16 • ARTICLES WHO’S WHO LEGAL: LIFE SCIENCES Association for Medical Devices of Notified Bodies, has therefore requested that legislators grant the industry a fiveyear transition period before requirements relating to notified bodies under the new Regulations will apply. More cooperation between EU member states and the Commission At EU member state level, increased focus on surveillance has resulted in more cooperation and sharing of information. For example, the frequency with which information has been disseminated in the form of national competent authority reports (on incidents evaluated) increased significantly in 2013 and 2014, compared to previous years. It is expected that 2015 will have seen similar, if not higher, levels of action. Moreover, monthly telephone conferences between the Commission and EU member states are taking place to coordinate vigilance matters. These teleconferences also aim at identifying trends and safety signals of concern. The increased coordination and communication between EU member states has significantly increased the number of matters in which national competent authorities can be involved. In some cases, and especially in vigilance reporting, certain manufacturers have been “selected” for special reviews by a so-called task force formed by EU member states.

Such a task force is composed of several national competent authorities with specific interests in a single manufacturer – for example, based on the location of the manufacturer or its main markets. One lead member of the task force coordinates questions and collects information – for example, on the manufacturer’s complaint-handling approach, risk assessment and justification for keeping certain products on the market. Information is provided to the other members of the task force.

This practice has to some extent lessened the burden for manufacturers, who primarily communicate with the lead member rather than with several EU member states concurrently. However, the pressure on manufacturers interacting with a task force is intense and requires the allocation of significant resources. HOW MEDICAL DEVICES MANUFACTURERS SHOULD REACT TO THE NEW ENFORCEMENT LANDSCAPE The most important lesson to learn from recent events is that the current regulatory enforcement landscape requires a different approach towards both national competent authorities (which have become significantly more interested in vigilance reporting) and notified bodies (which are eager to show that they are up to their task). Companies should adopt a communication approach towards notified bodies that largely resembles how they interact with national competent authorities. Previously, manufacturers might have considered notified bodies as a sophisticated type of “service provider”. This is no longer the case, with notified bodies increasingly taking the de facto role of a regulator, and the “practical arrangements” that were common between manufacturers and notified bodies for many years are no longer acceptable.

This is partly a result of national competent authorities being sceptical that the industry generally does not comply with applicable vigilance requirements, and thus leaning on notified bodies. This also means that an otherwise (somewhat) valid complaint from an individual company that it was just following general industry practices is no longer compelling – if it ever was. Therefore, manufacturers should consider changing their previous approach both to general interaction with notified bodies and to how quickly they respond to specific requests. Going forward, manufacturers will need to build more trust, practice more diplomacy, and commit more resources to compliance. Moreover, communication with notified bodies now requires diligence and a healthy level of transparency.

A matter may otherwise unnecessarily escalate to a level it is difficult to come back from (eg, the withdrawal of certificates). In particular, it may often help a manufacturer to place information in an appropriate context, eg, to contextualise vigilance reporting for high-volume products, or to highlight the benefit-risk assessment of a particular product. In vigilance-reporting, companies that have recently engaged with either national competent authorities or notified bodies will know that building trust is key to ensuring a successful outcome from any interaction. However, it takes time to build such trust, and it requires the company to honour any commitments made (however small). Being ahead of the curve, and ensuring that potential gaps are identified and addressed proactively, will often help to gain that crucial trust. Companies may need to commit more resources to compliance in order to address the concerns mentioned above. Staff may need additional training and support to avoid mistakes when under short-term (intense) pressure to answer questions requiring input from multiple departments, or ongoing pressure to increase reporting results and respond to additional questions.

Finally, external advice may help ensure an appropriate balance between providing relevant information and protecting the company’s interests. EDITORIAL POLICY AND SELECTION CRITERIA: NOMINEES HAVE BEEN SELECTED BASED UPON COMPREHENSIVE, INDEPENDENT SURVEY WORK WITH BOTH GENERAL COUNSEL AND LIFE SCIENCES LAWYERS IN PRIVATE PRACTICE WORLDWIDE. ONLY SPECIALISTS WHO HAVE MET INDEPENDENT INTERNATIONAL RESEARCH CRITERIA ARE LISTED .