Extracts from the press conference by John Dalli on Safer, more effective and innovative medical devices

Type: Summary of press conference   Reference: I-074646   Duration: 10:02:10  Lieu:
End production: 26/09/2012   First transmission: 26/09/2012
On 26 September 2012, John Dalli, Member of the EC in charge of Health and Consumer Policy, gave a press conference to present the new rules aiming to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. The medical device sector is highly innovative, particularly in Europe and has an estimated market value of around 95 billion euro.

Only the original language version is authentic and it prevails in the event of its differing from the translated versions.
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TIME DESCRIPTION DURATION
10:00:00 Title 00:00:05
10:00:05 Soundbite by John Dalli, Member of the EC in charge of Health and Consumer Policy (in ENGLISH): The Commission has today adopted proposals for a new legal framework for medical devices and in vitro diagnostics medical devices. The safety of patients and consumers is a fundamental concern to me. From the very beginning of my mandate, I took the view that the in deep revision of the medical device legislation should be regarded as a priority. In addition, I, like many others, was shocked by recent scandal of breast implants. It reinforced our determination for action to avoid similar problems in the future. 00:00:39
10:00:44 Cutaway of a photographer 00:00:06
10:00:50 Soundbite by John Dalli (in ENGLISH): The two proposals adopted today aim at significant strengthening the pre and post market control of medical devices and at ensuring that patients continue having rapid access to innovative treatment. The improvement proposed will make the legal framework more robust, transparent and better adapted to scientific and technological progress. At the same time, they will support innovation and competitiveness of the medical device sector. 00:00:31
10:01:22 Cutaway of the audience 00:00:05
10:01:27 Soundbite by John Dalli (in ENGLISH): I believe that these new rules will not only ensure the safety of consumers but they will also bring back full confidence of the consumers in the market which is also our objective. I do not know the reasons why these new rules should be unsafe for consumers. I can assume that it is again the issue of the reaction to the preauthorisation of medical devices. We still maintain that premarketing authorisation will lead to delay the market access. 00:00:42
10:02:10 Departure of John Dalli 00:00:13
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