European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee adopted an oral question to the European Commission on IVDR/MDR implementation during their July 10th, 2018 meeting.
The question for oral answer, formulated by the Members of the European Parliament (MEP), asks for the Commission to provide a response on how it plans to avoid disruption in the supply chain and whether there are sufficient resources in place at the three separate Commission DGs that have a role in the support and coordination of the regulatory system, but also at Member State level, to make it all work.
Commission is also asked to provide concrete actions taken to ensure that all aspects of the regulations will be ready by the end of the transition period, including, amongst others, the necessary implementing and delegated acts as well as Notified Body designation.
In addition, Commission is explicitly requested to clarify the Brexit impact on certificates issued by UK Notified Bodies post-March 2019 (effective date of Brexit).
The debate on the question between the Commission and the European Parliament is estimated to take place during the 10 to 13 September 2018 plenary session. The timing is still to be confirmed.
What does this mean to you?
The formulation of the question by MEP of different fractions illustrates the growing concern regarding the timely implementation of the new medical device regulations and the need for more visibility as to what is being done at the highest level to ensure a smooth transition. The coincidence with Brexit has made the implementation even more complex as companies operating out of the UK, having a UK notified body or selling in the UK are faced with the additional complexity to ensure they can still access either the EU market or the UK market.
The responses given by Commission will hopefully shed some light as to how they plan to ensure the new regulations and Brexit do not result in a disruption of the market that would ultimately be detrimental for the patients in need of the devices.
Additional note dated October 25, 2018: Meantime the European Parliament has debated the questions regarding the MDR and IVDR implementation.