The latest December 10, 2013 discussions between EU Member States on new EU medical device and in vitro diagnostic (IVD) regulations reveal continued disagreement on key elements of the proposed regulations. As a result, the adoption of the proposed regulations prior to European Parliament elections in May 2014 is becoming increasingly unlikely.
As described in previous updates (available here and here), the proposed regulations were published by the European Commission in September 2012, and are intended to replace the current three EU directives regulating medical devices, IVDs and active implantable medical devices. The European Parliament adopted its position on the proposed regulations, including significant amendments, in October 2013 after extensive deliberations.
Two of the most discussed and controversial elements of the proposed regulations relate to the authorization and oversight of devices, and the reprocessing of single use devices.
More specifically, there is no agreement yet between EU Member States on whether there is a need for increased pre-market scrutiny, in particular regarding high-risk devices, or whether strengthening post-market oversight is sufficient. Similarly, EU Member States have expressed various different positions regarding the reprocessing of single use devices, ranging from imposing on reprocessors requirements equal to those applicable to manufacturers, to leaving it to each EU Member State to address reprocessing nationally.
In order to move towards the adoption of the proposed regulations, EU Member States must reach agreement on these and other elements of the regulations, before entering into negotiations with the European Parliament and Commission to agree on a final text. The UK, France and other Member States have encouraged Greece, which takes over the Presidency of the Council of the EU for six months as of January 2014, to focus on finalizing the process.
Although Greece has indeed indicated that it intends to prioritize the finalization of the proposed regulations, it is becoming increasingly unlikely that agreement will be reached in time to ensure adoption before the European Parliament elections, potentially leading to a need to re-assess elements of the proposed regulations and consequently further delays.
Considering that the proposed regulations will govern the medical device and IVD industry in the EU for considerable time once adopted, stakeholders should continue to monitor the legislative process, and make efforts to ensure that the final text of the proposed regulations is sufficiently balanced.