Category - MDR

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

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 […]

medicaldeviceslegal

What to expect for 2019 with MDR and IVDR implementation?

Remember the CAMD Roadmap (dating back to end 2017) that promised us a roll-out of MDR and IVDR items that were sometimes even marked ‘high priority’ and how that lifted our spirits (at the time)? Remember how this was supplemented with the Rolling Plan, which promised the roll-out of all roll-outs for 2019? I have […]

medicaldeviceslegal

First notified body EU MDR designated!

BSI reports that it has achieved designation as UK notified body for the MDR. So far, it’s the first notified body to appear in the NANDO database with an MDR designation – see here for scope and here that it’s only BSI so far for the MDR (the last link is a dynamic reference to […]

medicaldeviceslegal

MDR and IVDR in 2019: up or out, sink or swim

Happy new year and welcome to 2019, a truly decisive year for the medical devices industry with interests in the EU. If you haven’t spent any time so far getting ahead of events relating to the MDR and IVDR, this is the year that reality will start catching up with you. This year will determine […]

medicaldeviceslegal

MDR/IVDR Implementation: the transition period halfway point

If you are still free this Wednesday afternoon and somehow involved on the medical devices industry in the EU, our seminar that afternoon in Amsterdam is for you as it discusses where we are with the implementation of the MDR and IVDR. We still have a few seats available, so this will be time well […]

medicaldeviceslegal

Bottlenecks, Brexit and stalling CAMD roll-out

With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are. If you are a manufacturer and have just started thinking about this MDR or IVDR thing, you are in a bad place. Maybe you have […]