Informa Eudamed update 29 january 2014

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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

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Informa Eudamed update 29 january 2014

  1. 1. EUDAMED KEY CHANGES AND IMPACT ON INDUSTRY Informa Medical Devices Directives & Revision 29 January 2014 Erik Vollebregt www.axonlawyers.com
  2. 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. 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. 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. 5. The Eudamed “cathedral” Source: Jacques Thielen, Medtronic
  6. 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. 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. 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. 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. 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. 11. Special notified bodies
  12. 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. 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. 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. 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. 16. Vigilance • Parliament: • Manufacturers report any incident in Eudamed • CAs file all suspected serious incidents reported by patients and HCP in Eudamed
  17. 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. 18. Electronic system on vigilance • Access
  19. 19. Electronic system on vigilance • Distribution of information
  20. 20. Electronic system on vigilance
  21. 21. Transmission of information to Market surveillance
  22. 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. 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. 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. 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.

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