1. EU UDIPERSPECTIVERAPS conference29 September 2014Erik Vollebregtwww.axonlawyers.com

2. Agenda Policy Recommendation New RegulationsUDI: The forever project 3. Policy We look at what theUS does We harmonise viainvolvement in IMDRF Improving vigilanceand marketsurveillance is a bigmotivator We try to make surethat the MemberStates do not getahead of themselvesin view of the Revisionof the directives We will implementsomething staged inthe new regulations 4. PolicyIn 2010, the European Commission set up a European UDI ad hoc WorkingGroup, within the regulatory framework established by the directives onmedical devices, in order to develop a coordinated approach, taking intoaccount the progress made at both national and international level.Threefold goal:1. encourage contributions and monitor the reaction of CompetentAuthorities to the work carried out at international level;2. encourages the sharing of views and information on national initiativesdeveloped by Member States and search for common solutions;3. facilitate the convergence with the future Union legislation of nationalinitiatives 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 devicedirectives while it is addressed in some cases at national and/orregional level. The differences and incompatibility between thetraceability mechanisms may weaken and compromise theefficiency of the systems put in place. In addition, the development of different national and/or regionalunique device identification mechanisms would obligemanufacturers to adapt their products to each mechanism in orderto fulfil traceability obligations. This Recommendation does not aim to define all the aspects ofthe UDI system. It should be taken as a tool to facilitate thecompatibility of the traceability mechanisms established atnational and/or regional level and to pave the way to themandatory implementation of an internationally compatible UDIsystem of the Union. 6. EU recommendation on UDITies 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 authoritiesLatest on Joint Action plan in recent SWD: 7. New Regulations Placeholder in regulation for gradual implementation plus total relianceon Eudamed database Following a risk-based approach, implementation of the UDI systemshall 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 correctiveactions included in the implant card 8. NewRegulations Article 24 on UDI Aim = global coherence UDI consisting of device and production identifier on label Commission designates one or more entities to operate UDIsystem Commission designates devices, categories or groups of devicesfor UDI Economic operators and health institutions store and keep, byelectronic means, the device identifier and the production identifierof the devices Commission regulates details by delegated act Annex V part B Data elements for the product identifier 9. New Regulations: UDI in thesupply 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 withArticle 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 CEmarking Declaration of Conformity (Annex III (3)) must contain The UDI device identifier as referred to in item (i) of point (a) ofArticle 24(1) as soon as identification of the device that is coveredby 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) ofArticle 24(1) attributed by the manufacturer to the device inquestion, as soon as identification of this device shall be based ona UDI system, or otherwise clear identification by means ofproduct code, catalogue number or other unambiguous referenceallowing traceability; 11. New regulations: knownunknownsCommission can adopt delegated acts(a) determining the devices, categories or groups of devices whoseidentification shall be based on the UDI system and the timelines forimplementing this.(b) specifying the data to be included in the production identifier which,following a risk based approach, may vary depending on the risk classof the device;(c) defining the obligations of economic operators, of health institutions andof professional users, in particular regarding allocation of the numeric oralphanumeric characters, placement of the UDI on the label, storage ofinformation in the electronic system on UDI and use of the UDI indocumentation and reporting related to the device provided for in thisRegulation;(d) amending or supplementing the list of information set out in Part B ofAnnex V in the light of technical progress. 12. New regulations: knownunknowns Delegated act necessary, BUT No formal obligation to adopt it With the difficult process of the Revision, no draft delegated actson 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 andcommunication (e.g. for purpose of field actions) Revisit existing contracts / futureproof new contracts 14. THANKS FOR YOUR ATTENTIONErik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 47 180 683Eerik.vollebregt@axonlawyers.com@meddevlegalB http://medicaldeviceslegal.comREAD MY BLOG:http://medicaldeviceslegal.comwww.axonlawyers.com