On Tuesday, 22 October, during last week’s plenary session in Strasbourg, the European Parliament voted in favor of legislation that will strengthen regulatory controls on medical devices, increase the ability to trace the product back to its supplier, and increase the availability of information to patients.  Prior to this legislation, the European Union has been operating under a regulatory framework for medical devises that was established by three directives in the 1990s; however, the stipulations were complex, and there was a lack of EU-wide uniformity on patient protection.  Without a streamlined approach to the regulation of medical devices, obstacles to the function of the single market arise, minimizing the benefits that could result from a truly integrated industry within Europe.  Moreover, the advances made in the medical field in the past twenty years have created new challenges that must be dealt with head on, but the dated pieces of legislation have proven inadequate in adapting to this progress. 

The call for a new directive began after a number of scandals, such as the PIP scandal and the hip “metal on metal” scandal, in the health field rattled the public and called into question the validity of the current system.  In 2011, it was discovered that one of the global leaders in silicone implant production, the French-based company Poly Implant Prothese, had replaced medical-grade silicone with industrial-grade silicone in their implants in order to save approximately 1 billion euros each year.  The casing around the implants also proved to be flawed, for they were prone to split, leaking the chemicals into thousands of women’s bodies. It was later also revealed that the same company also used this silicone replacement in male chest and testicle implants. Besides potential for rupturing the silicone contained industrial elements never tested for possible effects on the human body. Though the number of men having had these potentially problematic products inserted in not known, it is estimated that around 400,000 women around the world had implants with untested silicone.

Although the Commission had previously been working on a new proposal for medical devices, the PIP scandal hastened the work on a more vigorous directive to protect the public from the possibility of a repeated incident. 

Not only do faulty medical devices cause pain and increase the health risks for patients, but they also cost health systems enormous amounts of money.  Therefore, Parliament’s Environment, Public Health, and Food Safety committee proposed the creation of expert groups by the European Medicines Agency to assess “high-risk” devices.  In addition, greater transparency regarding the origin of a device will be required, so that in the case of a recall, swift and effective action can occur.  Patients will now receive an “implant card” prior to a procedure to ensure their understanding of all aspects of the medical device they are about to receive.

Although this legislation makes great advances in the regulation of the medical field, many fear that it did not go far enough.  The specialist body created by the EMA, known as the Assessment Committee for Medical Devices, will be able to make recommendations regarding new technologies, but they will not have the force of law within member states.  Moreover, the continuous clinical assessments of medical devices will occur once they hit the market, as enforcing pre-market surveillance was not agreed upon by the Parliament.  As a result, Monique Goyens, director general of the European Consumer organization, complains that consumers of medical devices are being treated as “guinea pigs”. 

After the 22 October vote, the European Parliament must accelerate negotiations with member states over the directive in order to legalize it before the 2014 Parliament elections. 

David Casa is a Nationalist MEP