Reporting requirements for marketingauthorisation holders. Medical devices are products or equipment intended generally for a medical use. They are regulated by national competent authorities, but the european medicines agency ema is also involved in the assessment of certain categories of medical device under european union eu legislation medical devices in the eu have to undergo a conformity assessment to demonstrate that they meet legal. This functionality is only available for trials with a eudract protocol, but not for paediatric studies in scope of article 45 of the paediatric regulation. An exponential moving average ema is a type of moving average that is similar to a simple moving average, except. The eu clinical trials register contains information on clinical trials with in vestigator sites in the eea. Eudrapharm is the community database of authorised medicinal products. From that date companies no longer need to notify ema for centrally authorised products or national competent authorities for nationally authorised products of changes to the qppv or psmf data by submitting a type ia in variation. The eu clinical trials register offers the option to save a specific search or an advanced search query as a really simple syndication rss feed.
Monitoring of medical literature and the entry of relevant. Article 27 of regulation ec 7262004 states the following. Ema has published a booklet describing the journey of a medicine for human use authorised through ema, from initial research to discussions on patient access to medicines across the eu. Ema, together with the pharmaceutical industry and the eu member states, has launched its enhanced fasttrack monitoring system to help prevent and mitigate supply issues with crucial medicines used for treating patients with covid19. Marketingauthorisation holders must submit the results of studies on authorised medicines conducted in children to the european medicines agency ema or to national competent authorities in the european union eu. The eu clinical trials register provides a free and accurate search of clinical trials in european union member states and the european economic area.