Members Only: Global Hamonization

Members Only: Global Hamonization

Evangeline Loh, Stewart Eisenhart

If you grew up in the 1980s, chances are you owned—or maybe your parents owned—a familiar fashion item called the Members Only jacket (and those of us with these jackets still in our closets certainly are dating ourselves). In 2004, after bankruptcy, the company that made the iconic coat was bought and began to recreate itself, once again developing a devoted following.

What do 30-year-old coats have to do with medical devices? Not a whole lot. But the theme of reinvention certainly does.The Global Harmonization Task Force (GHTF), which is the topic of this article, is re-launching itself. The group recently announced plans to close up shop and reform as a regulators-only body in order to further advance harmonization of medical device regulations worldwide.

This column previously has covered the GHTF as it is a seminal organization. How the GHTF’s move will impact medical device regulatory efforts going forward—particularly in the European Union, which has closely followed the organization in terms of publishing guidelines—remains to be seen. In apparently demoting the role of industry associations in future harmonization efforts, however, the GHTF’s founding members’ action seems in step with recent tactics by European regulators to lessen the involvement of industry trade groups in their decision-making processes. Many European Commission medical device expert group meetings now host sessions limited to regulators only.

Industry Caught By Surprise

Until now, one of the key characteristics of the GHTF that may explain European markets’ willingness to adopt and comply with the organization’s recommendations was the inclusion of industry groups as full members. Now that the GHTF plans to proceed as a regulators-only entity, how readily European markets align with regulatory requirements becomes an open question, though European regulators still will seek insight from GHTF’s successor entity.

According to a GHTF spokesperson, the meeting held in February to discuss “future directions … had been foreshadowed and was not unexpected.” Emphasizing the perceived need for streamlined regulatory processes to reduce time to market for manufacturers, the group’s founding members saw a regulator-led harmonization task force as the best method to pursue those needs.

“Input and advice from industry will continue to be vital, and the new forum will also allow for input from other stakeholders such as healthcare professional groups, academia and consumers, as appropriate,” read a GHTF statement describing its future goal as shifting from developing its global regulatory model to developing harmonized guidance at an operational level.

Based on their initial reaction to the GHTF’s news, however, industry trade groups were neither expecting nor pleased with the organization’s announcement. Eucomed, the European medical device industry trade group, issued a joint statement along with the major U.S., Japanese, Canadian and Australian trade associations describing the GHTF’s move to reform and restrict membership as unilateral and “without advance consultation.”

“The associations regret that the regulatory authorities diminish the value of the contributions to be made by the industry under the new arrangements and emphasize the need for ongoing commitment by the regulatory authorities to the GHTF model and maintenance of the integrity of the documents developed by GHTF which underpin that model,” stated Eucomed’s official response, clearly demonstrating their displeasure.

E.U.: Close Ties

Since the GHTF’s founding in 1992, E.U. medical device regulators have been highly engaged and involved in the group’s initiatives, and fashioned many of their own requirements on those developed by the GHTF. Examples of the GHTF’s strong influence on European medical device regulations include: premarket regulatory submissions, quality systems and vigilance. Such influence hardly should come as a surprise when one considers that the chairs of some of the E.U. Study Groups also serve as European regulatory representatives.

GHTF Impact: E.U. Premarket

The GHTF’s Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED), developed as a way to harmonize documentation showing evidence of conformity for submission to regulatory authorities or conformity assessment bodies, has been endorsed in whole by the European Union (through statements provided by the E.U. Commission). The similarity of the European Medical Devices Directive MDD 93/42/EEC Annex I, Essential Requirements, to the GHTF Essential Principles, certainly facilitates this, as well as the GHTF principles of conformity assessment and the MDD 93/42/EEC.

While the European device directives do not provide guidance on the format of a Technical File/ Design Dossier submission, many Notified Bodies have their own guidance and there is an old Notified Bodies Medical Devices guidance on Technical File compilations. The GHTF Summary Technical Documentation guidance provides a succinct format, template, and presentation for a Technical File, and this has become the approach many medical device manufacturers have adopted.

The GHTF’s Study Group 5 (SG5) pushed for convergence of regulations pertaining to evidence of clinical safety and performance, which in turn became incorporated into the European Union’s approach to generating and presenting such evidence. The MEDDEV 2.7.1 (Rev. 2) guidelines on Clinical Evaluation Reports were modified significantly in December 2009 to Rev. 3. The chairperson of this GHTF Study Group was Susanne Ludgate, U.K. Competent Authority at the Medicines and Healthcare products Regulatory Agency, who also championed the E.U. MEDDEV 2.7.1 revision. The revised guidelines on clinical evaluations are based largely on the Clinical Evaluation guidance issued by the GHTF’s SG5. In particular, there is significant discussion about the guidance’s methodological literature review. This MEDDEV now often is cited by Notified Bodies when they issue nonconformities to manufacturers for their lack of clinical data, a clinical evaluation report, or a clinical evaluation report that does not resemble the guidance.

GHTF Impact: E.U.Quality Systems

The GHTF’s influence on E.U. regulators also is apparent pertaining to quality system regulations. Rather than issue its own guidance on quality systems, the European Union opted to reference the GHTF’s quality system guidance instead.

GHTF Impact: E.U. Vigilance

The European guidance MEDDEV 2.12.1 (Rev. 4) was significantly modified in April 2007 to reflect the GHTF guidance on the topic. In particular, terms such as Field Safety Corrective Action and Field Safety Notice were borrowed outright from the GHTF. Many other definitions also were adopted from the GHTF vigilance guidance. Once again, the chair of the GHTF Study Group 2 was an official from the E.U. Commission, Isabelle Demade. The European Union has a National Competent Authority Report (NCAR) system covering the exchange of data about serious adverse incidents within the E.U., and the GHTF’s global exchange of adverse event information is termed NCAR Exchange Program.

Until 2010, the E.U. Commission professed its commitment to working with the GHTF. In their 2010 objectives, E.U. regulators listed the work they’d done with the GHTF—particularly on post-market surveillance and vigilance—as a major consideration for international cooperation. Of course, as one of the GHTF’s five founding members, the European Union’s openness to implementing the organization’s guidelines over the past several years hardly seems unusual. As the GHTF reorganizes into a new entity, though, how slightly or significantly the new iteration’s mission and methods are will no doubt affect how readily European regulators adopt further recommendations.

Back Again

Unlike some fleeting fashion trends, some things have more of a long-term impact. There is no doubt that the GHTF in its new form will contribute to the success of harmonized global regulations. The GHTF certainly has many recognized accomplishments, and has had a beneficial impact on the European Union. In addition, the organization has made noted global accomplishments. It is believed that despite disappointment on the part of industry at no longer being directly involved, the importance of the organization will not be diminished in the future.

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].