This document summarizes the EU's policy and regulations around implementing a Unique Device Identification (UDI) system for medical devices. It discusses how the EU is harmonizing its approach with the US and international standards. The new Medical Device Regulations include provisions for a staged implementation of UDI labeling beginning with higher risk devices. Key unknowns remain around how the UDI system database will operate and what requirements will be set in delegated acts to specify UDI data elements and stakeholder obligations.

1. EU UDI
PERSPECTIVE
RAPS conference
29 September 2014
Erik Vollebregt
www.axonlawyers.com

2. Agenda
• Policy
• Recommendation
• New Regulations
UDI: “The forever project”

3. Policy
• We look at what the
US does
• We harmonise via
involvement in IMDRF
• Improving vigilance
and market
surveillance is a big
motivator
• We try to make sure
that the Member
States do not get
ahead of themselves
in view of the Revision
of the directives
• We will implement
something staged in
the new regulations

4. Policy
In 2010, the European Commission set up a European UDI ad hoc Working
Group, within the regulatory framework established by the directives on
medical devices, in order to develop a coordinated approach, taking into
account the progress made at both national and international level.
Threefold goal:
1. encourage contributions and monitor the reaction of Competent
Authorities to the work carried out at international level;
2. encourages the sharing of views and information on national initiatives
developed by Member States and search for common solutions;
3. facilitate the convergence with the future Union legislation of national
initiatives developed by Member States.

5. EU Recommendation on UDI
• Goal: make sure member states do not prejudice future acquis in UDI:
• “Traceability is currently not regulated by the medical device
directives while it is addressed in some cases at national and/or
regional level. The differences and incompatibility between the
traceability mechanisms may weaken and compromise the
efficiency of the systems put in place.”
• “In addition, the development of different national and/or regional
unique device identification mechanisms would oblige
manufacturers to adapt their products to each mechanism in order
to fulfil traceability obligations.”
• “This Recommendation does not aim to define all the aspects of
the UDI system. It should be taken as a tool to facilitate the
compatibility of the traceability mechanisms established at
national and/or regional level and to pave the way to the
mandatory implementation of an internationally compatible UDI
system of the Union.”

6. EU recommendation on UDI
Ties into the Joint Action Plan objectives of
• Improvement of incident reporting
• Efficient recalls and other field safety corrective actions
• Efficient post market actions by national competent authorities
Latest on Joint Action plan in recent SWD:

7. New Regulations
• Placeholder in regulation for gradual implementation plus total reliance
on Eudamed database
• “Following a risk-based approach, implementation of the UDI system
shall be gradual, starting with devices falling in the highest risk class;”
• Not for custom-made and investigational devices
• To be
• used for reporting serious incidents and field safety corrective
actions
• included in the implant card

8. New
Regulations
• Article 24 on UDI
• Aim = global coherence
• UDI consisting of device and production identifier on label
• Commission designates one or more entities to operate UDI
system
• Commission designates devices, categories or groups of devices
for UDI
• Economic operators and health institutions store and keep, by
electronic means, the device identifier and the production identifier
of the devices
• Commission regulates details by delegated act
• Annex V part B – Data elements for the product identifier

9. New Regulations: UDI in the
supply chain
• Article 24 Manufacturer must set up UDI for a device
• Article 11 (2) (e) and (f) - importer must verify that
• the device is labelled in accordance with this Regulation and
• UDI has been assigned by the manufacturer in accordance with
Article 24.
• Article 12 (2) (c) - distributor must verify that the manufacturer and,
where applicable, the importer have complied with the UDI requirements

10. New regulations: UDI and CE
marking
• Declaration of Conformity (Annex III (3)) must contain
• The UDI device identifier as referred to in item (i) of point (a) of
Article 24(1) as soon as identification of the device that is covered
by the declaration shall be based on a UDI system;
• Tech file (Annex II (1.1) (b) must contain
• the UDI device identifier as referred to in item (i) of point (a) of
Article 24(1) attributed by the manufacturer to the device in
question, as soon as identification of this device shall be based on
a UDI system, or otherwise clear identification by means of
product code, catalogue number or other unambiguous reference
allowing traceability;

11. New regulations: known
unknowns
Commission can adopt delegated acts
(a) determining the devices, categories or groups of devices whose
identification shall be based on the UDI system and the timelines for
implementing this.
(b) specifying the data to be included in the production identifier which,
following a risk based approach, may vary depending on the risk class
of the device;
(c) defining the obligations of economic operators, of health institutions and
of professional users, in particular regarding allocation of the numeric or
alphanumeric characters, placement of the UDI on the label, storage of
information in the electronic system on UDI and use of the UDI in
documentation and reporting related to the device provided for in this
Regulation;
(d) amending or supplementing the list of information set out in Part B of
Annex V in the light of technical progress.

12. New regulations: known
unknowns
• Delegated act necessary, BUT
• No formal obligation to adopt it
• With the difficult process of the Revision, no draft delegated acts
on the horizon yet

13. And there is more
• Manage EU data protection aspects of processing of personal (health)
data in relation to UDI
• Special attention to extra-EU export of personal data
• Implement supply chain arrangements relating to UDI compliance and
communication (e.g. for purpose of field actions)
• Revisit existing contracts / futureproof new contracts

14. 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
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