The First to Go Formal

The First to Go Formal

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.

Poland Forges a Path

A recent transposition by the Polish Competent Authority, the Office for Registration of Medical Products, Medical Devices and Biocidal Products, of the MDD incorporating the new New Approach, however, may offer a path toward a more uniform application of the framework for medical devices, including a blueprint for how to expand the Directive’s scope to include all four economic operators.

The Polish Competent Authorities’ transposition of EU medical device directives—the Act of May 20, 2010, on Medical Devices, Official Journal Laws 2010, No. 107, Item 679—includes the MDD as well as the AIMDD and the In Vitro Device Directive (IVDD). The Polish transposition occurred only recently and went into effect in September 2010. Despite—or because of—that delay, the Polish law provides the first instance in the EU of formalized obligations imposed upon importers and distributors of medical devices. Whether or not other member states rely on Poland as a precedent to fashion their own requirements under the updated New Directive remains to be seen, but the fact that the authorities in Poland have set up a substantial and rigorous set of rules for importers and distributors should not go unnoticed by regulators, notified bodies or industry.

Significant Obligations

If Poland’s compliance requirements for medical device importers and distributors prompt similar requirements in other EU markets, those firms will face some heavy lifting in order to meet such requirements.

Chapter 3 of the law, Obligations of Importers and Distributors, enumerates various obligations importers and distributors will have to meet to participate in the Polish medical device market. Some firms likely already are performing some of these tasks as part of their business processes, but not all.

Importers, for example, must ensure prior to commercializing a device that the product’s manufacturer or authorized representative conducted an adequate conformity assessment; that the manufacturer already has designated an authorized representative for the device, that the device has achieved CE Marking, and that device information from the manufacturer meets essential requirements. It is the Polish importer or distributor who is required to notify the Polish Competent Authority of Class IIa, IIb, and III medical devices as well as IVDs.

Polish importers and distributors also are more accountable for product safety according to the Polish law. First, Polish importers and distributors (by definition with local presences in Poland) are required to cooperate with the office of the president as well as the manufacturers and authorized agents of their devices in the event of safety issues and recalls. Refusal on the part of Polish importers or distributors to cooperate in this regard will result in penalties.

Any information firms receive from patients and users regarding negative side effects of their devices must be passed on to the products’ manufacturers or authorized representatives as well as the Competent Authority chairperson. Firms also must keep documentation establishing the origin and identification of a device for five years following introduction of that product to the Polish market.

In addition, importers and distributors must now meet added responsibilities in terms of ensuring proper labeling andinstructions for use, as well as proper storage and transport of devices. These firms also must meet significant conformity assessment requirements for products they market in Poland, and maintain documentation of assessments for five- or 15-year periods depending on a particular device’s nature.

Reactions to thePolish Transposition

The Polish approach to economic operators ultimately serves as a model for the broader European approach. At a May 6 meeting in Warsaw of the Polish Competent Authority with European Association of Authorized Representatives members including Emergo Europe, reactions to the Polish law’s treatment of importers and distributors seemed appropriate in relation to the activities performed by importers and distributors.

The responsibilities the Polish law places upon importers and distributors have no precedent among other member states, where regulators to date typically have focused on manufacturers and authorized representatives.

In the United Kingdom, for example, there are no requirements for the United Kingdom-based distributor or importer to be licensed or registered with MHRA. The Irish Competent Authority, Irish Medicines Board (IMB), also does not place requirements on Irish importers or distributors. The IMB did recently survey individuals about the licensing of Irish distributors and importers, but no further steps have been taken yet. In Italy, France and Spain, notification requirements exist for Class IIa, IIb and III products, but importers and distributors are under no obligation to provide those notifications.

The Belgian Competent Authority has taken a slightly more hands-on approach in this area. For IVDs, the authority requires information on Belgian distributors of those products.

Not Over Yet

The updated New Approach certainly will be considered by more Competent Authorities in the recast of the MDD, AIMDD and IVDD. Hence, it only will be a matter of time before it is apparent whether the Polish Act serves as a blueprint for the European Union. Whether any added responsibilities imposed upon importers and distributors across multiple member states would impact the overall business climate for medical devices in the European Union warrants careful consideration ahead of the recast.

Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group, an international medical device consulting firm providing regulatory, quality assurance and distribution consulting services. Evangeline can be reached at [email protected].