Author archive for Katarzyna Mizerska

The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the...

We are pleased to inform you that MEDCERT has been successfully re-designated according to Directives 93/42/EEC (“MDD”) and  90/385/EEC...

We were informed about a fake MEDCERT certificate. Please note that this certificate was neither issued by MEDCERT nor...

The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and...

The European association MedTech Europe has published an overview on symbols, which shall be applied on the medical devices...

From 21 to 24 September, 2019 the RAPS Regulatory Convergence 2019 takes place in Philadelphia, Pennsylvania. You are very...

According to the Regulation 2017/745 (“MDR”), any certificates to Directives 93/42/EEC (“MDD”) and 90/385/EEC (“AIMDD”) shall become invalid on...

The European Medical Device Coordination Group (MDCG) has decided to use Italy’s medtech classification codes (CND) as the basis...

We were informed about fake MEDCERT certificate. Please note that this certificate was neither issued by MEDCERT nor is...