Call for stringent EU medical device regulations

LONDON -- Faulty breast implants at risk of bursting, and defective metal-on-metal hip prostheses, both raising grave concerns about patient health and long-term toxicity, have plagued the reputation of the medical device industry over the past year, states a GlobalData healthcare analyst.

Today, 26th February 2013, will see the future of medical device regulations in the European Union decided, as device manufacturers and European lawmakers convene at a European Parliament committee meeting.

This meeting will be a big milestone for both sides to find a way to strengthen regulations for receiving CE Mark approval. The need to strengthen existing medical device regulations has been highlighted by major device recalls over the past year, including the recalls of breast implants developed by the French company Poly Implant Prosthese, fabricated from substandard silicone. 

Priya Madhavan, MS, GlobalData analyst covering Cardiovascular Devices, explains the current regulatory process: “Medical device manufacturers first seek approval of their products in the European Union before making their way into the United States, because the CE Mark approval process is less stringent than the US FDA process, and manufacturers can bring their products to market approximately three years sooner than in the US. Device manufacturers are able to gain profits from selling their products in the EU and countries that recognize CE mark approval much earlier than in the US.

“However, it comes at a cost of potentially endangering the patient’s life if the device malfunctions as a result of not being subjected to a rigorous regulatory approval process.”

Market access for medical devices is regulated through the European Union medical device directives, which have been transposed into national law in each of the EU member states. The legal framework comprises three directives, the medical device directive, the active implantable device directive, and the in-vitro diagnostic medical device directive. These directives are designed to ensure that medical devices are safe, reliable and effective in patients. Compliance with the requirements of these directives is conferred by placing the CE Mark on the product, and supplying the device with a Declaration of Conformity. Regulation and reimbursement of medical devices are controlled by private firms (Notified Bodies) in each member state.

In March 2010, amendments were made to the medical device and active implantable device directives stating that all medical devices sold in the EU needed to have a clinical evaluation report in the technical file. Although these amendments reinforce the safety and performance of innovative healthcare technologies and will increase transparency, the existing regulations still need to be enhanced.

In an attempt to strengthen and update the regulatory process to keep pAir Force 1 Foamposite