The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostics Directive (IVDD) (98/79/EC) to establish a more robust EU legislative framework and ensure better protection of public health and patient safety.
The new regulations envisage deep changes such as stricter pre-market requirements for higher risk devices, much more prescriptive criteria for the designation of Notified Bodies, stricter rules on clinical evidence and strengthening of post-market surveillance.
The new regulatory framework has a significant impact on Notified Bodies (NBs) as they are required to re-apply to obtain designations by demonstrating compliance with the new requirements. Moreover, under the incoming regulatory framework, many IVDs will require the oversight of notified bodies for the first time.
In this Respect, the European Commission has published a list of codes meant to categorise the fields of expertise of the Notified Bodies and thereby designate their scope. NBs can therefore apply for the designation based on this list of codes.
New challenges for Notified Bodies
Notified Bodies will be audited jointly by the local Competent Authority, representatives of the European Commission and another member state Competent Authority. They are required to demonstrate increased technical expertise in their scope of designation, as well as improved quality management systems. Another key change brought about by the new regulatory framework is the frequency of re-audits, which will occur more regularly and more consistently across all Notified Bodies than now. NBs are therefore under great pressure as demonstrated by the survey data published by The European Association Medical Notified Bodies (TEAM NB) that found that only 11 of its members plan to get designated against IVDR, meaning that 45% of their members will not apply for IVDR status.
Consequences on the transition to the MDR/IVDR
According to data provided by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), there may be more than half a million different devices currently CE marked under the directives that must transition to fully comply with the new regulations, while probably only a limited number of organizations will be available to handle the expected workload in the upcoming transitional years. Data from MedTech Europe suggests that if 11 organizations receive IVDR status, each Notified Body will need to handle 3,200 IVDs. This figure is many times their current workload. The industry is concerned that based on the current investment of resources, Notified Bodies will not be able to certify the vast number of products early enough in the allotted transition period.
Are you ready for the transition to the MDR/IVDR?
Even if a Notified Body decides to apply for designation under the new regulations, it is estimated that designations of Notified Body will take place well into 2018, further reducing the transition period available before May 2020. From the perspective of manufacturers, it is essential to be prepared to face the transitional period and select a designated Notified Body as soon as possible.
With 30 years of experience with EU regulatory affairs, Obelis offers a specific service for Notified Body Selection to manufacturers wishing to find a suitable Notified Body for their devices. If you wish to learn more about the new medical devices regime introduced by New MDR, please do not hesitate to contact us.