With the decision by the Global Harmonization Task Force to proceed as a regulators-only organization, the willingness of European markets to align with regulatory
requirements becomes an open question.
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 noncon-formities 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.
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 guid-
ance. Once again, the chair of the GHTF
Study Group 2 was an official from the E.U.
Commission, Isabelle Demade. The Euro-
pean Union has a National Competent Au-
thority Report (NCAR) system covering the
exchange of data about serious adverse in-
cidents within the E.U., and the GHTF’s
global exchange of adverse event informa-
tion is termed NCAR Exchange Program.
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, an
international medical device consulting firm
providing regulatory, quality assurance and
distribution consulting services. Evangeline can
be reached at firstname.lastname@example.org.