medicaldeviceslegal

€ 500 per data subject – a quantification of why GDPR matters

Clients often ask me why they should invest in General Data Protection Regulation (GDPR) compliance so much. For medical devices and medicines regulatory compliance, they get it to an extent. Non-compliant devices carry risk of enforcement, which can lead to them being taken off the market. Devices off the market = collapse of cash flow […]

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 […]

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

Don’t give me Brexit problems, give me Brexit scenarios

At the moment I spend a considerable amount of my lawyering time answering questions concerning Brexit problems. My first question back to the company is: what are your Brexit scenarios? Did you make a plan to cover the scenarios and follow through? Often the answer is “no, we don’t have a plan, because we don’t […]