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September 24, 2013
2 Min Read
The European CE Mark system for medical devices moves closer to a new regulatory upgrade. Over the upcoming weeks, members of the European Parliament will vote on regulations for medical devices. However, a recently-introduced set of amendments are being rushed through this process, according to Serge Bernasconi, CEO of Eucomed.On the 25th of September, European regulators in the Environment Committee will commence a vote on the new regulations. In part, the new regulations come on the heels of the PIP breast implant scandal in France. In that scandal, PIP, a breast implant manufacturer, used substandard silicon in the production of implants. Many of these implants led to health issues for their recipients. In thousands of cases, breast implants had to be removed.While most of the proposed changes have been accepted without discord, regulations surround the new approval system have been met with some controversy.The Commission proposed a set of regulations that included a scrutiny procedure. Before this past summer, there had been numerous views on the issue in Parliament. However, regulators are still battling over one part of the regulations: Amendment 22.Amendment 22 has received some negative feedback from Eucomed, an industry group. According to this industry group, Amendment 22 is rushed. The amendment includes a proposal for 600 new experts and a series of committees. This system, designed to add an additional level of scrutiny during the medical device review process, was created to improve medical device safety and efficacy.However, industry groups worry that Amendment 22 is rushed. In particular, Eucomed worries that the added bureaucracy could introduce delays and increase government costs.On top of this, Eucomed argues that Amendment 22 wouldn't bring a noticeable difference to patient safety. Since Eucomed doesn't see how the amendment would impact patient safety, it doesn't see the need for this legislation.That being said, Eucomed does come out in favor of several different measures that would improve medical device manufacturing safety. These include post-market controls, manufacturer checks, hospital checks, labeling and product tracing systems, better qualification of notified bodies and unannounced visits.As of now, patients in Europe receive access to medical devices earlier than most other developed countries. While the United States has a bureaucratic approval system (described as similar to Amendment 22), the current European approach is alleged by Eucomed to be faster than the United States. For example, the news service argues that there are seven million hypertension patients in the United States who are stilling waiting to receive access to the same renal denervation technologies as available in Europe.While Europe has been an entry-point for medical device devices over the years, the latest regulatory changes in the country could put a sour taste in the mouths of many medtech manufacturers.
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