medicaldeviceslegal

PRRC guidance under MDR and IVDR published

The MDCG has just published its guidance on the PRRC, MDCG 2019-7 “Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC)”. The guidance is largely unsurprising but I would like to highlight some points that are relevant to companies […]

medicaldeviceslegal

Bottleneck of bottlenecks for notified body capacity

People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices and IVDs. This is especially a problem with respect to IVDs, as LRQA is one of the notified bodies traditionally handling a large […]

medicaldeviceslegal

This was not the Corrigendum you were looking for

So, we have had yet another couple of weeks with many things happening, so you may enjoy the two core slides from a recent presentation of mine at the NEN MDR conference in the Netherlands. In addition we had other interesting developments too: more guidance from the MDCG, this time about the scope of device […]