The European Commission’s Medical Device Coordination Group (MDCG) has published long-awaited guidance, MDCG 2020-16, that explains how to classify products for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR, 2017/746). The IVDR is replacing the classification system from the In Vitro Diagnostics Directive (IVDD, 98/79/EC) with a risk-based system, which will require the reclassification…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published on its website full details of how the device registration system for the UK will operate post-Brexit, from 1 January 2021. As already known, only UK entities will be allowed to make the device registrations, these being either UK device manufacturers, UK Responsible Persons…
