With a year to go before the MDR date of application, COCIR has published a series of recommendations. This is an update from the ‘halftime’ assessment published in November last year and the conclusions are not encouraging. COCIR sees very little progress in the last six months. Despite the considerable resources that industry has invested in preparing, there remain key elements of the system that are not yet in place.
While the COCIR statement focusses on the availability and capacity of Notified Bodies and the sustainability of the grace period, it notes that many other essential elements of the Regulation, including necessary guidance, are also underdeveloped or missing. These include the timely set-up of Eudamed, clear guidance on assignment of UDIs, clinical evaluation & investigations, post-market surveillance & vigilance, and the obligations of different economic operators.
In addition, the paper highlights that there will likely be no Harmonised Standards available by the Date of Application. This final point is subject of its own, separate paper.
In conclusion, COCIR says, “If the European Union’s ambition for medical devices are to be realised, the full regulatory framework will have to be in place and functioning. At this moment, it appears that much effort is needed to complete the framework in time. The current delays in implementation make the European Union a less attractive region for investment by medical device manufacturers, and likely increase cost for hospitals and threaten patient access.”
COCIR calls for the Commission and member states to take a pragmatic approach to ensure that the industry and healthcare in the wider sense are not damaged by poor implementation of the regulation.