On September 1, 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new guidance how medical devices will be regulated post-Brexit as of January 1, 2021.… Read More
New UKCA mark after Brexit
Month: September 2020
EUDAMED economic operator registration module available as of December 2020
Last year, the European Commission has announced that EUDAMED 3 as one central aspect for the implementation of important medical devices regulation (MDR) and IVD regulation (IVDR) mechanisms, will not… Read More
Guidance checklist for manufacturers of reusable and resterilizable medical devices
The European Commission has issued a document that is highly relevant for manufacturers of reusable and resterilizable medical devices. You can find this document here. The background for issuing this… Read More