In September 2012, the European Commission released a proposal for new European Medical Device Regulations (EMDR) intended to prevent public health scandal, such as the Poly Implant Prothèse breast implant in France. The final version of the EMDR is expected to be approved in late 2014 or early 2015. However, a more likely estimate is October 2015. The original proposal indicated that there would be a three-year transition period (from 2014 to 2017/2015 to 2018) for implementation of the new regulations.
The new regulation may increase costs and eliminate early access to device innovations that patients in Europe are used to experience. A survey made by the trade group Eucomed estimated the cost of the proposed regulations at €17.5 billion (US$24.3 million). European Union's current financial situation could force the European Council and Parliament to make major revisions to the proposed regulations reducing the cost of implementation.
The original proposal has suffered several modifications, but most significant changes include:
- The European Commission’s ability to create common technical specifications (CTS) will be expanded to all devices.
- Formatting of declarations of conformity and technical files will be revised.
- Manufacturers will be subject to unannounced audits by Notified Bodies.
- Spinal implants, devices that control and monitor active implants, nanomaterial, apheresis machines, and combination products will be reclassified as Class III devices requiring technical documentation known as a design dossier.
- Most in vitro diagnostics (IVDs) will require Notified Body involvement.
- A Unique Device Identification (UDI) system will be required for labeling, and the European Databank on Medical Devices (Eudamed) will be expanded.