Presentation at the 29-30 January 2014 Informa Medical Devices Revision conference in Brussels regarding developments in relation to the Eudamed database and its rule in the new EU medical devices system

1. EUDAMED KEY
CHANGES AND
IMPACT ON INDUSTRY
Informa Medical Devices Directives & Revision
29 January 2014
Erik Vollebregt
www.axonlawyers.com

2. Objectives
• What is planned in regards to enhancements to the Eudamed database?
• How will the database be operated?
• Assessing how the database will change the way of working from an
industry perspective once finalised
• Examining the key challenges that will come with the database

3. The ghost of Eudamed past and
present
Conclusions:
• Eudamed is useful
BUT
• Very slow
• Not user friendly
• Member states often lack
IT resources to effectively
use Eudamed and many
will not have them ready
soon
• Eudamed does not deliver
in market surveillance
• Information in Eudamed is
limited, incomplete, insuffi
cient

4. The ghost of Eudamed past and
present
“Structural Problems with Eudamed and proposed changes in the Revision
of the Medical Device Legislation”
•
•
•
•
•
No complete overview of actors and devices on the EU market
No sufficiently coherent rules as to the detail of registration data
No public transparency
CAs do not have the resources to enter data
Data ownership rules make database difficult to work with
BUT
• Direct data entry by huge number of parties
• Public transparency
• UDI accommodation
WILL ALL BE NO PROBLEM

5. The Eudamed “cathedral”
Source: Jacques Thielen, Medtronic

6. The Eudamed “cathedral”
• Will Eudamed realistically be
ready to support
• all these functions
• in time?
OR
“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]

7. MDR revision
• Eudamed will contain integrated electronic systems on
•
•
•
•
•
•
European UDI
Registration of devices and economic operators
Certificates issued by notified bodies
Clinical investigations, on vigilance and on market surveillance
Registration of subsidiaries and subcontractors of notified bodies
Special 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.”

8. MDR revision
• Access
• Member states and Commission: unlimited access
• Rest (NoBos, economic operators, sponsors, HCPs and patients) on
need to know basis
• Development & management
• Commission lays down modalities necessary for the development
and management of Eudamed in implementing acts

9. Supply chain / UDI
• UDI system to be set up by Commission, in cooperation with the Member
States, to collate and process information to describe and identify the
device and to identify the manufacturer and, where applicable, the
authorised representative and the importer; details in Annex V.
• Importers shall ensure that the device is registered in the electronic
system for UDI – every chain checks compliance of previous one
• Commission takes delegated acts to fill in details

10. Notified bodies
• Subsidiaries and subcontractors publicly accessible in Eudamed:
• Information on notification of NoBo plus assessment reports joint
assessment team and MDCG recommendation: publicly available
• Changes to notification of NoBo in Eudamed: not certain if public (art. 36
(5) last par)

11. Special notified bodies

12. Notified bodies
• Certificates and related information in Eudamed
• System will collate and process information on certificates issued by
notified bodies
• Notified body enters information regarding certificates
• Issued (including amendments and supplements)
• suspended, reinstated, withdrawn or refused certificates and
• restrictions imposed on certificates.
• Accessible to the public

13. Clinical investigations
• Eudamed assigns clinical investigation numbers for application to system
• Sponsor registers article 52 prescribed details into system regarding the
clinical investigation prior to start
• Any changes to investigation must be entered into Eudamed within a
week
• “Upon completion of the clinical investigation, the sponsor shall enter
in the electronic system a summary of its results drawn up in a way
that is easy for a lay person to understand.”
• All clinical investigation information that must be entered is completely
accessible to the public, unless confidentiality exception applies
(implementation of exception not described)

14. Clinical investigations
• System will collate and process:
(a) the registration of clinical investigations and associated details to
be provided;
(b) the exchange of information between the Member States and
between them and the Commission regarding refusal, suspension,
termination and withdrawals of applications;
(c) the information related to clinical investigations conducted in more
than one Member State in case of a single application in multiple
member states;
(d) reports on serious adverse events and device deficiencies in case
of a single application in multiple member states
(da) the clinical investigation report and summary submitted by the
sponsor in case of early termination
• Plus: Annex XIII part B sub 1: PMCF clinical data

15. Clinical investigations
• Commission must
• build Eudamed as to be compatible with EudraCT
• Implement HCP and public access to authorised parts
• HCPs: full access
• Public: reports on serious adverse events and device
deficiencies and the clinical investigation report and summary
submitted by the sponsor
• Parliament:
• “Upon a reasoned request, all information on a specific medical
device available in the electronic system shall be made accessible to
the party requesting it, save where the confidentiality of all or parts of
the information is justified in accordance with Article 52(3).”
• Commission takes implementing acts re the functioning of the electronic
system

16. Vigilance
• Parliament:
• Manufacturers report any incident in Eudamed
• CAs file all suspected serious incidents reported by patients
and HCP in Eudamed

17. Electronic system on vigilance
• What’s in it?
(a) reports by manufacturers on serious incidents and field safety
corrective actions referred to in Article 61(1);
(b) periodic summary reports by manufacturers;
(c) HCP and patient reports by competent authorities on serious
incidents;
(d) reports by manufacturers on trends;
(da) the periodic safety update reports drawn up by manufacturers
(new proposed article 63a);
(e) field safety notices by manufacturers;
(f) information to be exchanged between the competent authorities of
the Member States and between them and the Commission.

18. Electronic system on vigilance
• Access

19. Electronic system on vigilance
• Distribution of information

20. Electronic system on vigilance

21. Transmission of
information to
Market surveillance

22. Market surveillance
• Measures against economic operators with non-compliant devices
presenting a risk to health and safety go in Eudamed
• In case of cross-border non-compliance member states shall
immediately inform the Commission and the other Member States of
the results of the evaluation and of the actions which they have
required the economic operators to take, by means of Eudamed
• National provisional measures to restrict device being made
available against economic operator that does not take adequate and
timely corrective action
• Information about the non-compliance of the device subject to the
above
• Preventative health measures against a device or a specific category or
group of devices go in Eudamed

23. Conclusion on the Eudamed cathedral
Will it be …
Will it be in time or way …
Will it get us …
Will we have a more transparent overview …
Will the Commission
be on the …
In the end …
BUT
• Will we even have a final regulation this year?
• It looks less and less likely that we will

24. THANKS FOR YOUR ATTENTION
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
READ MY BLOG:
http://medicaldeviceslegal.com
www.axonlawyers.com

25. Legal stuff
• The information in this presentation is provided for information purposes only.
• The information is not exhaustive. While every endeavour is made to ensure
that the information is correct at the time of publication, the legal position may
change as a result of matters including new legislative developments, new
case law, local implementation variations or other developments.
• The information does not take into account the specifics of any person's
position and may be wholly inappropriate for your particular circumstances.
• The information is not intended to be legal advice, cannot be relied on as
legal advice and should not be a substitute for legal advice.