Application monitoring (AWB)
Post-marketing surveillance (PMA) and its significance for the clinical evaluation of medicinal products and medical devices. Post-marketing surveillance studies (PMAs) are studies that are intended to gather information on the use of authorized or registered medicinal products. Post-marketing surveillance studies are non-interventional trials within the meaning of Section 4 (23) sentence 3 of the German Medicines Act (AMG).
AWB are not subject to approval, but are notified. According to Section 67 (6) (10) AMG, the competent higher federal authority makes the notifications and final reports submitted to it available to the public on the Internet.
The Medical Devices Regulation (EU) 2017/745 (EU MDR 2017/745) also regulates post-market clinical follow-up (PMCF, Annex XIV) and post-market surveillance (PMS, Article 83) for clinical evaluation (Annex XIV, Article 61) via clinical trials (Annex XIV, Articles 62-82). The clinical evidence for PMCF and PMS can be obtained through observational studies in compliance with the regulations.
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