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 […]
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 […]
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 […]
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 […]
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 […]
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 […]