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 the ball – I give you the case of the Netherlands:
Netherlands implementing decree
The Netherlands is putting in place the last bits of its MDR and IVDR implementing legislation with the amended Medical Devices Act in the senate for sign-off (slated for first examination on 14 May) and is currently consulting on the draft implementing decree until 24 May, which contains the juicy substantive bits of the MDR and IVDR policy options to be exercised by the Netherlands (in addition to the surveillance options that I discussed in a recent seminar – up to 10% of turnover in fines possible and additional criminal liability, people!).
The Dutch draft decree provides an interesting insight as to how an EU member state would implement the MDR and IVDR as regards:
- implant card;
- details on reprocessing of single use devices (which ones may not be reprocessed and mandatory procedures for reprocessing);
- details on reprocessing of re-usable invasive devices (requirements and procedures for health institutions engaging in this); and
- labelling of sterile devices.
If these items are important to your company in the Dutch market and you would like to know more or if you need help responding to the consultation, let me know. The consultation ends on 24 May, so any reaction has to be submitted by that date.
Not covered in the decree
There is also a lot not in the implementing decree, like for example what type of in-house developed medical devices and IVDs are not allowed. In fact, the implementing decree does not cover any of the national policy options under the IVDR (not that there are many though).
Also, the decree (as well as the implementing act on which the decree is based) is silent on what every manufacturer, importer and autorised representative wants to know at this point in time: how, where and when can I obtain my Single Registration Number (SRN), and how long will it take? The SRN is mandatory for communication with the Eudamed database and for making a conformity assessment application under the MDR and IVDR, so kind of crucial.