Slides from the panel at the 2017 Advamed MedTech conference in San Jose about the new EU medical devices and IVD regulations

1. ADVAMED MDR AND
IVDR PANEL
Advamed EU MDR and IVDR panel
25 September 2017
Erik Vollebregt
www.axonadvocaten.nl

3. Your panel
Moderator:
• Erik Vollebregt, Axon Lawyers
Speakers:
• Oliver Bisazza, Director Industrial Policy and Regulations, MedTech
Europe
• Ibim Tariah, Technical Director at BSI Americas Inc, BSI
• Jon L Lange, Principal Life Sciences, EY
• Hilde Viroux, Global EU MDR Compliance, Alcon

4. Some questions to
help you sleep better
• Who has a copy of the MDR or IVDR?
• Who has read it completely?
• Who understands it (sort of / completely)?
• Whose company has done a gap assessment?
• Whose company has done an impact assessment based on the
gap assessment?
• Whose company made a transition / implementation plan?
• Whose company has decided for each of its devices if it will
remediate, retire or replace it for the EU market?
• Whose department was allocated sufficient resources to
implement the transition plan?
• Whose company thinks it will complete transition in time?

5. No grandfathering and no moving
of implementation deadlines
• All devices on the market are phased
into the new system by the end of
transitional period
• This means 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
• If you don’t have a new CE under
MDR or IVDR, you cannot place new
product on the market after transition
period
• Do not count on the EU “having to
move deadlines because it will be
chaos”, as this would be
unprecedented

6. Copyright © 2012 BSI. All rights reserved. 6
IVDR Transition (Article 110)
Copyright © 2016 BSI. All rights reserved.
05 May 2017
Adoption of IVDR
Entry in to Force
25 May 2017
NBs designation
under IVDR
Date of Application
26 May 2022
IVDD certificate
validity (2 years )
IVDD certificates can be issued/re-issued/renewed
IVDR certificates
Transition period
5 years
No more « making
available or putting
into service » of
devices covered by
IVDD certificates
IVDD certificates void
27 May 2024
27 May 2025
NBs can apply for
designation
26 Nov 2017

7. Copyright © 2012 BSI. All rights reserved. 7
Transition timelines MDR (Article 120)
25 May 2017
Entry into Force
NB designation under MDR
26 May 2020
Date of Application
all MDD/AIMD certificates void
MDD/AIMD « grace period »
4 years
MDD/AIMD certificates
MDR certificates
Transition period
3 years
Annex IV/ 6 certificates void No more « placing on
the market » of devices
covered by MDD/AIMD
certificates
Copyright © 2017 BSI. All rights reserved.
27 May 202527 May 2022
27 May 2024

8. Copyright © 2012 BSI. All rights reserved. 8
Transition timelines MDR (Article 120)
25 May 2017
Entry into Force
NB designation under MDR
26 May 2020
Date of Application
all MDD/AIMD certificates void
MDD/AIMD « grace period »
4 years
MDD/AIMD certificates
MDR certificates
Transition period
3 years
Annex IV/ 6 certificates void No more « placing on
the market » of devices
covered by MDD/AIMD
certificates
Copyright © 2017 BSI. All rights reserved.
27 May 202527 May 2022
27 May 2024
PMS, market surveillance, vigilance, registration of
economic operators and of devices according to MDR
Only if no significant
changes in design and
intended purpose.

9. Page 9
Critical considerations
Each product/product family across the portfolio will be implicated and
additionally aspects of your Operating model may need to be modified.
► Each product/family can be implicated differently. .
► Implementation will have to be conducted for all products
► Assessment needs to be conducted under each change element in the new Legislation, implementation needs to be
planned holistically due to interdependencies in remediation eg ( RS, Clinical, Tech File, Labelling)
Product change impacts
Regulatory
• Technical Files / GSPR
• Labelling/ DoC / IFU/UDI
• Up classification/Classification
• Re-processing
• Scrutiny
Labelling
• UDI
• Implant Cards
• IFU/DFU
• Medical device symbol
Clinical
• CER/PER
• PMCF
Product Design/Dev
• Restricted Substances
Operating Model change impacts
PMS
• Complaint Handling process capability
• Vigilance reporting/PSUR
Supply Chain
• UDI system technology
• SC traceability system
Quality Assurance
• QMS/Re-certification
• Notified Body
Regulatory
• Re-registration
• PRRC
• Economic Operator compliance

10. Page 10
Holistic implementation approach
Strong governance for a controlled implementation of key elements
The planning of the implementation is driven by:
► Recertification of the QMS
► Reregistration audit cycle
► Availability of resources/ capacity – Clinical Evidence & Notified Bodies
► Commercial prioritization
Key elements of the implementation are:
A. Product remediation (through remediation playbook)
B. Business operating model (through deployment playbook)
C. Business continuity, sustainability, and NPD
Governance - These key elements are tracked and controlled by EPMO in the Implementation masterplan
Governance
QMS
recertification
B. Business Operating Model Remediation
A. Product Remediation
C. Business
Continuity
Commercial Prioritization