Nov 23, 2010

Under-reporting of incidents and general weaknesses in vigilance are no strangers to Europe's vast medical device regulatory landscape. In fact, this concept was addressed in this article. At the time, we wrote, "... the [European] Commission observed a ‘low overall reported rate of incidents ...' [and] concluded that there has been a significant under-reporting of incidents in the European Union." In that column, we also noted the various proposals that had been suggested in response to the European Commission's findings, including mandatory user reporting, mandatory notified body review of a manufacturer's vigilance system, a requirement for the European Medicines Agency to coordinate vigilance reports, authorization for the European Commission to impose restrictive measures, and a mandatory provision for international information exchange.

Interestingly, Emergo Group representatives recently met with the Dutch Healthcare Inspectorate. The agency emphasized that given the number of medical devices on the market in the Netherlands, it too experiences under-reporting. From a cultural perspective, it is fascinating to follow these trends of under-reporting compared to other world markets where, by comparison, industry seems to be hyper-vigilant.

So how far has vigilance progressed in Europe? Have incident reports increased since the initial observations of under-reporting were noted?

Progress Being Made

Awareness of the importance of vigilance and notification largely has increased during the past two years. To this end, European competent authorities now are much more cognizant that reporting is low. They are working to improve this area and increase communication and reporting of vigilance. Some of these efforts are described below.

The European guidance on vigilance, MEDDEV 2.12.1, was revised in December 2009. Repurposed here, Revision 6 imposed slight technical changes to its predecessor (2.12.1 Revision 5), including minor modifications in verbiage of the input fields in the Incident Report Form. Also, the incident report form is now available on the European Commission website as a PDF, with fields that can be completed and submitted electronically. As a general reminder, remember to reference Revision 6 of the MEDDEV if citing this guidance in any of your company documents and procedures.

Efforts at the National Level

In an attempt to increase vigilance and patient safety, competent authorities have become more mindful of monitoring self-declared devices, which are those that are not subject to notified body review inspections, including random checks and on-site inspections at manufacturers' facilities and/ or their authorized representatives.

On the topic of incident reporting at the national level, more information increasingly has become publically available. In fact, in one measure to increase incident reporting and promote vigilance, many competent authorities now dedicate a section of their website toward vigilance and make available a list of reported incidents. The detail to which these websites report incidents varies across member states, however, and some smaller member states still do not provide this data. As an example, Swissmedic, Switzerland's regulatory agency for therapeutic products; the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA); and Germany's Federal Institute for Drugs and Medical Devices all have Web pages where specific details on the manufacturer, product, product details, references and dates of recalls or Field Safety Corrective Actions (FSCA) are posted. These three competent authorities' websites also include the Field Safety Notice (FSN) initially provided by the manufacturer. Using a somewhat modified approach, France's regulatory agency posts medical device alerts, and, as previously noted, many of the smaller EU member states do not provide any information on incidents.

Incidentally, it should be noted that Germany's agency has a new PDF form for vigilance that fulfills the new German requirements for reporting, which became mandatory on March 21, 2010. When German authorities transposed Directive 2007/47/ EC, they included a new requirement on vigilance that mirrors MEDDEV 2.12.1 Revision 6. Along these lines, the MHRA website also includes a comprehensive and straightforward electronic reporting system to facilitate incident reporting for healthcare professionals, users and manufacturers. Electronic reporting systems are recommended in MEDDEV 2.12.1 Revision 6, where Section 5.1.6 (details to be included in manufacturer reports) specifically delineates: "In the interests of efficiency, reporting by electronic means (email, online database system, xml, etc.) is encouraged."

The European Commission's Efforts

At the highest level of the European Commission, measures also have been taken to encourage vigilance. As one example, a PDF document exists on the European Commission website that notes incidents reported by member state competent authorities. It appears as though the notices that are relayed to the European Commission are only FSNs related to FSCA, and that a greater number of reports are posted on individual competent authorities sites than on this European Commission record.

In addition to the posting of incidents that already have occurred on the European Commission website, moving forward, the creation of the central database, EUDAMED, should help to unify vigilance measures throughout the European Union. EUDAMED is slated to be operational by May 2011. One element required for EUDAMED's success is a translation of the global medical device nomenclature codes into the more than 20 different EU languages. In fact, EUDAMED will serve as a database that will collect details on incidents and, according to the European Commission, will "give an overview to every member state of the incident history of a device present on the market." Related to this goal, EUDAMED will include any information on incidents or near incidents of a particular medical device.

Also noteworthy, in its Work Programme 2010, the European Commission indicated that one of its objectives is "the promotion of an effective cooperation between the competent national authorities for the implementation of the vigilance system (in particular through the Medical Device Expert Group for Vigilance)."

And lastly, the EU Commission initiated an exploratory process on the future of medical devices and invited both private and public health interests involved in the medtech sector. In their final report, members of the exploratory process indicated the following:"Some members of the exploratory process noted that the current EU regulatory system provides European patients with timely access to good and up-to-date medical technology. However, the group recognized that there is room for improvement in order to continue to ensure patient safety and the functioning of the internal market are achieved, whilst not strangling industry's ability to thrive. This is particularly true for post-market surveillance and vigilance activities, especially as new distribution channels allow for easy access to counterfeit and non-compliant products."

An additional effort to highlight vigilance and to facilitate communication among regulatory authorities is the Global Harmonization Task Force's proposed National Competent Authority Report Exchange Program, which was designed to improve discussion and awareness of issues related to vigilance among NCAR participants worldwide.

Similar to the increasing trend among European regulatory authorities, manufacturers also need to be vigilant about vigilance. In fact, the vigilance guidance emphasizes that in situations where doubt exists, "there should be a predisposition to report." Regulatory authorities routinely are communicating about vigilance and monitoring the global vigilance reports and, as always, any pertinent updates that will affect the medical device industry will be addressed in this column.

Originally published in May 2010


  • support