EU Rules on Medical Devices Reached Sooner than We Thought

On May 25, 2016, the various European Union (EU) negotiators have finally reached a deal (four years in the making) on new rules for medical devices and in vitro diagnostic medical devices (see EU press release here). This was unexpected and, although formally there are a couple of further procedural steps, companies active in this space should now assume that the rules are final and will be in force in 2016 (but subject to delayed implementation). In addition to the twenty-eight EU countries, five other countries will be covered by the rules (including Norway, Switzerland, and Turkey).