The European Parliament has advanced proposed medical device regulations that would, in part, establish a body of experts to handle regulation of high-risk devices and create an implant registry.
Next, the battle moves to member states, which are represented by the European Council. That body will make its own decision on the issue, after which Parliament and Council members will hash out a final law. In other words, the med tech industry and consumer advocates still have time, in theory, to shape the final law.
European legislators said the proposed legislation as it now stands seeks to strike a balance between making medical device manufacturing information more transparent and traceable, and not adding undue burdens to small device companies.
Typically, independent organizations known as "notified bodies" approve most devices under a relatively quick timeframe. In September, the European Parliament's environment committee backed moving instead toward a stringent, centralized, premarket approval process similar to what is used in the U.S. for high-risk devices such as hip replacements and artificial heart valves.
Members of Parliament voted to require notified bodies to have a "team of in-house experts who meet up-to-date qualification requirements." In addition, they supported the creation of "a new group of bodies" to assess high-risk devices and implants. That's greater scrutiny, to be sure. But as the Irish Times reported, an amendment secured ahead of Parliament's vote removed a premarket approval requirement except if there are worries over specific products.
The proposed law, as it now stands, would boost public access to clinical data, so both patients and doctors could pick the best, safest products. The EU would also require every implant patient to be registered and receive an implant card, so they can be easily tracked and notified if safety problems arise.
As well, device-approval changes would establish clearer responsibilities for reprocessing single-use devices, and boost safety rules for the use of in-vitro diagnostic medical devices.
A push to toughen European device regulations began in the wake of an admission by the now-defunct French company Poly Implant Prothèse that it had made substandard breast implants for years. Lobbying groups including AdvaMed in the U.S. and Eucomed have not opposed reforms per se, but resisted a movement to a full U.S.-style PMA system, arguing it would harm smaller medical device companies and add too many delays to the European approval process.
- read the European Parliament announcement
- here's the Irish Times story