europeIt’s the final countdown! Following the trilogue’s agreement on the MDR and IVDR texts the Commission (DG Growth) confirmed at the eHealth Week in Amsterdam last Friday that (probably late) this Wednesday the agreed text of the MDR (and, I assume, IVDR too) will be made public as the signatures required will finally have been placed that day. Stay tuned to this blog for details!

Entry into force slightly later

It was further confirmed that the formal entry into force will be ‘end of this year / beginning of next year’, which looks to be slightly later than I predicted in my last post with a presentation that contained the likely transitional regime.

Expect some surprises and some IMDRF SAMD influence

The Commission said that a lot had happened during the trilogue, so prepare for some surprises.  Surprises will be present for example in the field of regulation of medical devices software and software as medical device (see below for more detail).


Expect some IMDRF SAMD influence

As it was eHealth Week, the Commission speaker addressed the broader EU regulation picture of software under the MDR and IVDR.

The General Safety and Performance Requirements for software in Annex I to both Regulations have been much debated and might contain more detail (I expect in chapter 14 about software) than we have seen so far. Hopefully there will be more detail on cybersecurity, because the EU is starting to lag behind seriously behind the FDA with its regulatory thinking on this subject for medical devices.

A feature to be expected in the final text was possible deletion of the word “standalone” in relation to software, which would mean that software is qualified and classified regardless of its location. This approach would be a radical departure from the current approach under MEDDEV 2.1/6, since this MEDDEV makes a crucial distinction between software embedded on a device and standalone software in step 2 of the flow chart on page 9 that is the core of the MEDDEV. So that’s a pretty significant change in my opinion.

The Commission mentioned the possibility to create dedicated classification rules for software (making it possible that software falls in class III – currently class IIb is the highest for standalone software) and consideration of the risk categorization principles established in the IMDRF software as medical device (SAMD) work item. Finally, the Commission mentioned the possibility of mandatory clinical investigation for certain types of medical software. That would be the logical consequence of the possibility of software falling in class III, but maybe there is more to this statement – we’ll know on Wednesday.

It was mentioned that we can expect more guidance documents on software under the MDR and IVDR, as a mirror group of EU regulators has been set up to work on transposition of results from the IMDRF SAMD working group to EU medical devices law. This is important, as there are rumors that the Commission was planning to get rid of MEDDEVs altogether under the MDR and IVDR. Apparently the rumors turn out to be wrong.

The Commission further said that we can expect an update of MEDDEV 2.1/6 about software this summer. The update will include an updated section on apps and will incorporate thinking from the IMDRF’s SAMD work item, for example definitions developed in that work item.

Medical devices definition

The Commission raised the – in my view very ill considered – proposal to change the scope of the definition of medical device in order to capture every device with an indirect medical purpose in scope of the MDR and IVDR. The Commission speaker reiterated that both the Council and the Commission were opposed to this amendment because it would lead to the situation that lifestyle and well-being apps would be covered by the MDR and IVDR, which is not the intention of the Commission and the Council. Also this was left implicit, I assume that this means that the Parliament amendment – hopefully – did not make it to the final text. But we won’t be sure until Wednesday.

Now the real work begins

When I asked Mr. Hansson of DG Growth afterwards whether he was taking a long vacation now that the regulations’ texts were done, he said that the real work begins now. His unit will start putting in place the draft delegated and implementing acts necessary to make the MDR and IVDR function (e.g. on Eudamed and UDI) and arrange for the underlying technical infrastructure and that will be a lot of work.

Companies in the medical devices field, as I have been saying for some time, will need to prepare, prepare and prepare.