The European database, EUDAMED, was meant to be fundamental to information exchange, but was never financed properly,
and until now is not functioning across Europe. This has led to the
promulgation of a variety of different and sometimes overly complex and burdensome national device registration schemes. Directive
2007/47/EC revising the AIMDD and MDD required the European
Commission to ensure that EUDAMED begin to function by 5
September 2012 at the latest, and report on the operation of the system by 5 October 2012. Notably, a European Commission decision
published on 19 April 2010 formally established EUDAMED and
requires member states to start using it from 1 May 2011, with all
current data entered by 30 April 2012 at the latest.
The Global Medical Device Nomenclature (GMDN) is a system
of internationally recognised coded descriptors in the format of
preferred terms, with definitions used to generically identify medical
devices and related healthcare products. Its purpose is to provide
authorities, healthcare providers, medical device manufacturers and
suppliers, conformity assessment bodies and others with a single
naming system to support the exchange of data between competent
authorities and others and the exchange of postmarket vigilance
information, and for inventory purposes. After a promising start,
progress stalled, and the programme is only now beginning to move
forward. The system is far from ideal, however, with new terms
being added and existing terms becoming outdated and unaccept-
able for some national registration schemes. In addition, manufac-
turers must purchase codes, so use of GMDN by manufacturers,
particularly those outside Europe, has been slow. Some believe that
access to codes must be free if GMDN is to achieve its objective of
becoming truly global.
Future directions
The European approach to medical device regulation is under constant evaluation and scrutiny. Instead of concentrating on improving
the existing system, some parties wish to drastically change the regulation of medical devices and adopt procedures similar to those used
for the approval of medicinal products. Medical devices are far too
diverse and different from medicinal products to benefit from such
a simplistic approach. The current European system of regulating
medical devices is not perfect, but it only needs improvement, not a
complete overhaul. The European Commission, in concert with competent authorities, industry, Notified Bodies, and other stakeholders,
is working on a “recast” of the directives, with an anticipated date of
implementation before the end of 2015. It is to be hoped that revision
rather than rewrite will be foremost on the Commission’s mind. 1
Maria E. Donawa
Donawa Lifescience Consulting, Piazza Albania 10, I-00153 Rome, Italy
tel. + 39 06 578 2665, e-mail: medonawa@donawa.com
www.donawa.com
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emdt.co.uk European Medical Device Technology
June 2010 | 15
