The recast of devices--not your typical fishing expedition.Duplicity isn't intended by the headline. The reader should be cautioned that it was not referring to the type of recasting one usually associates with the summer--throwing one's fishing rod back in the water. Indeed, one typically expects news to slow in July and August. Particularly in Europe, August is notoriously (or perhaps happily for Europeans) known to be languid. It is the month when many Europeans go on holiday, and the exodus that occurs in Europe is epic and should not be underestimated. That said, interesting developments have occurred that require reporting before one totes his or her beach blanket to the shore.
Recast of the Medical Devices Directives
To the surprise of many, on May 6 the European Commission initiated an inquiry about the Medical Devices Directive to invite public comment on the next revision of directives MDD 93/42/EEC, IVDD 98/79/EC and AIMDD 90/385/EEC (as well as modifying and implementing directives, such as Directive 2007/47/EC). The "Recast of the Medical Devices Directives, Public Consultation" is a questionnaire that was used to query the public for opinions on directives related to medical devices in Europe, with an emphasis on the impact to small and medium-sized enterprises (SME), as well as areas pertaining to cost and savings to these SMEs.
The European Commission has said the directives need to be simplified while simultaneously strengthening the "whole legal framework to give as high a level of protection of public health as possible." As such, the commission identified many weaknesses in areas related to notified bodies, vigilance, market surveillance and transparency. Nine legal instruments are being considered.
As of press time, the deadline to provide responses to this recast was July 2. Al though by the time you read this column, the deadline will have passed, this doesn't mitigate the importance of the recast or obviate readers from being aware of this document--and the future ramifications that may ensue. While the commission expects to publish a proposal by the end of 2009, the recast initiative will consider these changes for the next five through as many as 15 years.
A short discussion of the more pivotal items follows--and surely makes for entertaining beach reading (or perhaps a way to pass the time while casting your line during a fishing expedition). This is not an exhaustive discussion but a highlight of the main elements described. The European Commission's Web site (http://ec.europa.eu) provides a copy of the recast.
The scope of medical device regulations in Europe has been questioned. For example:
* Should there be one directive (ie, one text) that encompasses all medical devices--medical devices, in-vitro diagnostic devices and active implantable devices? The explanation for the three separate directives is historical as opposed to a technical or legal justification.
* Is it better to classify in-vitro diagnostic devices based on a risk-based classification scheme, in contrast to the existing list system--Annex II List A, Annex II List B, self-test and other (self-certification)? At this time, the Global Harmonization Task Force (GHTF) Study Group I is proposing such a strategy and provides a draft document on the topic at its Web site (www.ghtf.org).
* Should the current scope of medical devices be expanded to include medical devices composed exclusively of nonviable human cells and/or tissues and/or their derivates as well as medical devices incorporating non-viable human cells or tissues and/or their derivatives with an action ancillary to the medical devices?
* Would quasi medical devices, such as implantable and invasive products (typically implanted or injected) without a medical purpose, be more safely regulated as quasi medical devices and within the purview of medical device legislation?
More questions arose in this area as well:
* Do the existing Essential Requirements in Annex I of the Medical Devices Directive need to be adapted or reinforced?
* Do additional new Essential Requirements need to be generated, especially if other device categories were included within medical devices? The recast questions whether "harmonised [sic] specific requirements" should be created that specify mandatory methods of manufacture testing or material composition for specific devices. This would permit the voluntary standard system to exist simultaneously with mandatory requirements.
With 27 member states and potentially 27 systems member states use to notify the European Commission of Notified Bodies, the transparency into the competence and performance of the approximately 80 notified bodies was questioned:
* Is there an appropriate mechanism to harmonize and ensure the consistent designation and monitoring of notified bodies? How does the community ensure the safety of the highest risk category of medical devices? Should the review and approval of high-risk medical devices involve a centralized agency, the European Medicines Agency (EMEA)?
* Is it wise to form a committee on medical devices within the EMEA? The European Commission views this as a consolidation of expertise.
* Should the EMEA also monitor non-high-risk devices and have access to the evaluation reports of all notified bodies?
As one can observe, many questions are being raised to which the European Com mission has sought answers from the public. The latter proposals were some of the more extensive recommendations or questions in the recast questionnaire, as well as the Commission's attempt to address the its observation of the non-uniform level of safety in the clinical evaluations to date.
The Commission observed a "low overall reported rate of incidents" and noted that these discrepancies seem implausible. How is it possible that devices are safer in the European Union than around the world and that devices are safer in certain member states than in other member states? The Commission concluded that there has been a significant under-reporting of incidents in the European Union.
With this conclusion, multiple proposals have been suggested to facilitate a uniform reaction in the member states to vigilance issues: mandatory user reporting, mandatory notified body review of a manufacturer's vigilance system, requirement for the EMEA to coordinate vigilance reports, authorization for the European Commission to impose restrictive measures, and a mandatory provision for international information exchange.
The European Commission lamented that market surveillance needs to be improved and confusion exists regarding how to operate the market surveillance system as specified by the directives. The Commission recommended one of the following as ways to improve the member state control of the market: a central European registration system, a revision of market surveillance regulations, the strengthening of provisions for the Commission to coordinate where required and an opportunity to solicit involvement of the EMEA for scientific opinions.
The legal framework for medical devices is challenging to comprehend in the European Union for a number of reasons. There are three main directives and six implementing directives. National variation also occurs as member states are required to transpose the directives into their national legislation or regulation. Furthermore, there are a variety of routes to conformity assessment (modules presented in the annexes of the directives) that are confusing.
This section of the questionnaire entertained a few solutions to those challenges, and it sought to identify particular elements that flummox even the most experienced and expert regulatory professionals. Of most significance, the document questioned whether a formal regulation (which immediately and directly would be applicable to member states) would be most beneficial.
The recast also discusses a few other sections, such as Specific Update following the revision of the New Approach; Borderline Cases; the GHTF; and Imports, Exports and Counterfeiting.
The recast is a fascinating document, especially since eight months earlier Directive 2007/47/EC was published, and months were invested to negotiate the provisions of the revision. That said, with this recast the European Commission has presented many propositions and ideas to address inadequacies of the system. The European Commission truly was fishing for opinions, so it will be worthy to note the outcome. Obviously, everything in life requires improvement; however, some of the modifications seem like a wholesale revision.
Evangeline Loh, PhD, RAC is director of regulatory affairs for Emergo Group, an international consulting firm providing regulatory, quality assurance and distribution consulting services. Emergo has offices in the United States, Europe, Japan, China, Canada and Australia. Evangeline can be reached at firstname.lastname@example.org.