EMA to Publish Scientific Opinions on Medicines Contained in Medical Devices
The European Medicines Agency (EMA) will for the first time begin publishing public assessment reports (PARs) for pharmaceutical and biological medicines used in medical devices, the agency said in an 8 August announcement.
The EU regulatory agency does not, to the consternation of critics, review medical devices. Devices intended for marketing in Europe are instead regulated through the European Conformity (CE) marking system, through which devices are assessed by either the manufacturer or a Notified Body before being allowed on the market.
EMA officials said despite this, the presence of the ancillary medicinal substances in the device places the substance-and the substance alone-under their purview, requiring them to provide a scientific opinion on the substance to the Notified Body. The opinion, "Addresses the quality and safety of the medicinal substances including the clinical benefit/risk profile of the incorporation of the substance into the device," EMA explained.
The agency has already given nine such opinions since 2005, it said in a statement, but until now they had remained unpublished. All future PARs for devices containing ancillary substances will be made publicly available, EMA wrote.