Author: Jean Boudaud
The implementation of the new European MDR (2017/745), now in place since May 2021 and IVDR (2017/746) less than a year away, has proven to be a very challenging task for the whole sector.
Whilst significant efforts have been undertaken in the designation of Notified Bodies, availability and capacity for review and support under the new frameworks remain a key challenge for Industry. Let’s have a look at the progress made over the past year.
Update on NB designation
In comparison to the original total number of MDD Notified Bodies (126), only twenty (20) currently have MDR designation.
In the IVD space, where the magnitude of Regulatory changes is even more significant, the number of designated bodies under IVDR is also still vastly insufficient, with only five (5) NBs designated, down from thirty-nine (39) under the old IVDD.
Here is a summary of designation as of 1 July 2021:
Comparing these numbers with our 2020 NB update also illustrates the very slow progress made in the designation process in the last year. This is due to a range of factors that are directly related to the complexity in implementation (scale of requirements and lack of guidance under MDR/IVDR) as well as external factors such as Covid-19 and Brexit (with the removal of UK NBs from eligible Conformity Assessment bodies).
Limitations in the transitional arrangements
During the transition period, Notified Bodies designated to the old Directives (MDD and IVDD) can continue to issue certificates under these schemes until the Date of Application of the new Regulations.
Notified Bodies can then begin to issue certificates to the new regulations (IVDR and MDR) once they have been designated.
After the Date of Application of the Regulations, Notified Bodies are only able to issue certificates to new Regulations. So, in other words, certificates for new Medical Devices can now only be issued against MDR and certificates for IVDs can still be issued under IVDD for a limited time and may have limited validity (especially in situations of Classification changes).
More challenges ahead
Despite the progress achieved over the year in terms of designation of notified bodies under the new MDR and IVDR, concerns remain about the capacity of Notified Bodies, both in certifying products under the new Regulations and in renewing certificates issued under the old Directives.
There is a risk that the validity of existing certificates will gradually expire without being immediately replaced by certificates under the new MDR and IVDR, which could potentially lead to shortages of devices essential for healthcare. This shortage may impact of course devices supplied to Europe but also potentially supply of products in regions where EC certificates are used as equivalent evidence of conformity assessment (e.g., Australia), although most regulators that accept CE certificates have put contingency plans in place.
Clearly, challenges in the transitional implementation of the new Regulations are not over. Beyond the designation process, it is also worth highlighting that cooperation and collaboration in the post-market surveillance and vigilance phases will also affect capacity from all actors involved (both the Regulators and Industry). Let’s also not forget the uncertainty around the operational development of EUDAMED. Following the release of the actor module (see our EUDAMED is Live blog) functional developments are still required for most of the modules that are pivotal to the full implementation of the Regulations.
Navigating the ever-changing Regulations can be perplexing. Our team is here to support you in these challenging times. Reach out to initiate a conversation and see how we can support you.
If you would like further information or are in need of support for these systems, please contact us.