Author archive for Katarzyna Mizerska

The Medical Devices Coordination Group (MDCG) chaired by the European Commission provides a range of guidance documents to assist...

The UK has left the EU, and the transition period after Brexit comes to an end this year. From...

The second corrigendum to the MDR-Medical Device Regulation was published in the Official Journal of the EU on December...

Unfortunately, we were informed about fake MEDCERT certificates. Please note that these certificates were neither issued by MEDCERT nor...

The European Parliament has accepted the proposal to postpone the transition of MDR – Medical Device Regulation – by...

We are very happy to inform you that MEDCERT has been designated as a Notified Body under the -Medical...

We urgently would like to point out that the preparation for the transfer from the MDD to the MDR...