Devicemakers should expect to see the European Council’s final version of the proposed medical device and in vitro medical device regulations next month, an EU industry official says.
John Brennan, director of regulations and industrial policy at MedTech Europe, says there’s a 90 percent chance the Council will wrap up its three years of confidential talks and sign off on the proposal next month. If that happens, the proposal would go to the health minister on June 19.
Once the health minister has the two documents, the European Parliament, Council and the European Commission will work to finalize the regulations. Each body has created its own draft and the Council’s is the last to be released. Brennan, who provided the update at MedCon 2015 in Cincinnati, Ohio, expects the regulations to be enacted in the first half of 2016.
The negotiations have been tricky because each of the EU’s 28 member states must agree to implement the regulations to the letter of the law, Brennan says. Previously, countries could tweak EU recommendations on device regulation to fit local conditions.
Key changes include increased traceability requirements, better central control over notified bodies and a stricter approach to hazardous materials used in devices. The proposed regulations would impose an immediate four-year ban on any manufacturer found to use hazardous substances, but Brennan says that will be stepped down to a sensible and science-based approach the industry would support.
Changes to IVD regulations, including requests for clinical evidence that rise to near-pharma level, may cause the most challenge, Brennan says. “The whole IVD discussion is being overshadowed by the device discussion.”
Another concern, he says, is that the current versions of the regulations don’t properly differentiate requirements that would be imposed on Class III devices from requirements for all devices. That could lead to problems if the stricter standards are imposed sector-wide, Brennan says.
Industry would also like to see more forward motion on unique device identifiers throughout Europe, Brennan says. The concept of using UDIs to build a centralized database is widely supported, but has been stymied by inaction at all levels, he says. — Elizabeth Orr