Events

No current events.

Italian - ItalyEnglish (United Kingdom)

Breast implants from Company P.I.P. - Recommendations from the Ministry of Health for the management of patients with such implants

On April, 1st 2010 the Italian Ministry of Health issued a memorandum, after having being notified by the French Competent Authority for medical devices (AFSSAPS), concerning the recall from the market of the silicone gel-filled breast implants manufactured by P.I.P. (Poly Implant Prothese). This was due to an increase in the number of reported incidents involving these medical devices. The most likely reason for this was that the implants were actually filled with a gel that is different from the one that was stated in the technical dossier of the device.

French Authorities are now investigating on these events. Meanwhile, the italian Ministry of Health has recently issued another memorandum, with several recommendations for the management of women that have already been implanted with these prostheses. Both documents are available on the Ministry website - Medical Devices area (link - italian only).

 
Commission report on the reprocessing of medical devices
Thursday, 02 September 2010
A report from the Commission to the European Parliament and the Council on the issue of the reprocessing of medical... Read more...
Decreto Ministeriale 11 giugno 2010 - Informazioni da fornire per il monitoraggio dei consumi di dispositivi medici acquistati dal SSN
Wednesday, 11 August 2010
There are no translations available.Il D.M. 11 giugno 2010 istituisce la banca dati per il monitoraggio dei consumi dei... Read more...
Italian Ministry of Health sets up an experimental procedure for Companies that wish to submit applications for health advertising authorisations
Monday, 02 August 2010
Italian Ministry of Health announced that a new procedure will be tested, starting from October 1st 2010 and until... Read more...
Breast implants from Company P.I.P. - Recommendations from the Ministry of Health for the management of patients with such implants
Thursday, 01 July 2010
On April, 1st 2010 the Italian Ministry of Health issued a memorandum, after having being notified by the French... Read more...
New MEDDEV 2.4-1 rev.9 published on the EC website
Monday, 28 June 2010
Rev. 9 of the guidance document MEDDEV 2.4-1 on the classification of medical devices was published on the EC website... Read more...
  • Di Renzo Regulatory Affairs
  • Viale Manzoni 59
  • 00185 Roma
  • Tel: +39 0677209020
  • Fax: +39 0670450099
  • direnzo@direnzo.it
  • http://www.pharmaflash.com
  • MSN: newsletter@direnzo.it
  • Skype: di.renzo.regulatory.affairs
  • Di Renzo Regulatory Affairs P.I. 07227271009