EU Parliament debates questions regarding MDR/IVDR implementation

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), asked 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.
  • 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.
  • A clarification of the Brexit impact on certificates issued by UK Notified Bodies post-March 2019 (effective date of Brexit).

The EU Commissioner for internal market, industry, entrepreneurship and SMEs (Mrs Elżbieta Bieńkowska), told Members of the European Parliament (MEPs) that so far, all relevant legal deadlines established by the regulations have been met and that work is advancing and progressing according to the plans. The Commissioner stated that a lot of resources are being put on the case, both by Commission as well as by the individual Member States. She stated that the notified body designation process is on track with the timely release of designation codes and that no delays have been observed in the assessments of notified bodies that have applied for designation. 34 applications have apparently been submitted to date. The commissioner was even optimistic in stating that the first notified bodies might even be available before the end of this year (2018), a couple of months in advance of the timeline.

Regarding the impact of Brexit, and the fact that certificates issued by UK notified bodies will no longer be valid as of March 29, 2019 if no withdrawal deal is made, the Commissioner assured that the four UK notified bodies have taken actions to adapt to a post-Brexit scenario.

Last, but not least, it was stated that the delivery of the new plan for the implementation of the new medical devices database (EUDAMED) was also on track and all deadlines have been met so far.

The overall conclusion is that they are on track and that there are no deviations from the requirements and deadlines established by Parliament and the Council. So, for now, there is no reason to ring the alarm bell. The Commission will continue to monitor the implementation process in very close and very constant cooperation with the national competent authorities, the Member States and all other stakeholders.

The complete debate can be accessed here.

What does this mean to you?

The responses given by Commission are very optimistic and they are still convinced that everything is going according to plan, yet they failed to convince the Parliament who remains sceptical.

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