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Paving the way for harmonization
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Today the worldwide harmonization of clinical evaluation and reporting is one of the main issues for manufacturers of medical devices. To be in the forefront of the harmonization discussions gives the opportunity to play a strategic role and to be informed in an early stadium. We are proud our product manager Gert Bos has been nominated to join the Study Group 5 of the Global Harmonization Task Force on Clinical Evaluation.
This task force is founded by the main regulatory regions USA, Canada, European Union, Japan and Australia. In the person of Gert Bos, KEMA represents the joint Notified Bodies in Europe. The start of this study group shows the growing importance of clinical evaluation and post market surveillance.‘Clinical evidence has always been an important aspect in evaluating high risk medical devices’, explains Gert Bos, who has comprehensive experience as supervisor of clinical evaluation reviewers. ‘Given the proposed changes to the Medical Device Directives, the focus on clinical evidence will be enlarged in the near future for lower risk products as well. When at the long-term global harmonization is achieved, the time to market of medical devices will be decreased significantly: one set of clinical data might cover the worldwide market regulatory requirements.
Dr. Bos hopes to bring his experience in evaluating the variety of clinical evidence in the process of CE marking to the discussion table. ‘Being a frontrunner enables us to let our customers be compliant in time.’ We’re looking forward to sharing his findings with you.
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