The new regulations for medical devices and IVDs take the next step to adoption
The medical devices industry has been anticipating the finalization of new regulations for some time. Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have now been published. The regulations will be voted on by the European Council on 7 March 2017. The European Parliament will vote on 20 March 2017. Following these votes, the MDR and IVDR are expected to be formally published in late April or early May. The Regulations will then enter into force in late May or early June of this year. Accordingly, the MDR will become applicable in three years (2020), while the IVDR will become applicable in five years (2022).
You should note the meaning of terms used in the Regulations - ‘entry into force’ is the date when the regulation comes into effect and the transition period starts. ‘Date of application’ reflects the end of the transition period and the repeal of the Active Implantable Medical Devices Directive (AIMMDD), Medical Devices Directive (MDD) and In Vitro Diagnostic Medical Devices Directive (IVDD).
Since the previous version of the text was made public there has been a lot of work on translating the regulation into all the EU languages and resolving inconsistencies within the text and between the translated versions. The last hurdle was to resolve the transitional arrangements – which parts of the MDR apply to products that are placed on the market under valid certificates under the AIMDD, MDD and IVDD after the date of application. It now looks like the requirements for post-market surveillance, vigilance and economic operators from the MDR will apply to these devices.
Are your plans to come into compliance set?
Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.