The Council of the European Union has published a second corrigendum for the EU’s Medical Devices Regulation (MDR). With this corrigendum, all Class I devices under the MDD that would be up-classified under the MDR would be able to make use of the soft-transition and thus have up to 4 additional years, until 26 May 2024, to comply to the new regulations in full. The corrigendum first needs to be adopted by the European Parliament to take effect.
Read also our news article regarding the corrigendum to the IVDR 2017/7
This correction would give manufacturers, for whom working with a notified body would be a novel experience, more time to navigate the waters and would reduce possible supply chain disruptions. This change would also release some of the pressure on notified bodies in terms of workload prior to the date of application of 26 May 2020.
If you currently have a class I medical device that would be up classified under the MDR it could be useful to assess the impact this change may have on your transition project. But take note that the formal adoption by the European Parliament still needs to take place.
In the field of In Vitro Diagnostics (IVDs) this corrigendum triggers speculation. Would this be the precursor of an IVDR corrigendum potentially granting IVD-Directive self-certified devices that are up-classified under the IVDR (which is the large majority of IVDs) more time to transition? Time will tell….
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.