New Year’s Day, a time to navigate the grey divide between past, present and future. Having watched any of the versions of Scrooge during the holiday break will lead you to the question: who is Scrooge in the EU Saga? I guess it may depend on many factors. For me it could well be seen in the light of the EU-MDR.
The ghost of the past
Looking backwards, we are looking into a grim and somewhat dark episode. Not much seems to be happening that will lead to the improvements foreseen when drafting the new EU legislation. The much-expected steering from CAMD and from MDCG, two units supporting the interpretation and implementation of the MDR, were mainly focused on their own roles and parts in setting the wheels in motion. Getting the essence of Notified Body designation processes had already begun in 2017, and 2018 saw the beginning of harmonization in the new MDR JAT teams, performing the Joint Assessments in Teams. Progress was made, in scheduling and performing audits, however, harmonization is questioned given the letters of concern on the subject from the joint Notified Bodies. Something that will need continuous improvement for sure.
A second set of guidance and directions came out, all geared towards clarifying some of the specifics on the UDI, but mainly the basic UDIDI used as metadata parameter in the EUDAMED database that is being built. As such, the guidance, although helpful to manufacturers struggling with the concepts of the various UDI and seemingly conflicting requirements, is helpful, but again primarily geared towards the direct responsibilities of the legislators, in this case the EU Commission.
So, in looking back, guided by ‘the ghost of the past’, authorities have geared up to do the tasks that will help them achieve their principal roles in the new era of EU-MDR.’
The ghost of the present
Today, ‘the ghost of the present’ is showing is another story. A tale of the manufacturers struggling to get on with the implementation, in the absence of much guidance. And without clarity, sometimes in great financial difficulties to get the budget approvals for the needed work to revised dossier, and to up the ante in the clinical domain. But we see them move on, slowly getting their heads around the essentials of the time-critical elements, such as ensuring continued support from their supplier and subcontractors into a more transparent world where trade secrets are protected to a lesser level, or towards getting more specific clinical data to support clinical performance claims, or should we mention the struggles to reach and contact the Notified Bodies to ensure sufficient staff is reserved at their end to get through the tunnel of MDR certification in a timely fashion. But despite the gloom of some of the difficult challenges, you can see manufacturers work in teams inside their organizations, core-teams supporting business units for example. But also, we see them work together to support joint interpretations, and provided suggestions to the legislators to facilitate their implementation guidance. And we see great steps being made in Commission and Member States working with external experts and with experts from Industry and Notified Bodies, to enhance the cooperation in challenging times.
The ghost of the future
One wonders what will be next. The ghost of the future is showing some of what is to come: guidance on clinical evaluation towards the conclusion on the data being sufficient or not; the first Notified Bodies being designated, so the certification work may get started; more applications from existing and new bodies, to enhance the available resources in the Notified Body world; Common Specification on Annex XVI, and perhaps on re-use of single use devices; perhaps even a first product specific Common Specification, on some of the implants; a system to generate Single Registration Numbers, essential for UDI implementation; perhaps a working beta version of EUDAMED; and finally, a corrigendum to remove some inconsistencies from the original text, as well as from some of the translations. With the stakeholders getting back into trust and cooperation modus, we can be assured that these and many more solutions will be found and published in the course of 2019!
Wishing you all a splendid and inspiring year, overcoming the many EU-MDR hurdles you may have been facing!