Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?
Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA
We are now almost one-third of the way into the 3-year transition period for the EU Medical Devices Regulation (2017/745/EU) (MDR).
The MDR has significant economic impact on manufacturers — not just the cost of implementing the new regulations for new products, but ensuring legacy products meet the new requirements, as there is no grandfathering from the current EU Medical Devices Directive (MDD). The MDR has a big impact on distributors and importers, as well as manufacturers. This means that some distributors/importers (Economic Operators) of CE-marked products may cease their involvement under the MDR. The medical device supply chain is quite complex, often with involvement of multiple distributors, from manufacturers to patients. It is a global issue, as it affects all manufacturers/distributors that sell in to the EU.
Notified Bodies under the EU MDR
One of the key pieces of the puzzle that will allow manufacturers to place their products on the EU market under the EU MDR is the designation of Notified Bodies (NBs) to the EU MDR. Currently the Notified Bodies listed on the New Approach Notified and Designated Organisations (NANDO) database are all connected to one or more of the three medical devices directives – Active Implantable Medical Devices Directive (AIMDD); Medical Devices Directive (MDD); and, In Vitro Diagnostic Medical Device Directive (IVDMDD). However, in order to function as NBs under the Medical Devices Regulations (MDR and IVDR 2017/746/EU), they have to be assessed and notified to these regulations. NBs could not submit their applications until November 2017, and we are now in the relatively complex process of joint assessment. 2018 will be the year for assessing NBs to the MDR.
The new joint assessment process and the added burden of new requirements of the MDR on NBs mean that we expect some NBs to reduce product scope or conformity assessment routes offered; some will voluntarily cease medical device activity altogether; and, some may fail the assessment. So, while there are lots of things manufacturers can and should be getting on with, a key step is to assess their NB options and ensure they are ready to go when NBs are ready.
Key questions are:
- Has my current NB signaled its intention to apply for designation under the MDR?
- Is our product portfolio and chosen conformity assessment route still within the scope of my current NB?
- Are we generally satisfied with our NB? Consider key factors such as: audit scheduling; time to review design dossiers; technical files; substantial changes; general level of accessibility; and, responsiveness.
Your Notified Body Options
If the answers to the above questions are yes, and there is no other reason to consider changing NB, we recommend you signal your intention to stay with the current NB, so you are already on their radar for MDR work.
If you conclude that you want to consider changing NB, we recommend that you start now to conduct preliminary research to assess the factors that are important to you. You may have a niche product. You may be in a particular location which means that audits need careful scheduling. The demand for NB time is going to increase over the next few years and already manufacturers are seeing long wait times from their NBs. The challenge is all the greater because NBs and manufacturers also have to manage the transition to ISO13485:2016 and the Medical Device Single Audit Program (MDSAP).
If your company is new to medical devices, or your products are being up-classified from Class I, then it’s critically important to start now to familiarize yourself with how NBs work, and start drawing up a short-list for interview.
If you are intending to change NBs, the timing will be crucial to ensure as little disruption as possible to supplies and to make the most of existing certification timelines. Make sure you control the process to avoid any surprises.
The UK Picture
No discussion of Notified Bodies is complete without mention of the situation of UK NBs, who in the worst-case will not be allowed to act as NBs after the UK exits the EU in March 2019. A lot of things are happening so that the cliff-hanger situation does not arise, and given the size of the UK NB interest, it’s not in anyone’s interests to allow UK NBs to drop out of the system. (Some reports suggest that over 60% of medical devices are CE-marked using certification from a UK NB).
The three possible scenarios include a transitional arrangement for Brexit beyond 2019; a mutual recognition agreement (similar to that with Switzerland or Turkey); and/or, the 5 UK NBs establish themselves in other EU countries. (We understand that 4 of the NBs currently based in the UK have plans to set themselves up as entities registered in other EU countries such as Netherlands, Ireland, and Belgium, while one other UK NB is being absorbed into its Swedish parent.)
What Else Should I be Doing?
Aside from seriously considering your NB situation, manufacturers can and should already be getting on with other key aspects of MDR transition, such as: checking product portfolio against the new classification rules; working out the timeline of transition, based on expiry of MDD certificates and use of the “grace period”; gap analysis on clinical data; adapting technical files to the new required format; preparing for UDI; reviewing labels; auditing distributors, importers, and ARs; reviewing post-market surveillance plans; updating vigilance procedures … the list goes on.
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