Evangeline Loh & Stewart Eisenhart Since the European Union’s New Legislative Framework

Evangeline Loh & Stewart Eisenhart

Since the European Union’s New Legislative Framework, or its updated “New Approach,” went into effect in early 2010, its impact on the directives regulating medical devices and in-vitro diagnostic devices (IVDs) has yet to be fully explored by most authorities. Intended to modify marketing of all products regulated by New Approach directives across the European Union, most Competent Authorities have shown little inclination to consider the impact of the New Approach on medical device directives until the recast of the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) addresses it. The original New Approach first was published in the early 1990s. The modernization of the New Approach for marketing products was adopted in the European Union in July 2008. As readers may recall from the September 2008 edition of this column, the “new” New Approach requires that all products subject to these directives comply with all relevant aspects and possess CE Marking.

One of the components of the updated regulation has been how the framework defines “economic operators,” which includes manufacturers, authorized representatives, importers and distributors. By including importers and distributors as economic operators, the new legislative framework seeks to boost market surveillance and recall capabilities throughout the EU.

Existing medical device directives feature extensive and familiar definitions of manufacturer and authorized representative functions, but nothing on the responsibilities of distributors or importers in the medical device regulatory process. As such, including those entities more fully within the scope of medical device regulation presents a major new addition to the EU’s regulatory framework. Incidentally, the General Product Safety Directive (2001/95/EC) defines other professionals in the supply chain as wellas distributors.

Most Competent Authorities, however, have not yet codified those new importer and distributor requirements into their own playbooks when they transposed Directive 2007/47/EC into their regulations—the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)’s transposition certainly did not include importers and distributors.