The European Parliament's committee for environment health and food safety has voted for stricter regulation controlling the process of approving medical devices. The directive includes tougher conformity assessment bodies, a new system of labelling medical devices and a new body called the 'Assessment Committee for Medical Devices' to examine potentially high risk devices.
The new rules are intended to strengthen public health increase transparency in the wake of recent events such as the PIP breast implants scandal. Dagmar Roth-Behrendt, a member Gemany's SPD who sits in the European Socialist group said:
We have achieved our main objective: patients will be better protected from defective products. We were able to enforce our goals and to be more ambitious than the Commission proposal. We really needed to put patient safety first and to bring transparency to an industry that is quite unregulated.
We now hope that the improvements we have achieved will not be diluted later in the legislative process.
However the legislation was strongly condemned by Eucomed which represents 4500 designers of medical technology. The group described the legislation as:
A devastating financial blow to Europe’s 25,000 small and medium-sized device makers. The ENVI committee compromises patients and jobs in a what looks like a rushed through deal that seeks to satisfy the time pressure that Parliament feels ahead of the European elections, but not the needs of Europe’s patients and doctors. For several political groups, the outcome also represents a drastic shift away from their pro-innovation, pro-competitiveness platforms on which they are campaigning for re-election in 2014. It is now up to the political groups in light of the plenary vote in October to turn the “rushed deal” into a “right deal” for patients and jobs.
The group estimates that the new regulatory burden could cost €17.5bn (£14.7bn). The negative impact of the new regulations will be felt particularly by small and medium-sized companies in the sector. One of the most damming critiques Eucomed made of the proposed law was that the type of authorisation system proposed could make patients wait an extra three to five years before receiving life saving medical treatment. The draft law will be put to a vote of the parliament during the 21 to 24 October session in Strasbourg.