EU Revision in Focus: From Directive to Regulation

EU Revision in Focus: From Directive to Regulation

Evangeline Loh and Stewart Eisenhart

The European Union’s long-anticipated revision of its Medical Device Directives has prompted considerable speculation among industry participants and observers—naturally, given the lack of final details thus far. But EU commissioners recently have provided more substantial clues as to what the revision will entail and how it will work—and itlikely will not be a recast.

Most recently, Jacqueline Minor, director of Consumer Affairs at the European Commission’s Health and Consumer Policy division, presented a “recast” update at the annual Regulatory Affairs Professional Society (RAPS) conference held inIndianapolis, Ind., on Oct. 24. The material corroborated information recently presented in other venues.

Emphasizing that the revision is intended to bolster the EU’s existing regulatory system, Minor said that amending that system would enable better support of innovation, more rapid access to market for device manufacturers as well as balance between pre- and post-market controls and cost effectiveness. Although the revision identifies and targets weaknesses in the current system, Minor pointed out that 80 percent of European manufacturers are small to medium-sized enterprises (SMEs); any revisions to the EU regulatory system, therefore, must ensure minimum negative impact on the industry.

EU Council on Innovation

Anyone who has been monitoring the activities in the European Union will remember that the EU Council published its conclusions on medical device innovation (2011/C 202/03) over the summer. The EU Council noted in its document, which reflected a synopsis of the High Level Conference on Innovation (March 22), the importance of innovation in the medical device sector balanced by strengthening the weaknesses in the regulatory system. According to information presented at that meeting, there are 18,000 SMEs in the European Union. It certainly would appear that the EU Commission is in harmony with the EU Council.

Directives vs. Regulations

Most interestingly, Minor revealed that the EU Commission was considering regulations—one for medical devices and active implantable devices, and another for in vitro diagnostic devices (IVDs)—rather than directives as part of its revision effort. The significance of this distinction is that a regulation would go into effect across all EU member states as written, with no transposition by national authorities. Directives, on the other hand, require transposition on the national level, making EU harmonization of medical device market requirements harder to achieve. Some critics now contend that the EU harmonization of the medical devices sector has been plagued by differences in national transpositions of the Medical Devices Directives. As an example, to deal with the divergent national interpretations of the Cosmetics Directives’ national transpositions, the cosmetic products legislation was promulgated as a Cosmetics Regulation.

A potential difficulty in adopting regulations rather than directives, however, is that every aspect of a regulation would be subject to inspection and scrutiny by the European Parliament and EU Council. Had the directives been recast, only the topics that were subjected to revision would be discussed.

According to Minor, the EU Commission has completed its impact assessment of proposed Medical Devices Directiverevisions—a prerequisite of any newinitiative in the European Union. Minor and other EU Commission sources have indicated that publication of draft regulations (as well as release of the Impact Assessment) will happen in April or May of next year.

Scope of Revisions

Until draft regulations are published, the complete scope of the EU revisions remains unknown. And, one can only prognosticate. Sources have suggested, though, that the following previously unregulated products will fall under the new regulation’s requirements: products incorporating non-viable human tissues or cells; aesthetic products; in-house laboratory tests; genetic tests for the purpose of diagnosis; and diagnostic services involving assessments performed outside EU borders.

Minor also reiterated during her RAPS presentation the areas of the EU medical device regulatory process that have been targeted for improvement.

These include:

• Improved and more consistent oversight of Notified Bodies;

• More consistent requirements for clinical investigations;

• Boosting post-marketing safety efforts;

• Improving regulatory and market transparency within the process;

• Centralized agency for review ofcertain medical devices;

• Making public some information in the Eudamed medical device database; and

• Making greater use of Unique Device Identifiers (UDI).

Specific Elements

In terms of improving the Notified Body system, EU regulators have suggested increased oversight of Notified Bodies via mandating minimum requirements and also more consistent designation and monitoring practices, as well as perhaps implementing EU-level assessors to ensure more uniform standards of conformity assessment are applied by Notified Bodies. The Notified Bodies also are furiously circulating their Notified Body code of conduct document.

Regarding multi-site clinical investigations, EU regulators are proposing designating lead Competent Authorities to handle initial technical assessments, in addition to enhanced engagement of Competent Authority post-marketing safety monitoring, as well as more consistent safety reviews and vigilance assessments. To enhance transparency of the medical device regulatory process, regulators also may provide more public access to some of the medical device information available in the European databank, Eudamed.

Of course, expanding medical device regulations to cover new products and improve processes such as controversial product classification also requires enhanced management and administrative tools. As such, Minor reported that the EU Commission is considering either a group within the European Medicines Agency or the Joint Research Centre as a candidate to serve as a central agency overseeing the new regulations. The idea of introducing a panel of clinical scientific experts and a network of national reference labs was presented.

Other issues that revised EU regulations should address, according to Minor and EC Commissioner John Dalli, who presented at the Eucomed Medtech Forum Oct. 12 in Brussels, Belgium, include reprocessing of single-use devices; regulatory discrepancies between tissue-related products covered by pharmaceutical regulations and EU tissues and cells regulations; and evaluation of nano-materials used in some medical devices.

Furthermore, Dalli said, guidelines developed and published by the Global Harmonization Task Force (GHTF) will inform efforts to revise EU medical device directives. As such, recent GHTF guidance documents on issues such as UDI, IVD classification, and harmonized conformity assessment principles.

The Crystal Ball

While not mentioned recently, it is fully expected that the EU IVD regulation will implement a classification system similar to that suggested by the GHTF and promulgated by the Australian IVD regulations. The majority of respondents to the IVD directive public questionnaire were in favor of a risk-based rules classification system. Of course, it also is unspoken that one outcome of the revision will be the demise of some Notified Bodies. The EU Commission has notunequivocally stated that the revision will involve medical device regulations—it certainly appears that this will be the result.

Lastly, the ultimate prognostication—the estimated date the regulations become enforceable—would seem at the earliest to be 2015.

As we conclude the year, we wish our readers a joyous and happy holiday season. We fully expect the events of 2012 to keep this column entertaining.

Reference:

1. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:202:0007:0009:EN:PDF

Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group, aninternational medical device consulting firm providing regulatory, quality assurance and distribution consulting services. Evangeline can be reached at [email protected].