November 26th , 2017 saw Notified Bodies able to engage with their designated Competent Authority (CA) to apply for a notification status under the EU MD (2017/745) and/or IVD (2017/746) regulations.
A year passed by and Team-NB pauses to reflect on the future outlooks of the medical device industry before the application date of the EU MD Regulation to provide an overview of where Notified Bodies stand in this process.The overview is built to show the progress of Notified Bodies in their quest for designation - NB-Med started to collect information as early as July 2018, gathering the testimonies of Notified Bodies and their application process through a survey – In total, 37 Notified Bodies shared insights on the status and scope of their respective applications.
A synopsis of the survey results showed that:
- A majority of the existing Notified Bodies chose to apply for the new regulations;
- As of July 2018, not all Notified Bodies, despite seeking notification status, had submitted an application;
- Few Notified Bodies were still deciding on whether to apply or not to the new regulations;
- All device scopes described in the MD and IVD Regulations were covered by these applications;
- The majority of Notified Bodies reported a substantial increase of their resources;
By the time the first Joint Assessment occurred (April 2018), discussions had emerged as to the timeframe within which the designation process was being held and whether all candidates NB would be designated on time. It is difficult to determine if all Notify Bodies would indeed become designated under the EU MD Regulation before its application date of May 2020 to conduct audits and certify manufacturers and products.
Stakeholders such as, MD manufacturers and healthcare professionals, worry that an insufficient number of Notified Bodies will be designated on time to start managing the influx of initial MDR application for certification. Doubts persist also on the capacities of Notified Bodies performing assessment under the current applicable Directives (93/42/EEC MD Directive, 90/385/EEC AIMD Directive and 98/79/EC IVD Directive). These doubts are partially due to the increase in expectations of the Joint Assessment Teams for Resource Qualification and the requirements described in the new MD Regulations.Through this communication, Notified Bodies are taking a step forward to address their concerns and clarify the current situation.
The challenges they face include:
- The period of time set from May 2017 to May 2020 for the implementation of the MD Regulations, which they deem insufficient for all stakeholders involved, especially when for Notified Bodies and manufacturers, some crucial details are still the subjects of ongoing discussion;
- Guidance Documents are still missing which prevents a clear interpretation of the specific requirements;
- Unclear process leading to divergences in opinions from the Joint Assessments;
- A lack of harmonization in the interpretations of the Joint Assessment Team and the different Member states;
- A Shortage in capacity with respect to some of the medical device codes;
- The important workload that two legislative frameworks ( MD 2017/745 and IV /2017/746 regulations) running concurrently from May 2020 to May 2024 represents;
Most recognize that they need to be more thorough in the analysis of questions they receive, with respect to the Designation process. It is however obvious that for most of them, it’s being rather optimistic to believe that every single manufacturer and product will have completed its certification under the new MD Regulation by May 2020.
Indeed, newly designated Notified Bodies will have difficulties in assessing and taking certification decisions for all applicants before May 2020 for the following reasons:
- Most Notified Bodies are designated through various steps, and when some of them might be fully designated a few days before or after May 2020, some might be undergoing this process on a longer stretch;
- The time set between the publication on the NANDO database and the application date of the MD regulation ( May 2020) is just too short;
- Notified Bodies applying to the new MD Regulation have been re-hashing their entire resource qualification procedures to be aligned when it comes to the hiring, training, and the development of their resources; the costs additional time and efforts to meet these new requirements seem increasingly limited, yet additional resources is inevitable for most of them and with it, the additional duties to perform ( PSUR, assessment of SSCP);
- An additional workload is on Notified Bodies’ shoulders to anticipate bottlenecks in the approval process overall, which will likely be created by manufacturers of Class IIa to Class III devices, utilizing the extended grace period running until May 2024, for the maintenance of their MDD/AIMD certificates after May 2020. Notified Bodies in order to maintain those currently available certificates, will have to juggle between those and the new product applications under the MD Regulation, making the whole approval process possibly overwhelming;
- Manufacturers of Class I reusable devices and / or Class I software Medical Devices are not subject to an assessment by a Notified Body under the current MD Directives– They will be though under the MD regulation and it’s anticipated that the unfamiliarity of these manufacturers with the application process for certification will call for “uneven” application, taking most notified Bodies by surprise, when the timelines to certify this type of devices is already shrinking as days go by;
At GMED, we have taken these concerns as our highest priority for 2019 and have put together a program in anticipation of our clients’ transition to the EU MD regulations, to ensure the smoothest and most efficient pathway for their success.