Positive outcome in EU Parliament for workers in Medical Devices Industry in Offaly

Today (22nd October) the European Parliament “Voted to ensure higher levels of safety for patients  using Medical Devices while helping to ensure the long term sustainability of the Medical Devices Industry in Ireland”, this was stated by Independent MEP Marian Harkin after the plenary vote in Strasbourg.

She said: “This industry employs in excess of 25,000 people and has an annual turnover of almost €8bn with 2 medical devices firms located in Offaly.

“It is of the highest importance that we prioritise patient safety ensuring that those who have implanted medical devices such as pacemakers or hip joints can rely on a quality assurance certificate. Up to now, each Member State had at least one Notified Body to assess Medical Devices, however there was a real difference in standards applied in different Member States.  This in effect, meant that unsafe and unreliable medical devices could find their way onto the European market.

“However the proposal from the European Parliament 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 ensures a sufficient safety net for patients.

“Crucially for the industry in Ireland, there will be legal certainty for medical device companies and the authorisation process will be streamlined. This will help ensure a competitive advantage for manufacturers that apply the highest standards and will, in the long run, help to ensure the retention of jobs in the sector.

It is now up to the Council of European Environment Ministers to finalise negotiations with the Parliament on this piece of legislation.  It is important that we have legal certainty for patients and for medical devices companies.  I would urge Minister Phil Hogan to try to ensure a speedy outcome and ensure finalised legislation at the earliest possible date,” Marian Harkin concluded.