The European Union (EU) represents one of the largest medical device markets in the world.1
In the 1990s, regulation of these medical devices across the European Economic Area (EEA), which includes the EU’s 27 member states as well as Norway, Iceland, and Liechtenstein,2
was harmonized under three medical device directives.3
At present, this regulatory regime faces criticism over the complexity of its legal framework, deficiencies in its ability to address emerging technologies, and the lack of uniformity across member states. In late 2010, the EU commission released a roadmap for a proposed “recast” of the medical device directives.4
This article provides a brief overview of current EEA medical device regulation and describes potential features of the upcoming recast, highlighting opportunities for device manufacturers to both prepare for and shape these regulatory reforms as they emerge.
Medical Device Directives Current State of Play
The current medical device regulatory regime is comprised of three directives: the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMDD), and the In Vitro Diagnostic Medical Device Directive (IVDD). The MDD applies to any device used for “the diagnosis, prevention, monitoring, treatment or alleviation of disease” that does not act by pharmacological means.5
The AIMDD covers any device that is intended to be placed inside the body, remain after the procedure, and rely on a power source “other than that generated by the human body or gravity.”6
Finally, the IVDD applies to any device intended “to be used in vitro for the examination of specimens… derived from the human body.”7
The EEA member states are required to implement the objectives of these directives in their own national laws.
No supranational EU regulatory body enjoys comprehensive regulatory authority over medical devices; instead, each member state enforces its own national law promulgated pursuant to the three directives through a National Competent Authority (NCA). Member states also designate independent organizations known as notified bodies (NBs) to certify device manufacturers’ compliance with the regulatory requirements. The particulars of these “conformity assessments” vary depending on the classification of the device and the directive that is applicable.8
Medical devices are classified into four groups (Class I, Class IIa, Class IIb, and Class III) based on risk, considering such factors as invasiveness and duration of contact with the body.9
IVDs similarly fall into four groups, with a general IVD default class, two “Annex II” classes (“List B” for medium-risk devices and “List A” for high-risk devices), and a self-testing IVD class for devices intended for use directly by lay individuals.10
Generally, the conformity assessments of higher-risk devices include greater NB involvement and more rigorous requirements. Lowest-risk devices require only a self-declaration of conformity by the manufacturer with no NB involvement, while higher risk devices may require “type examinations” (in which an NB scrutinizes a representative sample of the device), and the highest risk devices may require a full quality assessment involving audits and unannounced visits by the NB. All devices must be supported by clinical data (though manufacturers of lower-risk devices may satisfy this requirement by compiling currently-available literature on devices shown to be “equivalent” to the subject device). In addition, manufacturers must register their device and implement a post-market vigilance system to collect and report information regarding adverse events. Once the conformity assessment is complete, the manufacturer has the right to affix a Conformité Européenne
(CE) marking to the device, indicating that the device conforms with the essential requirements of the directives. CE marked devices may be sold anywhere in the EEA.11
In recent years, this regulatory framework has undergone a number of developments. A modifying directive passed in 2007 and implemented in 2010 expanded the post-market surveillance requirements for medical devices, heightened the standards for certain clinical data requirements, and added software to the list of items that constitute medical devices.12
In addition, as of May 1, 2011, NCAs are required to submit information on device certifications, clinical investigations, and vigilance-related data to the European Databank on Medical Devices (EUDAMED). The databank is only accessible to NCAs and the European Commission and is intended to streamline the process of bringing medical devices to market by eliminating the previous requirement of separate notification to each member state in which certain devices were sold.13
Concerns with Current Medical Device Regulation in Europe
Despite these changes, the medical devices regulatory framework continues to face a variety of criticisms. Perhaps most prominent is the concern that, by delegating regulatory authority to NCAs and NBs, the directives provide for little coordination between EEA States, resulting in a lack of coherence between States’ policies, little uniformity in the execution of NB conformity assessments, and allegations of subsequent forum shopping by device manufacturers. In addition, the scheme has been called “fragmented and difficult to follow,” given that it is formed by three primary directives and multiple modifying directives.14
Other concerns include a shortage of NB expertise with which to assess emerging technologies, difficulties in the application of the directives to new technologies (such as devices that consist of human tissues, implantable devices intended only for aesthetic purposes, and genetic tests that do not serve medical objectives), and the need to better align the framework with the Global Harmonization Task Force (GHTF) model increasingly being followed by the EEA’s primary medical devices trading partners.15
Noting these concerns, the European Commission has declared its intent to institute a “recast” of the medical device directives. In 2008, the Commission conducted a public consultation seeking input from industry members, regulatory authorities, healthcare professionals, and other stakeholders regarding the regulatory system and possible targets for reform.16
A second consultation in 2010 solicited opinions regarding changes to IVD regulation, and a conference co-chaired in March 2011 by the EU Health and Consumer Commissioner discussed the topic of “adapting the EU’s medical device legislation to the needs of tomorrow.”17
The Commission’s Work Programme 2011 now includes the recast of the three directives as an initiative for the 2012 legislative agenda, and a proposed roadmap for the recast was released in November 2010.18,19
Changes to Come
To date, the specific contours of the proposed recast remain fluid. Rather than articulating a concrete plan for reform, the Commission’s roadmap offers a list of potential options. These include replacing the MDD and AIMDD with one comprehensive directive, issuing an updated directive to replace the current IVDD, and/or encouraging greater harmonization across EEA States by, for example, streamlining conformity assessment procedures and clarifying key concepts and terms. More radical proposals include substituting regulations (which are directly binding and applicable on all EU member states without the need for implementation) for the more flexible directives-based approach (which allows member states to implement the objectives in their own national laws in a variety of different ways) and establishing a centralized EU medical devices regulatory authority comparable to the European Medicines Agency (EMA), which regulates certain pharmaceuticals on a supra-national level.20
Industry interest groups such as Eucomed do not appear to favor a fundamental revision of the current framework...
While the details of the recast continue to take shape, stakeholders have begun reacting to the Commission’s intended reforms. In February 2011, five of the most prominent NBs issued a voluntary Code of Conduct for Notified Bodies, articulating minimum qualifications for NB personnel, establishing rules for the execution of conformity assessments, and offering guidelines by which NBs may better harmonize their assessments. Participation in the Code is currently voluntary and available to any recognized NB. Enforcement measures are currently being designed and are expected to be published by January 1, 2012.21
Industry interest groups such as Eucomed do not appear to favor a fundamental revision of the current framework, although they recognize that the current regime could be improved. In particular, Eucomed opposes the establishment of a premarket authorization procedure by regulatory authorities, which they believe would result in longer deadlines and higher fees and would be detrimental to competition and innovation. Eucomed has also opposed the centralization of the current framework by providing the EMA authority over medical devices out of concern that the EMA’s involvement would add unnecessary red tape to the process.22
Medical professionals have also promoted the implementation of reforms. In January 2011, the European Society of Cardiology held a Policy Conference on the Clinical Evaluation of Cardiovascular Devices and called for the creation of a single regulatory system for medical devices. The Society advocates either the creation of a new agency or the delegation of authority to a division of the EMA.23
Despite the European Society of Cardiology’s stance, an article published in the British Medical Journal in May 2011 concludes than an FDA-style regulatory framework for Europe is unlikely to materialize.24
The results of the 2008 and 2010 public consultations offer additional indications as to the reforms that are likely candidates for inclusion in the recast. Both consultations reveal wide support among stakeholders for greater consistency with the GHTF model including an increased emphasis on risk in IVD classification. Responses to the 2010 consultation showed broad support for an IVD batch release verification requirement and continuation of the regulatory exemption for IVDs used only as in-house tests, as well as moderate support for increased regulation of direct-to-consumer genetic tests and clarification of the requirements regarding IVD performance demonstration.25,26
The data also suggest some support for replacing the directives with regulations, but reveal a concern that such an undertaking would involve a large expenditure of administrative resources.
Particularly significant in this regard are the views of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which regulates one of the biggest medical device markets in Western Europe.27
MHRA opposes greater EMA involvement in device regulation, and, instead, has proposed the creation of a “general management style committee drawn from member states” to ensure consistency in the interpretation and implementation of the regulatory scheme.28
MHRA also supports the adoption of a risk-based IVD classification system and “strongly advocates retention of the in-house exemption.”29
The agency has been hesitant to offer support for many other reforms absent further elucidation of specific details.
Expected Timeline and Upcoming Events
Given the potentially significant impact of the changes on the horizon, medical device companies should take note of anticipated timelines to ensure their ability to participate in the process. According to the Commission’s roadmap, adoption of a medical device directives recast is expected for the first quarter of 2012.30
However, the Commission has yet to specify a deadline for the publication of a final reform proposal, which must subsequently be approved by both the European Parliament and the Council of the European Union. According to recent statistics released by the European Commission, the average duration of the legislative approval process between 2004 and 2009 ranged from approximately 15 months to 44 months.31
Given the potentially significant impact of the changes on the horizon, medical device companies should take note of anticipated timelines to ensure their ability to participate in the process.
In the meantime, the Commission is preparing an impact assessment to analyze the costs and benefits of the various reform proposals, and “[NCAs], [NBs], industry, medical professionals, patients and other interested stakeholders will… be requested to submit information and data on the impact of the envisaged measures through targeted consultation.”32 Although a targeted consultation solicits opinions only from a defined target group, the “minimum standards for consultation” state that when selecting relevant parties the Commission should consider “the need for specific experience, expertise or technical knowledge” and should include even the views of organizations from non-member states, ultimately ensuring “that relevant parties have an opportunity to express their opinions.”33 According to the roadmap, the Commission’s Medical Device Experts Group conducts “continuous consultation” with stakeholders. In light of the potentially significant impact of these reforms, device manufacturers and other stakeholders should look for opportunities to participate in the reform process as specific details continue to emerge.
John R. Manthei is a partner in the Washington, D.C. office of Latham & Watkins and serves as Global Co-chair and Washington, D.C. department chair of the Healthcare and Life Sciences Practice.
Carolyne Hathaway is a partner in the Washington, D.C. office of Latham & Watkins. Her practice focuses on matters involving the FDA. In addition to her legal training and practice, Ms. Hathaway has a technical background in chemistry and the biological sciences, and an MBA in health care management.
Elizabeth Richards is an associate in the Washington, D.C. office of Latham & Watkins where she focuses her practice on regulatory and transactional matters for health care, medical device, pharmaceutical, cosmetic and other biotechnology industry clients. She has advised on regulatory and compliance issues involved in various stages of the biotechnology product life cycle in the US, Europe and Mexico.
5. Council Directive 93/42, art. 1, 1993 O.J. (L 169) 2(a) (EC).
6. Council Directive 90/385, art. 1, 1990 O.J. (L 189) 2(b) (EC).
7. Council Directive 98/79, art. 1, 1998 O.J. (L 331) 2(b) (EU).
9. See generally Directorate Gen. for Health & Consumer Prot., European Comm’n, Guidelines Relating to the Application of the Council Directive 93/42/EEC on Medical Devices, MEDDEV 2.4/1 Rev.9 (2010).
10. Med. and Healthcare prods. Regulatory Agency, Guidance Notes on In Vitro Diagnostic Medical Devices Directive 98/79/EC 11 (2006).
11. Underwriters Labs., supra note 8, at 1.
15. See Roadmap, supra note 4.
18. Annexes to the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Commission Work Programme 2011, at 23, COM (2010) 623 final (Nov. 27, 2010).
19. Roadmap, supra note 4.
21. See BSI et al., Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC (2011).
23. Alan G. Fraser et al., Clinical Evaluation of Cardiovascular Devices: Principles, Problems, and Proposals for European Regulatory Reform, Eur. Heart J., May 14, 2011, at 11.
25. See Recast, supra note 16.
30. This timeline is reiterated in the Annex of the Commission’s Work Programme 2011, which includes the Recast as a legislative priority for 2012.
32. See Recast, supra note 4, at 6.
33. Communication From the Commission: Towards a Reinforced Culture of Consultation and Dialogue - General Principles and Minimum Standards for Consultation of Interested Parties by the Commission, at 19-20, COM (2002) 704 final (Dec. 11, 2002).