Update on regulations and harmonisation
Progress is continuing towards a harmonised approach to certain aspects of devices and
biomaterials, similar to the ICH for pharmaceuticals and biologicals. The European
Commission and representatives of Canada, Australia and USA, are working on global
harmonisation of the approval process for devices containing human tissues, the first
stage of which is to establish common terminology and risk-categories.
CEN 12442, the standard for manufacture of medical devices containing animal tissues
and derivatives, has been approved and will be published during 1999. For comments on
European Standards see the contributions by Dr Julian Braybrook, Scientific Co-ordinator
of the European Biomaterials Network, to the Biomatera Newsletter. Also see Newsletter
Issue 3 - EU Standards and EU
Regulations.
In the USA, manufacturers of medical devices, represented by HIMA (Health industry
Manufacturers’ Association) and the FDA’s Center for Biologics Evaluation and
Research CBER are in negotation about ways to improve CBER’s performance in the
assessment of devices abnd diagnostics with biologic components. HIMA would like closer
co-operation between CBER and HIMA representatives in drafting responsible procedures and
guidance, as has occurred with the FDA’s Center for Devices and Radiological Health
(CDRH) CDHR handles the approval process for devices that are not involved in high-risk
blood processes such as transfusion, bone marrow implants, automated blood collection, HIV
diagnosis.
The Global Harmonisation Task force is currently working to complete a Global Medical
Device Nomenclature for the end of 1999, to replace the Universal Medical Device
Nomenclature System. the global nomenclature will be used to encode all information about
devices in the European Union into the European Medical Device Database EUDAMED. EUDAMED
is being developed and finalised by the German medical data institute DIMDI and is
currently going through a period of data validation and problem-solving. Once EUDAMED is
fully-functional, it will carry information from manufacturers, Notified Bodies and Device
agencies on devices, and will be extended to include in vitro diagnostics during the
period up to the enactment of the IVD Directive in June 2000.
Although France appears to be taking a less rigorous line on implementation of its
extremely strict draft laws on medical device regulation, it has banned mercury
thermometers from 1st March 1999, because of the potential hazards from the
glass structure and the mercury contents when the thermometers are used for measuring
internal temperatures.
  
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