The recast of devices—not your typical fishing expedition

Medical Product Outsourcing, July-August, 2008 by Evangeline Loh

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.

Scope

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?

Evaluation Procedures

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)?