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In our News entitled "GMP for Medical Devices - Lessons learnt from the PIP Scandal?" published at the beginning of February, we dealt with the scandal of falsified breast implants. The EU Commission had asked its "scientific committee on emerging and newly-identified health risks (SCENIHR)" for a rapid scientific opinion about the risks for the safety of these breast implants. This document entitled "The Safety of PIP Silicone Breast Implants" has now been published. The Commission has also commissioned another study.
On 9 February, John Dalli, Commissioner for Health and Consumer Policy, delivered a speech to the press and called the EU Member States to take immediate action at national levels to enforce the full and strict application of regulations regarding medical devices (please see the EU Commission press release). Mr Dalli named following immediate actions:
- Reviewing the designation of all notified bodies
- Ensuring that those bodies are able to carry out conformity assessments (including unannounced inspections)
- Reinforcing market surveillance (particularly spot checks)
- Improving the functioning of the vigilance system (i.e. systematic access to adverse events)
- Supporting the development of tools ensuring the traceability of medical devices.
Finally, Mr Dalli announced a stress-test (which should consider the deficiencies in the PIP case) to take into account in the revision of the regulations for medical devices. These revisions should be adopted in the course of the next six months - please see the respective Roadmap (dating from last year, though).
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2008_sanco_081_proposal_medical_devices_en.pdf(34.06k)
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scenihr_o_034.pdf(469.91k)
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scenihr_q_030.pdf(26.68k)
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