The Danish Medicines Agency s strategy for medical devices

Transcription

1 låst The Danish Medicines Agency s strategy for medical devices DECEMBER 2016

2 Danish Medicines Agency, 2016 This publication may be freely quoted with appropriate acknowledgement of the source. Images from this publication must not be reused. Danish Medicines Agency Axel Heides Gade Copenhagen S Denmark dkma.dk Language English Version 1.0 Version date December 2016

3 Contents 1 The Danish Medicines Agency s strategy for medical devices 4 2 About medical devices and the tasks of the Danish Medicines Agency 5 3 Strategic challenges 5 4 Objectives and focus areas Develop efficient market surveillance and user safety Support innovation and life science Strengthened collaboration and communication Efficient implementation of new regulations in Denmark Increasing impact on the European agenda 7 5 Overall delivery plan in the strategy period Overview of challenges, focus areas and objectives in relation to medical devices The Danish Medicines Agency s strategy for medical devices 3

4 1 The Danish Medicines Agency s strategy for medical devices Sub-strategy of the Danish Medicines Agency s overall strategy Our mission is to secure effective, safe and accessible medicines and safe medical devices that benefit society. Our vision is to make the Danish Medicines Agency one of Europe s best in class. This means Active dialogue and collaboration value to citizens Quality and on-time delivery Professional expertise and commitment a fantastic place to work! Help boost Denmark as a leading life science nation Driver of European collaboration and a strong international position Our overall strategy for describes how we will become part of Europe s best in class. Specific and cross-functional strategies unfold and clarify the work required to become one of Europe's best in class. We have prepared specific strategies for licensing, pharmacovigilance, availability, control and medical devices. We have also developed cross-functional strategies for competency, quality, IT and communications. This specific strategy describes the present challenges in relation to the Danish Medicines Agency s handling of tasks in the area of medical devices. It also gives a brief account of the focus areas that the Danish Medicines Agency will work with during the strategy period to address these challenges. During the first years of the strategy period, we will primarily consolidate our organisation, with a strong focus on day-to-day operations. At the same time, we will take the steps required to realise our vision of reaching a European best-in-class level. The Danish Medicines Agency s strategy for medical devices 4

5 2 About medical devices and the tasks of the Danish Medicines Agency Medical devices are products, which are primarily used for the prevention, diagnosis, relief or treatment of a disease. Medical devices cover a wide range of products, including glasses, dental crowns, wheelchairs, pacemakers, hip implants and heart-lung machines. The medical device market is growing rapidly, and this development is beneficial to the citizens. It results in new types of treatment, but also more efficient treatment and reduced time spent in hospitals for citizens who have a chronic disease. At the same time, medical devices are an important industry in Denmark with approximately 1,000 Danish companies employing around 33,500 people. Approximately 95% of production is exported. The Danish Medicines Agency administers legislation in this area and is responsible for monitoring the safety of medical devices throughout its life cycle from the first test in the health service and until it is taken off the market. We assess clinical investigations, monitor notified bodies, inspect companies, register companies and products, provide guidance on marketing and carry out market surveillance of medical devices. To provide common standards and support user safety, government regulation of medical devices is increasingly becoming a pan-european issue. 3 Strategic challenges The most important strategic challenges of the Danish Medicines Agency in the strategy period will be to: strengthen user safety simultaneously with growth in the complexity and volume of medical devices ensure an even more efficient exercise of the regulatory function in relation to industry, and strengthen Denmark s position as a life science nation improve our influence in the EU on the path to become a key driver in Europe. Patients and healthcare professionals want safety and security in the use of medical devices. Due to the growth and increasing complexity of medical devices, the Danish Medicines Agency must follow and act on the development. From 2000 to 2015, the number of incidents reported to the Danish Medicines Agency, e.g. errors, failure and defects in medical devices, saw an increase from 237 to 2,414, or almost 1,000%. As a result, the number of cases that The Danish Medicines Agency s strategy for medical devices 5

6 we have to process also increases. This implies a greater need for proactive efforts and enhanced communication. Just like the number of applications for clinical investigations, this development has reached a new record level. Companies increasingly ask us for advice and guidance, which calls for even more efficient task performance, which should be combined with the need for high quality. The medical device area is undergoing rapid expansion. An example is software used both in personal health apps on smartphones and used to diagnose and treat ill people. Under the new EU regulations to be implemented in Denmark, software defined as a medical device must, to a greater extent, be certified by a notified body. Stronger regulation as a result of new EU regulations on medical devices require resources and improved coordination between government authorities to handle the necessary joint assessments of notified bodies, to provide common IT solutions with enhanced data sharing and to cover new medical devices, such as cosmetic products. Through strengthened European commitment and influence in the EU, the Danish Medicines Agency can contribute (even) more actively to the patient safety of Danish citizens, as well as international citizens, and strengthen Denmark's position within life science. 4 Objectives and focus areas To respond to the strategic challenges, priority will be given to the five areas listed below until Develop efficient market surveillance and user safety We will build up knowledge and get an overview to identify trends and risks associated with medical devices, including in vitro diagnostic devices, to ensure efficient market surveillance. The surveillance implies that we react on trends and follow up on problems associated with medical devices at hospitals, in medical practices, in municipalities and other healthcare providers. Data are decisive for a secure and efficient task performance, including the monitoring of patient safety, and the requirements in this field have been strengthened. In the period, the available data must be expanded for the purpose of monitoring the safety related to the use of medical devices. At present, information is available in the professional nationwide clinical quality databases, in the Danish Patient Safety Database (DPSD), at esundhed, in pricing systems and in several other information systems. The new EU regulations will strengthen the common database, EUDAMED, and contribute to improved surveillance of products, clinical investigations etc. In the year 2021, the Danish Medicines Agency has provided the correct data to document and follow the development in errors, failure and defects in medical devices. This will be used as a basis for measuring the quality of the market surveillance. The Danish Medicines Agency s strategy for medical devices 6

7 4.2 Support innovation and life science We will support an optimum framework for the development of innovative medical devices within life science. The Danish Medicines Agency will provide guidance to companies and researchers about the opportunities within the applicable legislation on clinical investigations and access to the market. In the year 2021, the Danish Medicines Agency has, in dialogue with industry, strengthened the regulatory framework and our guidance to ensure efficient and simple implementation of the applicable rules. 4.3 Strengthened collaboration and communication Generally, we will strengthen the communication about medical devices and increase our collaboration with relevant players. In the media, among healthcare professionals and in industry we see misunderstandings and myths about marketing rules and the safety of medical devices. This challenge gains new relevance due to the new regulations and the resulting increased need for information about the rules and the regulation of medical devices and IVD devices. In the year 2021, the Danish Medicines Agency has built up correct knowledge and thereby promoted the user safety of medical devices in close dialogue with and via communication with users, health service parties and patient organisations. 4.4 Efficient implementation of new regulations in Denmark We will make efforts to ensure safe implementation of the new regulations on medical devices and in vitro diagnostic devices, which the EU is expected to adopt in the first half of The regulations will apply three years and five years, respectively, after publication. The regulations will support free trade in the EU and contribute to an efficient single market. At the same time, they will strengthen the protection of EU citizens health and safety related to the use of medical devices, and support innovation. The regulations set new requirements for both national authorities, notified bodies, industry and the collaboration across authorities in Europe. In the year 2021, the Danish Medicines Agency has implemented the new regulations in an efficient and simple way in alliance with the Danish medical device industry and in collaboration with other EU countries. 4.5 Increasing impact on the European agenda Consequently, we must exert influence in the EU working parties, in relation to the Commission and in EU networks to impact the regulation and interpretation of the rules for the benefit of Danish citizens. It is essential that Denmark contributes with resources and strengths in the European collaboration. This is particularly relevant in the control and monitoring of notified bodies and clinical investigations. Medical devices and in vitro diagnostic devices have interfaces to, cosmetics, food products, software, biocides and chemicals etc. We need to define and influence the development within these interfaces and the potential risks and challenges posed. This will strengthen the The Danish Medicines Agency s strategy for medical devices 7

8 safety of medical devices and make it possible to offer guidance to both the health service and industry. In the year 2021, the Danish Medicines Agency is one of the key drivers in Europe defining and influencing the development and strengthening the common safety of medical devices for patients in Denmark and Europe. 5 Overall delivery plan in the strategy period The strategy s objectives and focus areas build on the present approach, and overall it will strengthen the Danish Medicines Agency and help us achieve a leading position in Europe. The implementation of the above efforts will be a considerable and ambitious quality boost that will benefit user safety and the Danish life science industry. The strategy will be translated into local action plans annually that will lead to a number of deliveries over the coming years. The central deliveries in the strategy period is to: establish data that can be used to measure the quality of the market surveillance of medical devices implement the EU regulations on medical devices and in vitro diagnostic devices on the same level as comparable countries in the EU collaboration increase the Danish efforts in the EU collaboration, and be a key driver in selected areas provide guidance on the access to the market in relation to clinical investigations of medical devices enhance dialogue with users, players from the health service and patient organisations. The Danish Medicines Agency s strategy for medical devices 8

9 5.1 Overview of challenges, focus areas and objectives in relation to medical devices The Danish Medicines Agency s strategy for medical devices 9