mark for devices
concerned under new regime.
Standalone software is no longer classified as active medical
device: revisit classification of software currently on the market as
medical device and make gap assessment for additional technical
file requirements for software classified in higher risk class.
Amend technical files for software in
accordance with requirements for higher risk
class, have software CE marked by notified
body if class IIa or higher.
Apply classification rules for new
software
ANNEX XV
LIST OF GROUPS OF
PRODUCTS WITHOUT
AN INTENDED
MEDICAL PURPOSE
· Identify Annex XV candidate devices in company’s portfolio
· Watch for Common Specifications becoming available for devices concerned
· Start building up technical documentation and if necessary QMS
· CE mark Annex XV devices using
Common Specifications

13. Each IVD currently on the market
must be transitioned in new
system
• Check if instrument or product is still or becomes (part of) an IVD
• under amended definition of IVD
• under amended definition of accessory
• under new definition of companion diagnostic
• under new definition of kit

14. Definitions IVDR
Subject Before entry into force During After
Chapter I Definitions Article 2 (2) contains a new definition:
'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 process or state;
– concerning a congenital abnormality;
– 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.
Categorize existing devices and determine if they are in or out of
scope of IVDR
Decide whether to CE mark new IVDs under IVDD,
IVDR or neither depending on whether they are in
scope for directive and/or regulation.
CE mark new IVDs under IVDR if in scope
The IVDR Regulation shall not apply to (article 1 (2):
(a) products for general laboratory use or research-use only
products, unless such products, in view of their characteristics, are
specifically intended by their manufacturer to be used for in vitro
diagnostic examination;
(b) invasive sampling devices or those which are directly applied to
the human body for the purpose of obtaining a specimen;
(c) higher metrological order internationally certified reference
materials.;
(d) materials used for external quality assessment schemes;
Categorize existing devices and determine if they are in or out of
scope of IVDR
Decide whether to CE mark new IVDs under IVDD,
IVDR or neither depending on whether they are in
scope for directive and/or regulation.
CE mark new IVDs under IVDR if in scope
Check if devices fall in enlarged scope of “accessory” Obtain CE mark for accessory under new regime Obtain CE mark for accessory under new
regime
Check if custom device is still custom device under new definition Obtain CE mark if changed to regular medical device
Categorize existing IVDs to check if in scope of ‘device for near
patient testing’ or ‘device for self-testing’ or ‘companion diagnostic’ to
determine future conformity assessment procedure
Check if IVD constitutes a ‘device for near patient
testing’ or ‘device for self-testing’ or ‘companion
diagnostic’, to which a specific conformity
assessment procedure applies.
Check if IVD constitutes a ‘device for near
patient testing’ or ‘device for self-testing’ or
‘companion diagnostic’, to which a specific
conformity assessment procedure applies.
Categorize existing IVDs to check if in scope of definition of ‘single
use device’ or ‘kit’ to determine impact on labelling and UDI
requirements
Check if IVD is in scope of definition of ‘single use
device’ or ‘kit’ to determine impact on labelling and
UDI requirements
Check if IVD is in scope of definition of
‘single use device’ or ‘kit’ to determine
impact on labelling and UDI requirements
Assess parallel trade procedure in article 14 and draft
procedure/policy for dealing with parallel trader requests to sign off
on amended labelling and/or packaging (article 14).
Apply procedure/policy for parallel trade label and/or
packaging signoff requests
Apply procedure/policy for parallel trade
label and/or packaging signoff requests

15. Chapter II – Making available of
devices, obligations of economic
operators, reprocessing, CE
marking, free movement

16. Supply chain controls
Manufacture
r
Importer Distributor
End
User
Post market surveillance and vigilance
Regulatory compliance of device
Verify compliance Verify compliance
Supplier
Unannounced NB
inspections

17. Making available & obligations
MDRChapter II Making
available of devices,
obligations of economic
operators, reprocessing,
CE marking, free
movement
Assess potential effect of reprocessing and
home brews under new hospital produced (so
called ‘home brew’) devices rules on company
business model
Monitor compliance of hospitals with
reprocessing and home brews under new
hospital produced devices rules
Monitor compliance of hospitals
with reprocessing and home brews
under new hospital produced brew
devices rules (task of national
authorities)
Manufacturers must establish, execute,
maintain and document a system for risk
management as described in Section 1a in
Annex I
Manufacturers must conduct a clinical
evaluation in accordance with the
requirements set out in Article 49 and
Annex XIII, including post-market clinical
follow-up.
Assess medical devices provided as service via
internet (article 5)
CE mark device as service under new
regime
Assess Own Brand Labelling consequences of
the requirements that a full technical file must be
present at each manufacturer (Article 8(4)).
Change business and certification setup
into virtual contract manufacturing, or get all
required contracts to access key
documentation from OEM in place.
Review new manufacturer responsibilities and
make gap assessment against QMS
Amend and implement amended QMS;
apply QMS optionally to devices placed on
the market in transitional period
Apply amended QMS
Make gap assessment against new recall
requirements (article 8 (8); amend procedures
and distribution agreements – adopt new [8a.
Manufacturers shall have a system for reporting
of incidents and field safety corrective actions as
described in Article 61.
Make gap assessment against new QMS criteria
in article 8 (5); amend procedures
Implement amended QMS; consider
revising directly into new ISO 13485:201x at
the same time
Art. 8 (13) mandatory insurance for product
liability: monitor developments
Purchase and maintain relevant insurance Maintain relevant insurance
New authorised representative (AR)
requirements article 9-10 – amend AR
agreement and procedures – expect AR
renegotiations or AR to cease activities if liability
requirements are adopted
Ensure continued access to AR services
when relevant

18. Making available & obligations
MDR
Review autonomous general obligations
of importers and distributors (articles 11-
12, e.g. verify compliance of the device,
inform competent authority of non-
compliance of the device and implement
corrective action) and amend contracts
accordingly
Implement SOPs, amend agreements in supply
chain
Select and mandate candidate for
person responsible for regulatory
compliance (art. 13)
Make and keep available in the organisation a
person responsible for regulatory compliance;
ensure training and where appropriate take out
personal liability insurance
Keep available in the organisation a
person responsible for regulatory
compliance
Prepare for new relabelling / repackaging
regime (art. 14),– draft SOP for new
regime
Implement and apply SOP Apply SOP
New regime for reprocessing (art 15) –
design traceability that can show if an
incoming complaint is about a new or
reprocessed single use device.
· Determine what Member States will allow
reprocessing
· Implement traceability that can show if an
incoming complaint is about a new or
reprocessed single use device.
· Ensure any reprocessing is resulting in
patient safety to stay on level of first time
use
Ensure any reprocessing is resulting
in patient safety to stay on level of first
time use
Continue to monitor changed
allowance per country
Implant card (art 16 + implementing acts) Define system of implant cards, or alternative
allowed systems
Declaration of conformity model (art 17
annex III) – check for gaps against
current model used
Amend existing DoC’s upon transfer per
product (group) into the new requirements
aligned with transfer plan agreed with notified
body.
Use MDR provided model of DoC
Parts manufacturers to ensure that the
part does not adversely affect the safety
and performance of the device. (art 21)
Parts manufacturers must generate supporting
evidence for this. Supporting evidence shall be
kept available to the competent authorities of
the Member States.
Parts manufacturers to generate
supporting evidence for each new part
placed on the market and to be kept
available to the competent authorities
of the Member States.

19. Making available & obligations
IVDR

20. Making available and obligations
IVDR

21. Chapter III – Identification and
traceability of devices, registration
of devices and of economic
operators, summary of safety and
clinical performance, European
databank on medical devices

22. The Eudamed “cathedral”
• Will Eudamed realistically be
ready to support
• all these functions
• in time?
“Who knows where the road
may lead us, only the fool
would say
Who knows if we'll meet along
the way
Follow the brightest star as far
as the brave may dare
What will we find when we get
there”
[Alan Parsons Project – La
Sagrada Familia]
OR

23. Eudamed future

24. MDR/IVDR and Eudamed
• Eudamed will contain integrated electronic systems on
• European UDI
• Registration of devices and economic operators
• Scrutiny applications (possibly other conformity assessments)
• Certificates issued by notified bodies
• Clinical investigations
• Vigilance
• Market surveillance activities
• Registration of subsidiaries and subcontractors of notified bodies
• A large part of the information in Eudamed will become publicly available
in accordance with the provisions regarding each part of the electronic
system
• Will “do away with diverging national registration requirements which
have emerged over recent years and which have significantly increased
compliance costs for economic operators. It will therefore also contribute
to reducing the administrative burden on manufacturers.”

25. Traceability, registration, Eudamed
MDR and IVDR
Chapter III
Identification and
traceability of devices,
registration of devices
and of economic
operators, summary of
safety and clinical
performance,
European databank on
medical devices
UDI (art 23 (1) MDR / 21 (1) IVDR) Distributors and
importers shall co-operate with the manufacturer or
authorized representative to achieve an appropriate level
of traceability of devices. – implement changes to
distribution agreements
implement changes to distribution agreements
and SOPs
Article 23 (2) MDR / 21 (2) IVDR: For devices, other than
custom-made or investigational devices, economic
operators shall be able to identify the following to the
competent authority, for the period referred to in Article
8(4):
(a) any economic operator to whom they have supplied a
device;
(b) any economic operator who has supplied them with a
device;
(c) any health institution or healthcare professional to
whom they have supplied a device. – implement and
improve traceability
Get traceability systems in place in supply
chain, where possible based on UDI
Article 24 (3) MDR / 22 (3) IVDR assign UDI to device
and higher levels of packaging and (24 (4)) place that on
the label and higher levels of packaging and (24a-c + (5))
keep UDI administration for reporting and tech file.
Choose type of UDI system to be applied, in
line with global requirements towards UDI
If possible, manufacturers may (Article 24b
MDR / 22b IVDR) apply new process for
registration of devices prior to placing on the
market
Apply new process for registration of
devices prior to placing on the market
(Article 24b MDR / 22 b IVDR)
When implemented, companies may apply
process for registration of manufacturers, and
authorised representatives and importers, to
obtain a single registration number to identify
them for the purposes of UDI and traceability.
Apply process for registration of
manufacturers, authorised
representatives and importers, single
registration number (Article 25a)
Identify information that must be reflected in summary of
safety and performance for each device and conceive
plan for generating summaries for each class III and
implantable device (article 26).
Execute plan for producing summaries for each
device. Make available summaries for
implantable and class III certified under MDR
(Article 26 MDR / 25 IVDR)
Draw up and make available summary
of safety and clinical performance for
class III and implantable devices,
other than custom-made or
investigational devices (Article 26
MDR / 25 IVDR)
If available: Article 27 MDR / 25 IVDR – enter
data into EUDAMED
Article 27 / 25 IVDR – enter data into
EUDAMED

26. Traceability, registration, Eudamed

27. Chapter IV – Notified bodies

28. Notified bodies
• Stronger supervision on Notified Bodies
• Continuation of joint assessment; handbook transcribed into NB annex in
MDR
• Scrutiny on high risk devices
• Thorough testing and regular checks on manufacturers
• Unannounced factory inspections
• Rotation of notified body staff involved in assessment
• Adoption of common technical specifications
• Notified Body numbers continue to drop
• Resources will become critical in transition

29. Most important for manufacturer
• Article 29-31: Requirements relating to Notified Bodies
• All Notified Bodies must be re-designated
• Joint Assessment
• Article 42: Conformity Assessment Procedure
• Unannounced Audits and testing of samples
• Article 44: Mechanism for scrutiny of certain conformity assessments
• For class III products and implants
• Peer-review of an expert panel on an European level
• Article 60: Post-market surveillance system of the manufacturer
• Periodic post-market surveillance reports for class III products and
implants
• Reviewed by Notified Body and make available to Competent
Authorities

30. Most important for manufacturer
• Annex IIa: Technical Documentation on post-market surveillance
• Establish post-market surveillance plan
• Periodic safety update report reviewed by Notified Body and
available to CA
• Annex VI Requirements to be met by Notified Body
• Pay particular attention to clinical data from post-market surveillance
and PMCF activities undertaken since the previous (re-)certification
• Annex VIII Conformity Assessment
• The Notified Body shall randomly perform unannounced on-site
audits
• The Notified Body shall employ device reviewers with sufficient
clinical expertise, including the use of external clinical expertise
• Procedure on scrutiny for class III products and implants
• Annex XIII Clinical Evaluation and Post-Market Clinical Follow-up
• Annex XV List of Groups of Products without an intended medical
purpose
• e.g. dermal fillers, fat removing devices or lasers for hair removal

31. Notified bodies

32. Chapter V – Classification and
conformity assessment

33. MDR: conformity assessment
issues
• Re-/up classification of devices (e.g. substance based, implants)
• Resources?
• Scrutiny procedure (an expert panel should assess several hundred
devices per year within 60 days)
• PSURS and trend reporting
• Special conformity assessments procedures for substance based
MD
• Reporting and planning obligations of member states to Commission
• Problematic
• Liability and insurance for manufacturers and Authorized
Representatives

34. MDR conformity assessment
routes overview

35. IVDR: quantum leap
• IVDs did not feature prominently in political discussion around new
medical devices regulations, but immense changes in the works
• IVDs for ‘indirect medical purpose’ (“life style tests”) likely to be
regulated
• Genetic testing requirements
• Radical changes in conformity assessment / market access

36. Classification
Currently the ‘doesn’t fit in
a specific rule’ class is
self-certified, under IVDR
notified body certified
Only remaining self
certification

37. IVDRs classification change

38. IVDR conformity assessment

39. IVDR conformity assessment
process

40. Classification and conformity
assessment MDR

41. Classification and conformity
assessment MDR

42. Classification and conformity
assessment MDR

43. Classification and conformity
assessment IVDR

44. Classification and conformity
assessment IVDR

45. Classification and conformity
assessment IVDR

46. Chapter VI – Clinical evaluation
and clinical investigations

47. Clinical requirements
• MDR proposal is about “More Data, Really”
• Chapter VI: Clinical evaluation and clinical investigations: article 49 –
60
• Annex XIII (Part A): CLINICAL EVALUATION
• Annex XIII (Part B): POST-MARKET CLINICAL FOLLOW-UP
• Annex XIV: CLINICAL INVESTIGATIONS
• Relation to current and future ISO 14155 standard problematic
• MDR will likely not be in line with global state of art in medical
devices GCP

48. Clinical requirements – MDR
chapter VI
• Article 49: Clinical evaluation
• Article 50: General requirements regarding clinical investigations
• Article 51: Application for clinical investigations
• Article 52: Registration of clinical investigations
• Article 53: Electronic system on clinical investigations
• Article 54: Clinical investigations with devices authorised to bear the CE
marking
• Article 55: Substantial modifications to a clinical investigation
• Article 56: Information exchange between Member States
• Article 57: Information by the sponsor in the event of temporary halt or
termination of a clinical investigation
• Article 58: Clinical investigations conducted in more than one Member
State
• Article 59: Recording and reporting of events occurring during clinical
investigations
• Article 60: Implementing acts

49. Clinical requirements
• MDR will
• elaborate on the current clinical investigation requirements in
Article 15 MDD and Annex X, and align the MDR with the clinical
trials regime for medicinal products
• propose system for clinical investigations similar to the current
system for medicinal products including notification in a
centralized database
• member state authority assessment of clinical investigations – the
EP proposes to have this done by ethics committees.
• make Post-Market Clinical Follow-up (PMCF) mandatory as part
of the clinical evaluation cycle for the device concerned,
essentially implementing the PMCF MEDDEV (MEDDEV 2.12/2
rev. 2)
• There will be more attention for clinical benefit and efficacy
(defined in article 2 (37d) and (37e)) and effectiveness (article 2
(37f)

50. Clinical requirements
• Important concepts have been introduced that are inconsistent with the
current Good Clinical Practice standard for medical devices, the MDD
harmonized EN ISO 14155:2011 (e.g. proposed definition of ‘sponsor’
under the MDR is far wider than under EN ISO 14155:2011)
• Not clear at this moment if and how the EU legislation will reconcile the
proposal with the GCP standard
• At this point it is safe to say that requirements for clinical evidence will
increase substantially and will require significantly higher investment
from companies.
• In order to design, work with and interpret clinical studies companies will
need to invest in staff who are knowledgeable in
• Regulatory affairs,
• Good Clinical Practice (GCP) and
• Clinical investigation
• Meet the requirement of having a person responsible for regulatory
compliance

51. Clinical – clinical evaluation
• Prepare with MEDDEV 2.7/1 rev 4 (underway – not published yet)
• Annual mandatory update for implantables and class III devices!

52. Clinical MDR

53. IVDR: performance evaluation and
performance studies
• Performance evaluation mandatory
• A performance evaluation shall follow a defined and methodologically
sound procedure for the demonstration of the following, in accordance
with the principles set out in this Article and with Annex XII:
(a) scientific validity;
(b) analytical performance;
(c) clinical performance.
The data and conclusions drawn from the assessment of these
elements shall constitute the clinical evidence for the device. The
clinical evidence shall scientifically demonstrate that the intended
clinical benefit(s) and safety will be achieved according to the state of
the art in medicine.
• post-market performance follow-up plan mandatory, for class C and D
yealry updates required

54. Performance studies
• More clinical data required for conformity assessment of IVDs
• “As a general rule, clinical evidence should be sourced from clinical
performance studies to be carried out under the responsibility of a
sponsor taking responsibility for the clinical performance study.”
• Regime for interventional performance studies
• where invasive sample taking is done only for the purpose of the
performance study
• where it concerns an interventional clinical performance study
• where the conduct of the study involves additional invasive
procedures or other risks for the subjects of the studies
• in case of performance studies involving companion diagnostics
• Clinical performance studies data not commercially sensitive data

55. Performance studies
• Scientific and ethical approval necessary for performance studies
• Member state agency assesses scientific aspects
• Ethics committee assesses ethical aspects

56. Clinical IVDR

57. Chapter VII – Post-market
surveillance, vigilance and market
surveillance

58. Post-market surveillance
• Manufacturer must implement post market surveillance system as part of
the post market surveillance plan:
(a) to update the benefit risk determination and risk management, the
design and manufacturing information, the instructions for use and the
labelling;
(b) to update the performance evaluation;
(c) to update the summary of safety and performance;
(d) for the identification of needs for preventive, corrective or field
safety corrective action;
(e) for the identification of possibilities to improve the usability,
performance and safety of the device;
(f) when relevant, to contribute to the post-market surveillance of other
devices;
(g) to detect and report trends
• Manufacturer must make annual PSUR per device or group

59. Vigilance
• Report electronically:
(a) any serious incident involving in respect of devices made available
on the Union market, except expected erroneous results which are
clearly documented and quantified in the product information and in
the technical documentation and are subject to trend reporting
pursuant to Article 59a;
(b) any field safety corrective action in respect of devices made
available on the Union market, including any field safety corrective
action undertaken in a third country in relation to a device which is
also legally made available on the Union market, if the reason for
the field safety corrective action is not limited to the device made
available in the third country.
• Implementation of EU electronic system for vigilance to be used by
Commission and authorities

60. Market surveillance
• Central EU surveillance policy that member states must fit their national
surveillance plans in
• New procedures to cooperate between member states and Commission
in case of IVDs that are public health risk or non-compliance
• Electronic system on market surveillance will be set up

61. Vigilance and market surveillance
• Advantages
• EU-established binding standard procedures
• Disadvantages
• Expected that many member states will not be able to commit the
resources that the implementation of the vigilance and market
surveillance procedures will require for lack of political sense of
urgency
• Preparation
• Companies will need to review their internal vigilance and post-
market surveillance processes to prepare to scale for the increased
reporting requirements

62. Post market

63. Chapter VIII – Cooperation
between member states, Medical
Device Coordination Group, expert
panels and device registers

64. Governance
• Due to the fact that the MDCG will not be able to work like the CMC or
the current CAMD there will be the great risk of un-harmonized
implementation

65. Governance

66. Chapter IX – Confidentiality, data
protection, funding, penalties

67. Confidentiality, data protection,
funding, penalties
Chapter IX Confidentiality, data
protection, funding, penalties
· Prepare for new penalties regime
under MDR
· Prepare for market funded
surveillance

68. Chapter X – Final provisions
(transitional regime etc.)

69. No grandfathering
THERE IS NO GRANDFATHERING IN
THE EU !
• EU will require that all products on
the market are phased into the new
system by the end of transitional
period
• This mean that you have to do a new
conformity assessment under the
new rules for all devices currently on
the market or remove the product
from the market

70. Transition

71. Timeline MDR
Q3/4
2016
Adoption
of MDR
Q1/Q2
2017
Entry into
force
Q1/Q2
2020
End of
transition
period
MDR
Q1/Q2 2022
Last
possible
granted
MDD
certificate
expires
Best current
prediction of
transitional regime
71
Certs
grace
period
Notified Bodies
reaccreditation
under MDR
Transition period of 3
years with Sunshine

72. Timeline
Q3/4
2017
Adoption
of IVDR
Q1/Q2
2017
Entry into
force
Q1/Q2
2022
End of
transition
period
Q1/Q2 2024
Last
possible
granted
IVDD
certificate
expires
Transition period of 5
years with Sunshine
Best current prediction of transitional regime
Certs
grace
period
Notified Bodies
reaccreditation
under IVDR

73. Prepare!

74. www.axonlawyers.com
THANKS FOR YOUR ATTENTION
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Axon Lawyers
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@meddevlegal
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