There was a lot of demand for the presentation referenced in my previous blog about the MDR and IVDR texts having been agreed because a lot of picture quality was lost in the document embedded in the blog. Thanks very much for all the interest and great feedback!
White Papers and presentation
Also the PDF version that I sent to the people that asked for it was not ideal because some of the pictures were compressed to the point that they were difficult to use, so to give you more options I decided to make the uncompressed presentation document available for download (which was way too big to email to everyone that asked). Feel free to use it – you can download it here (provided that your computer allows downloads from a public Dropbox folder).
I can also recommend looking at the BSI White Papers on the MDR and IVDR and on the MDR specifically (and – disclosure – not only because I was involved in writing them) to get a general picture of things.
Sneak preview: BSI will soon publish another White Paper specifically on the IVDR with better detail on to do items than in my presentation, so watch out for that one.
Remember that everything in the presentation and white papers is still educated guessing and work in progress: the final texts of the regulations are not public yet, but hopefully they will be soon. As soon as I have them without commitment of confidentiality I will post them on this blog and will discuss the final result compared to what we have been guessing would be adopted.
The hateful eight of new EU data protection rules
Also, I have published the first part of an article in two parts in eHealth Law and Policy about the hateful eight referenced in my blog about the new EU General Data Protection Regulation, which you can read in full if you take out a free trial subscription to the journal. The article provides a lot of detail in addition to the blog and embedded presentation. The other part of the article will appear in the next issue (issue 4).
The transition period is still a bit unclear for new devices. Can a new device (not CE marked yet at the time of MDR coming into force) be placed onto the market under the Medical Device Directive (apply for Annex II or V or VI of the MDD certification). Or is the transitional period only for devices that are on the market at the moment the MDR comes into force?
During the transition period (so after the date of entry into force of the MDR) you can place devices on the market under MDD and MDR certificates. MDD certificates can be granted until the end of the transitional period, except that they won’t be valid for more than two years after the end of the transitional period (although this two years may have been extended in the agreed text – there are rumors of this happening). The transitional period is intended to phase all the devices on the market into the new system under the MDR, but this will be a big challenge with the expected limited notified body capacity available.
Only one word for this presentation.