As the United States expands the scope of the FDA Unique Device Identification (UDI) system to include additional medical devices classes, other countries are moving forward to create similar UDI systems to better identify medical devices from the manufacturer, through the supply chain, to the patient.
The International Medical Device Regulators Forum (IMDRF), the European Commission and the U.S. Food and Drug Administration (FDA) are working together with other regulatory agencies across the world toward the ultimate goal of increasing patient safety and optimizing healthcare through the implementation of a globally harmonized, consistent approach to medical device identification.
Device manufacturers that distribute in the U.S. are likely already familiar with the process that led to the formulation of FDA’s final rule on UDI. It may be helpful, though, to understand how the process is likely to differ in the European Union (EU), which is actively formulating its own UDI regulations.
More National Autonomy – While medical devices in the U.S. are overseen by the FDA as a centralized regulatory body, the regulatory landscape in the European Union is more complicated. The EU is an economic and political affiliation of sovereign nations covering most of Europe. Each of those countries retains the ability to formulate policy independently of one another and the group as a whole. This means that each nation has its own regulatory body to oversee products that are sold within that country’s borders. As a consequence of this structure, the EU’s UDI system may involve a longer path toward consensus to reach its final stages.
Impacts from Political Change – Policy for the European Union is created by three institutions: the European Parliament, the Council of the European Union, and the European Commission (EC). Comprised of representatives from each member country, the EC proposes new policy, which is debated and voted on by Parliament and the Council. The EU UDI initiative has been under development for a lengthy period, a process which had to be rejuvenated after the 2014 election of new members.
Different Policy Path – The FDA and EC have different paths toward policy finalization. In the United States, the FDA publishes a Proposed Rule, receives public comment for a period of time, then publishes a Final Rule that often incorporates suggested changes. As deemed necessary, the FDA also releases draft and final non-binding Guidance documents to clarify the specifications. The FDA generally defines the results it expects from industry, but leaves much of the specific process on how to meet those requirements up to individual companies. In the case of UDI, for example, the FDA requires medical device manufacturers to submit device data to the Global Unique Identification Database (GUDID) but there are multiple methods by which manufacturers can accomplish those submissions and three different standards a company can choose from for their Device Identifier.
The EC typically works to build consensus during the drafting phase after which it proposes legislation to the European Parliament and the Council of the European Union for approval. Legislation can be in various forms: a regulation (act or law) that has binding conformance by the European member states, a directive allowing member states to pass their own laws to meet the stated goal, a decision with focused application to a person or group, or a recommendation which is simply a non-bonding declaration. On April 5 2013, the EC issued a recommendation for a UDI system and provided a high level description. It is expected that a binding regulation will be approved in the 2016 timeframe to launch the UDI system throughout Europe. It will most likely be followed by more detailed Guidance Documents from the EC that define an implementation schedule based on device class and type (device, implantable device, or diagnostic device). The Guidance is also expected to specify the device data reporting details and expansion of the current medical device database, EUDAMED, for information storage.
As industry and regulators from the United States, the European Union, Asia Pacific and other regions work together to shape a global set of UDI guidelines, Methodize will closely follow the development of new policies and regulations so we can keep you updated. Our UDI data solution is built with not only the current FDA GUDID requirements in mind, but also with our clients’ future global UDID data needs in mind. Please feel free to contact us with questions about how your company can take steps to prepare now for upcoming UDI mandates in Europe and around the world.
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Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell) www.methodizeinc.com