Revision of the medical device legislation

“In revising our regulatory system, we want to keep the positive aspects whilst remedying identified weaknesses and addressing future challenges.”
John Dalli, European Commissioner for Health and Consumer Policy.

Video not available

Please watch video from 4.35 minutes onwards for Dalli’s statement on the medical device legislation.

Considering, the recent faulty breast implants scandal in Europe, 40,000 women affected alone in the UK, a revision of the medical device legislation is highly needed to tigthen controls, restore trust and increase patient safety. John Dalli, EU Commissioner for Health and consumer affairs urges for a review of Europe’s regulatory agencies and revision of the legislation. Directives 93/42/EEC and 98/79/ EC are affected. The Commission stated that the newly implemented measures will have a positive impact on surveillance of the European medical devices and diagnostics market.

In response to Dallis statement, Eucomed, which represents 22,500 medical technology companies in Europe, agreed to support the Commission in revising the medical devices legislation. “After analyzing the Commission’s proposal, Eucomed believes the measures are balanced and appropriate and will have a positive effect on patient safety,” it said in a statement. They suggest a legal framework that provides a consistent, EU-wide regulatory approach through improved coordination, evaluation and certification of medical devices; consistent and comprehensive implementation across all EU Member States, as well as efficient vigilance and market surveillance systems.


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