Compliance Timelines Medical device firms have some time, however, to establish full compliance w

Compliance Timelines

Medical device firms have some time, however, to establish full compliance with the directive. EU member states must complete transposition of the directive into national legislation by Jan. 2, 2013; medical devices commercialized before July 22, 2014, and IVDs commercialized before July 22, 2016, must comply with the RoHS Directive by July 22, 2019. Makers of active implantable medical devices get a reprieve because their products are exempted altogether from the new requirements.

On the other hand, new devices brought to market after July 22, 2014, as well as new IVDs commercialized after July 22, 2016, will need to comply with the RoHS directive as soon as they enter the EU market.