Navigating the European Commission Website

Navigating the European Commission Website

Technology has made the ease (and magnitude) of information dissemination unthinkable to those accustomed to—and perhaps more comfortable with—the relay of information in the past, whether it was 50, 10, or even five years ago. Blogs, alerts, tweets, instant messages, texts, instantaneous news feeds, emails and many other methods all have contributed to this phenomenon. The general consensus likely would be that it is a lot of electronic communication delivery—a lot of alerts, rings, buzzes and vibrations. Thus, with the potential for today’s technology and the breadth of the Internet to give way to a bombardment of communication, many fall victim to “information overload.”

Minimizing the Overloadthe EU Device-Related Way

Relevant to the feelings of despair noted above—and in view of the move early this year of medical devices from the purview of the Directorate: General Enterprise and Industry to the Directorate: General Health and Consumers (DG Sanco)—in order to ensure and increase emphasis on patient and user safety,the European Commission website for medical devices has become increasingly “user-friendly” for competent authorities and manufacturers alike. Many crucial topics, guidance, and contact points can be accessed easily. To this end, this column will clarify the information publically available to manufacturers. In doing so, it is our hope to mitigate preconceived notions and perceived barriers to accessing data, and will bring about perhaps some much-needed tranquility in this society of information overload.

The Home Page

The first likely point of contact that competent authorities and manufacturers will access on the European Commission’s website is the welcome page for medical devices. Direct links to a multitude of important pages are provided, including those on regulatory framework, specific areas of development, market surveillance and vigilance, scientific and technical assessment, and dialogue between interested parties. Furthermore, the bottom of the page profiles current information: news, events and recently published materials.

Another useful tool of navigation is the left sidebar of the home page. Here, quick links to reference documents, other useful links, and questions and terms are easily accessible. The contents of these specific pages and their use to manufacturers are discussed in what follows.

Appropriately Named,Useful Links

As an aptly named and selected starting point from the welcome page, the European Commission has a page directed to “Useful Links,” which may be the second contact point a manufacturer would select. The page is divided into links (the European Commission, National Competent Authorities and others) that would benefit manufacturers with products already cleared for sale on the European market, as well as those attempting to commercialize devices.

Delving further, direct access to the 2010 medical device agenda of events, public health, scientific committees, working groups and task forces, and others are available. Similarly, general, vigilance and clinical investigation-related contact points are offered among the various national competent authorities, which, of course, is helpful for manufacturers with member state-specific questions.

Another section of particular interest to manufactures is the section on notified bodies, which is included under the heading “Other Contact Points.” In addition to the link to the New Approach Notified and Designated Organisations Information System website, the link to the European Association of Notified Bodies for Medical Devices is provided, as is access to the Notified Body Operations Group.

Finally, other contact points that may be of use to manufactures include: the European Committees for Standardization, Electrotechnical Standardization, the European Telecommunications Standards Institute and the numerous European Trade Federations. They all are organized in a single location on the site. On this note and of further assistance to manufacturers with product-specific inquiries, links are available to trade federations for radiological, electrical, diagnostic and dental equipment, as well as contact lenses, hearing instruments and others. Again, this section may provide substantial clarification for specific queries.

Reference Documentsand Revision Dates

Another useful page under the breadth of the European Commission website is a page that organizes the reference documents relevant to device manufacturers. Full text documents of current legislation are available for download, the most useful of which for medical device manufacturers is the EU’s Medical Device Directives, though the In-Vitro Diagnostic Device Directive and Active Implantable Medical Device Directive also are available. Implementing legislation, which includes Eudamed (the European Databank on Medical Devices) and technical specifications on in-vitro diagnostics are delineated. Classification documents, the MEDDEVs (Medical Device Directive guidelines), consensus statements, standards and others also are centrally located on this page.

The strengths of this page come from its explicit organization, reference of revision dates, and the linking of documents as well as their public accessibility.

Market Surveillance & Vigilance

Starting from the home page, a site dedicated to market surveillance, vigilance and Eudamed, easily is accessible to manufacturers. The text reminds manufacturers that the enforcement of regulations is within the purview of each individual member state. To this end, National Competent Authority Reports (NCARs), aim to document certain adverse events, typically those that result in field safety corrective actions. Furthermore, NCARs are disseminated to other competent authorities, with a copy provided to the EU Commission. The ultimate goal of all these programs is to ensure patient and user safety throughout the European Union. These NCARs are linked from the Market Surveillance and Vigilance page, under the link to vigilance reports.

Details published within the NCARs include the country (member state) in which the incident occurred, dates of reception, the competent authority report reference number, and the local reference number. (Based on this information, it is feasible in some cases, to obtain details about these reports from an individual competent authority’s website.) There are reports that summarize the number of NCARs exchanged each year, as well as the competent authorities that made them available. Additionally, there are statistical analyses of the most recent completed year. Thus, the statistical analysis of NCARs reported in 2009 is, at present, the most current.

The NCAR information demonstrates that the competent authorities communicate with each other about vigilance and highlight the importance of vigilance and postmarket surveillance systems in the EU. Note that Eudamed was the subject of this column in this year’s June issue of Medical Product Outsourcing, and it is envisioned that it will be compulsory to exchange NCARs through Eudamed beginning May 1, 2011.

Answers to CommonlyAsked Questions

A third section, which only recently has come to our attention, is the “Questions and Answers” page of the EU Commission website. Common questions include:

• Does a European database for Medical Devices exist?

• Is my product a medical device?

• What is a borderline product?

• Where can I find guidance and examples on borderline products, medical devices, and/or medicinal products?

• Where can I find information about harmonized standards under the Medical devices directives?

• Which process does a medical device have to follow to be placed on the market?

As a quick note regarding the first question, the explanation of Eudamed is provided as well as the disclaimer that access to the Eudamed database is limited to Competent Authorities only. The link to the MEDDEV guidance tables is provided here as well. In concert, links to the CEN/CENELEC (the European Committee for Electrotechnical Standardization), as well as to a list of published harmonized standards also are available.

What Does This Mean?An Acronym Index

Finally, the fourth helpful section for device manufacturers attempting to navigate the European Union regulatory landscape is the European Commission-provided acronym index. Here, an alphabetical list of commonly used acronyms can be searched. Again, this index will be of great help, especially to newcomers of the European Union medical device regulatory scheme, who may be “lost in(abbreviated) translation.”

Tranquility at Last

We tackled this topic for our final column of 2010 because we certainly appreciate and feel the effects of “information overload” in our everyday lives.The Internet can be a treasure trove of medical device information, and the European Commission’s website hosts a wealth of knowledge and information. In expounding upon this topic, it is our hope that manufacturers will feel empowered and equipped to navigate the European regulatory process and all of its various intricacies.

Evangeline Loh, Ph.D., R.A.C., is vice president of regulatory affairs for Emergo Group, an international consulting firm providing regulatory, quality assurance and distribution consulting services. Emergo has offices in the United States, Europe, Japan, China, Canada, Mexico and Australia. Evangeline can be reached at [email protected]. Sage Farrar is a regulatory research associate at the Emergo Group.