Status quo of ‘delegated & implementing acts’
Since the new EU Regulation on medical devices (MDR) came into force on 25 May 2017, the impact assessment phase has begun. Many questions remain unanswered with regard to the implementation of the basic act, in particular with regard to delegated and implementing acts.
The MDR constitutes a legal framework which must be developed by the enactment of 43 further specific acts, 11 of which are delegated and 32 of which are implementing acts. 8 implementing acts require urgent enactment. In respect of these, all that exists so far are some initial drafts, for example on ‘codes for notified bodies’ and ‘Appendix XVI products’ (an index of product groups that do not have a medical purpose).
The EU Commission has published a ‘draft implementing regulation’ to deal with this.
The ‘National Working Group for the Implementation of the MDR and IVDR’ (NAKI for short), established by the Federal Ministry of Health (BMG), has set out to solve the problems which have been cropping up in the implementation of the MDR and generate practical knowledge and support in the implementation of the MDR and IVDR. The results are forwarded to the EU Commission. Currently the various individual subgroups of NAKI are meeting. Their findings will be discussed and agreed at the next NAKI conference on 1 February 2018, and subsequently published on the home page of the BMG.
The BMG constitutes the link between the national and European levels, being a voting member of the European ‘Coordination Group for Medical Devices’ (Article 103 of the MDR). As from 26 November 2017, the job of the Coordination Group is to deal with all the inconsistencies that have accumulated at national level. The first working groups are expected to get started after constitution of the Coordination Group for Medical Devices some time in 2018. The first key topics will be nanomaterials and non-medical devices.
As for ensuring legal compliance in the light of the MDR, that is something for which the economic operators, above all manufacturers of medical devices, will have to wait a little longer. The road to the enactment of delegated and implementing acts looks as if it may be a long one. Reuschlaw will continue to follow the development of the MDR via the specific acts and provide updates on the state of development.
[December 12th, 2017]