Originally published as Covington E-Alert on September 26, 2012

Today the European Commission published its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices (IVD) will be replaced by two Regulations: one Regulation on medical devices and one Regulation on IVDs. Importantly, unlike Directives that must be implemented into national laws, the Regulations will be directly applicable in all EU Member States.

The proposals are published against a very emotional background in the EU due to the recent breast implants and metal-on-metal hip joint replacements scandals. They will now be reviewed by the European Parliament (EP) and the Council, the institution grouping the Member States. Adoption is foreseen in the course of 2014 and the new rules may gradually take effect six months to three years later.

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