New Malta Medicines Authority’s Email address for Vigilance
We would like to inform our clients that the Maltese Competent Authority, the Malta Medicines Authority (MMA), has introduced a new dedicated email address for vigilance communications. The updated email address is: mdvigilance.medicinesauthority@gov.mt Please be aware that the official Vigilance contact points list published by the European Commission (available at this link) has not yet ...
Auditing of Authorized Representatives
Authorised representatives are an essential link in the chain of ensuring safe and effective medical devices across the European Union. Under the MDR/IVDR, a change that may have escaped many peoples notice is EU REPs are now being supervised by and audited by EU competent authorities to ensure that they are performing their duties adequately. ...
