The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time.
NBs are already submitting their applications to Designating Authorities to be ready for the new IVDR. Nevertheless, the new designation process brings up some unique issues for both manufacturers and NBs.
When compared to the IVD Directive, the IVD Regulation represents a revolutionary change for both NBs and manufacturers. Under the existing Directive, approximately 10-20% of IVDs have been through the certification process involving NBs; this will increase to more than 90% under the new Regulation.
Those who have read the Commission Implementing Regulation EU 2017/2185 (23 November 2017), will have seen how it defined the new scope designation codes representing IVD, and the related scientific/technical competences that NBs must demonstrate to the Designating Authorities. There are now over 80 codes (under the IVDD, there were just 27 NBOG codes), adding a whole new level of complexity.
Although the Implementing Regulation was subject to a public consultation and received a number of proposals for amendments, it was, in my view, published without substantial changes (See MedTech Europe’s comments as well as at the amendments proposed by others).
Given the wider array of IVDs that will require certification, I believe that the NBs’ goal may be to enlarge the range of product certification that they can offer and to prepare for a significant increase in quantity and quality of work. In order to demonstrate their own expertise to Designating Authorities, NBs will need to determine how many product codes will be covered by their expert teams and/or enlist and qualify new experts to cover them – particularly for categories of IVD not previously reviewed by NBs.
The NBOG’s Best Practice Guide 2017-2 Guidance on the Information Required for Conformity Assessment Bodies’ Personnel Involved in Conformity Assessment Activities, endorsed by the Medical Device Coordination Group (MDCG), defines the general criteria and scope designation codes for the qualification of NB personnel.
Following this guideline, I believe the management of the qualification process may be complicated by the number of codes. NBs will need to demonstrate the competence of their experts for each of the products categories.
Moreover, there are currently no published documents or guidelines that give the necessary clarifications about the Implementing Regulation scope designation codes. Under these circumstances, I am concerned that each NB may find its own way to resolve the qualification quagmire. This means that the Designating Authorities could find a less harmonised ground for applications, which might pose challenges to the goal of providing a uniform evaluation of the NBs.
In this context, I think that NBs may adopt mainly two alternative strategies for IVD designation: the faster solution is to submit, as soon as possible, applications for products already covered by IVD Directive designation, and then apply, once the requirements have been better defined, to the Designating Authority for the extension of designation to more IVD codes. The alternative solution is to try to directly extend their competences to support as far as possible the expected needs of the market.
For manufacturers, there is also much work to do, beginning with a gap-analysis of their technical documentation to be ready to fulfil the new IVDR requirements, identify all the codes related to their products, and re-classify their own devices following the new classification rules (to identify the risk class of IVD). This will drive the selection of the correct certification and requirements to apply for conformity assessment and on-market assessment.
This completely new situation may be confusing for manufacturers, particularly those that have not previously needed NB certification. They will have to approach a NB for the first time, with more severe IVDR requirements for the conformity assessment.
Finally, at the end of the transition period to the new IVDR, the challenge for manufacturers will be to identify an adequate number of NBs designated for all the codes specifically linked to their products.
However, during the ongoing designation process, one cannot predict if a sufficient number of NBs will be designated before the date of application of the IVDR and if NBs will cover all the designation codes for IVDs products.
Although this situation needs to be strictly monitored, it only represents a temporary challenge. Considering the time to the end of the transitional period, I am sure that the authorities will identify measures necessary to manage these issues and reassure stakeholders.
 The purpose of the codes is to categorise the fields of expertise of the NBs and thereby designate their scope.