Updated EU Medical Device Regula2ons: What s In, What s Out, and What s Hot?

Updated EU Medical Device Regula2ons: What s In, What s Out, and What s Hot?

Introduc2on

EU Medical Device Overview

Current Medical Device Direc2ves ü Governed by 3 directives (past 15-20 yrs):

Polling Ques2on #1

Current Medical Device Direc2ves ü US > FDA oversees all pharmaceuticals and medical devices ü EU > European Medicines Agency (EMA) for pharmaceuticals and Conformité Européenne (CE) marking for devices No centralized agency responsible for issuing CE marking Such marking not an authorization to sell a product Requirements for CE marking based on risk ü Notified Bodies standards vary; in general, relatively little data needed to obtain CE marking ü May 2011, EUDAMED established to share data regarding device certifications, clinical investigations, and safety surveillance; at present, EUDAMED not accessible to device manufacturers, healthcare providers, or the public

Need for Updated Direc2ves ü Current system for certification has 2 main strengths: Streamlined processes: Little difference between US and EU serious recalls: ü However, EU system criticized for inconsistencies in interpretation and in standards between Notified Bodies Several high-profile recalls of medical devices in the last few years Both the European Council and European Parliament have issued statements regarding need to update medical device directives to meet the needs of tomorrow and achieve a suitable, robust, transparent and sustainable regulatory framework

Need for Updated Direc2ves ü To that end, the European Commission has identified seven problems that should be addressed in any new legislation: Oversight of Notified Bodies Post-market safety Regulatory status of products Lack of transparency and harmonized traceability Access to external expertise Unclear and insufficient obligations and responsibilities of economic operators Management of the regulatory system

Polling Ques2on #2

Proposed Legisla2on ü September 2012, European Commission proposed legislation to modernize & expand medical device directives and update them to regulations ü Two separate but related documents: One covers medical devices and active implantable medical devices (combination of the current MDD and AIMDD directives) Another addresses in vitro diagnostic medical devices (similar to the current IVDD directive) For both directives, stated objectives are to: Ensure a high level of protection of human health and safety Ensure the smooth functioning of the internal [EU] market Provide a regulatory framework that is supportive of innovation and the competitiveness of the European medical device industry

Proposed Legisla2on

Parliamentary Review ü Proposed legislation under review; both regulations routed to the Committee on the Environment, Public Health, and Food Safety, but were assigned to different rapporteurs:

Looking to the Future ü Rapporteur reports released in April 2013, still in draft form, overall tone of the opinions unlikely to change ü Minor modifications required to in vitro diagnostic device directive; however, forward movement likely to be stopped until question of centralized device authority resolved ü Eucomed supports Commission s proposal to strengthen current Notified Bodies Stated that only the best Notified Bodies should be allowed to approve medical devices But, they ve expressed concern that switching to centralized system would drastically increase time it takes to get device to market in EU

Looking to the Future

Looking to the Future ü Are concerns well-founded? Amount of data likely to be required on higher-risk medical devices Conducting additional research does require time and money, although there does not appear to be an expectation for pharmaceutical-style trials involving large numbers of patients Concerns about delays during the review and approval process may be more difficult to substantiate if the approving bodies establish (and adhere to) fixed timelines If the EMA can review a new drug application in 270 days, then presumably any medical device could be adequately vetted in the same time period

What s Next? ü Commission estimated regulations would be adopted in 2014 and gradually implemented between 2015 and 2019 ü Device development programs nearing completion in 2013 should be able to proceed unhindered ü Sponsors in the early to middle stages of development would be wise to incorporate the proposed legislation into their planning process While implementation and oversight processes of the draft medical device regulations may vary, fundamental aspects are unlikely to change significantly Small to mid-sized sponsors, particularly those without an established presence in Europe, may benefit from partnering with company that has a seasoned regulatory strategy group and a team on-the-ground

Ques2ons?