The time in which the European Medicines Agency did not care about medical devices is over.
EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices.
The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain types of medical devices and IVDs. The Agency is working closely with the EU regulatory network and with stakeholders from the pharmaceutical and medical device industries, including notified bodies, to ensure a smooth transition to the new regulatory framework.
The biggest challenge is currently “to ensure we have the appropriate expertise and resources to adequately carry out these new tasks,” said Guido Rasi, Executive Director of Agency.
This first document developed jointly by EMA and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) in close collaboration with the European Commission, focuses on the stipulation that marketing authorisation applications for medicines with an integral medical device must include the results of the device’s assessment of conformity by a notified body. Approximately 25% centrally authorized medicines include a medical device component, and the majority of these involve an integral device.
EMA will publish further updates to the Q&A document addressing other requirements for various categories of devices, including those made of substances that are systemically absorbed, products which are not clearly defined as medicinal products, known as ‘borderline products’, and in vitro diagnostic tests used to determine patients’ eligibility for a specific medical treatment.
The complexity of regulations correlates with the complexity of products we develop nowadays. The increasing influence of the EMA in the medical device world is a logical consequence. Medical Device manufacturers should learn to understand their notified bodies as well as the EMA better, because EMA is watching them!
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