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European Union approval times lend support for third-party review

This article was originally published in Clinica

Executive Summary

The first analysis of medical device approval times in Europe under the medical device Directives shows that most high-risk products are reaching the market within 120 days of quality system approval. Produced by Gordon Higson, director of MTCE (see page 16) and consultant to the European Commission on global harmonisation activities, the study provides ammunition for critics of the US regulatory system which takes up to three times longer to approve devices. The study has been cited in submissions to the Senate hearings on FDA reform to lend weight to the argument for third-party review to speed up the US process (see Clinica No 694, p 7 and this issue, page 9).

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