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Legal clarity for Galway’s medical devices firms following EU vote
Galway bay fm newsroom – Galway’s 38 medical device companies have received some legal certainty following a vote in the European Parliament.
North West MEP Marian Harkin says a proposal now ensures that for high risk medical devices, such as pacemakers, hip replacements or teeth implants, only special Notified Bodies would be designated by the European Medicines Agency to assess the devices.
Also the Assessment Committee for Medical Devices shall provide an opinion as to the validity of the clinical data in particular cases.
This, she adds, ensures a sufficient safety net for patients.
The Council of European Environment Ministers will now finalise negotiations with the Parliament on the legislation.