You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on. After some pretty mysterious statements of Commission officials in public […]
Do you know that feeling that things look far away, but when you think about it are a lot closer than you think? This is the feeling that the first medical devices companies are having because are facing the reality that they might not be in time any more to have a valid CE mark […]
Attentive attendees of my presentations will have remarked in my presentations about economic operators that essential parts of the general Goods Package were being amended and that this may affect companies in the medical devices space. I now present to you Regulation (EU) 1020/2019 of 20 June 2019 on market surveillance and compliance of products and […]
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 […]
Qserve Group and Axon Lawyers (my law firm) are organizing a pop-up mini conference about the new EU Medical Devices (MDR) and IVD Regulations (IVDR) at Qserve’s Boston MA office in the US on 18 July. Qserve’s board member Gert Bos and Axon Lawyers’ partner Erik Vollebregt (that’s me) will provide a six and a […]
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 […]
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 […]
While nothing much comes out at EU level and member states seem to wait until the last moment with implementing legislation (because the people needed for that are caught up in the gridlocked Brussels MDR and IVDR implementation process as a result of structural under-resourcing of medical devices oversight) some member states are really on […]
In several posts on this blog I have discussed the severe impact that the IVDR will have on the IVD industry selling in the EU (just click on IVDR in the tag cloud on the bottom right of the page). My firm has organised multiple seminars and I have spoken about this on more conferences […]
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 […]