6.

INVITES THE COMMISSION to take the following considerations into account in the course of its future legislative work: — mechanisms are needed to enhance reliability, predictability, speed and transparency in decision-making, and make sure that it is based on scientifically validated data, — the system of risk based classification should be improved (in particular for in vitro diagnostic medical devices and ‘new products’ as appropriate), — clinical data from pre-marketing studies and post-marketing experience (vigilance reports, post-marketing clinical follow-up, European registers) must be collected in a transparent way and to a greater extent in order to provide the clinical evidence which fulfils regulatory purposes and can, where appropriate, assist health technology assessment, whilst fully recognising and respecting national competences for the latter. Consideration should also be given to methods for ensuring that notified bodies are better equipped with the appropriate expertise to analyse such data in a meaningful way, — there is a need for clearer and simpler rules defining the obligations and responsibilities of all economic operators and the role of other stakeholders (in particular national competent authorities and notified bodies), — the development of a modern IT infrastructure for a central and publicly available database must be further pursued with a view to providing key information about medical devices, relevant economic operators, certificates, clinical investigations and field safety corrective actions. In this context, the possibility of introducing a system to improve the traceability of devices, thus enhancing safety, must be studied, — where necessary, clarification should be made regarding the definition of medical devices and the criteria for their classification, — in addition, a simple and rapid mechanism must be set up for accelerated adoption of binding and consistent decisions and the implementation thereof on the determination of products as medical devices and the classification of medical devices in order to address the growing number of ‘borderline’ cases between medical devices and other products subject to different regulatory frameworks (the framework for pharmaceuticals in particular, but also those for cosmetics, aesthetic products, food or biocides), — as regards the oversight of notified bodies, there is a need to continue to improve the harmonised list of criteria to be satisfied before their designation. In particular the designation process should ensure that they are designated only for the assessment of devices or technologies which correspond to their proven expertise and competencies. The process should also address the need to improve monitoring of notified bodies by national authorities in order to ensure an EU-wide comparable and high-level performance of notified bodies, in this context an enhanced European coordination between competent authorities as well as between notified bodies should also be considered, — the vigilance system for medical devices must be further developed in order to allow a coordinated analysis and a rapid and coherent EU-wide response to safety issues, if needed, — it is desirable to consider a European coordination mechanism founded on a clear legal basis and mandate in order to ensure efficient and effective coordination between national authorities while creating a level playing field. Synergies with existing bodies with relevant expertise should be explored when deciding on the mechanisms for such coordination. Consideration should also be given to which activities are best carried out in cooperation between Member States, — as the medical device sector is a global one, a stronger coordination with international partners is desirable in order to ensure that medical devices are manufactured according to high safety requirements worldwide, — there is a need for a sustainable legislative framework for medical devices which ensures safety and promotes innovation, — it should be considered how to address regulatory gaps in the system, for instance in relation to medical devices manufactured utilising non-viable human cells and tissues, — the need for introducing more harmonised provisions relating to the content, presentation and comprehensibility of the instructions for use of medical devices should be further considered.