As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear: the transitional period in the MDR and likely the one in the IVDR is not actually a transitional period for […]
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 […]
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 […]
In my recent post about potential mass extinction in the EU IVD market as a result of the IVDR and the limited number of notified bodies that look to be applying for IVDR status (and the incredulous reactions that I received) I though it would be a good idea to update on notified bodies in […]
It has been sort of hanging over the medical devices market for quite a long time: the TÜV Rheinland case about the PIP breast implants. This case is the direct result of the PIP breast implants scandal, which had a profound influence on the new EU MDR in the making. We had the Advocate General’s opinion […]
With the MDR and IVDR adoption in sight (currently scheduled for Q1 2017) I see a number of developments in the market, all converging on the higher standards that will be imposed under these new regulations. By way of update, there is movement in the dossiers of the MDR and IVDR. The first drafts of the translations […]
You have a lot to look forward to next year unannounced notified body inspections will start (I hope you, your subcontracts and suppliers are prepared – if not, take a look at this instructive MedCert video), we will or will not close the project of the medical devices regulation revision before the elections during the […]
While everybody in the medical devices industry is still reeling from the ENVI vote results (of which we still don’t know what they are in detail because the documents have not been published yet), the Commission finally issued the recommendation on unannounced audits – I was starting to get worried it would never be issued […]
While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint Immediate Action Plan You may remember that as soon as the PIP scandal’s implications became clear, the Commission initiated the Joint Immediate Action […]
While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint Immediate Action Plan You may remember that as soon as the PIP scandal’s implications became clear, the Commission initiated the Joint Immediate Action […]