Received 21 June 2019
Decided 8 July 2019
Granted
Request Reference FOI 11/19
Requester Type Individual
National Standards Authority of Ireland (NSAI)

Information relating to methodology for granting CE certification for a medical device and the relevance of whether a similar product (with the same active ingredient) is the subject, or not, of a designation by the Health Product Regulatory Authority (‘HPRA’)