The much-dreaded date of 26 May 2020 is now only a matter of weeks away and with that, a new phase of the transition towards a full MDR implementation will begin. For those manufacturers that have decided or have been forced by the circumstances to certify their devices under the new regulation, it will be a deep dive into an unexplored territory; for those that will temporarily maintain their certificates issued under one of the directives, it will be a ride on a foggy road; for most a combination of both.
The so-called “soft transition period” (or “grace period” as some call it) will begin. Certificate issued under one of the directives will continue to be valid until their natural expiration date or for a maximum of 4 years, whichever comes first. The second corrigendum, published and approved just a few months ago, also extended this transition period to the class I reusable surgical instruments and all those class I devices that will fall in a higher risk class under the MDR (for example certain substance-based devices or SaMD), as long as covered by a Declaration of Conformity issued before the date of application. This Declaration of Conformity will be issued under one of the directives however it might be worth declaring also compliance with some of the provisions of the MDR, specifically article 120(3).
However, for manufacturers that intend to keep devices on the market under this transitional provision, it will not be business as usual. As described in article 120(3), they will have to comply to the MDR requirements related to vigilance, registration of devices, registration of economic operators and post-market surveillance (which, although it is a matter still heavily debated, should include the appointment of a person responsible for regulatory compliance). Making sure those requirements are met will involve (and certainly is already involving) a significant effort for manufacturers and a lot of creative thinking and adaptability. The implementation of the MDR infrastructure is still a work in progress and therefore manufacturers are aiming at a moving target. In May EUDAMED will not be up and running however from Tuesday 26th MDR-relevant data related to devices and economic operators will have to be recorded for a future retrospective upload into EUDAMED. Despite this effort, the validity of the certificate could be jeopardised should manufacturers need to introduce a significant change to the design or intended purpose of their devices. This is the last, and certainly not the clearest, condition to be met in order to make use of the soft transition period.
What do we know so far about this condition? Not much, as not a lot of information, has been coming from Brussels on this matter so far.
The text of the MDR does not include a definition of “significant change”, which is not surprising if you are reasonably familiar with the way the regulation is written. Without a clear definition, this is another area that remains open to interpretation and in urgent need of some clear guidance.
Looking at the bright side for a moment, there are a few things we know about the handling of changes under article 120(3) and it is worth listing them out. We know that the text of the MDR reads “provided there are no significant changes in the design and intended purpose” but the intent is to prevent changes to design or intended purpose. We know that manufacturers will be allowed to change the intended purpose of their devices, as long as the change goes in the direction of limiting the original intended purpose. And we know that manufacturers will be able to implement corrective actions involving a design change as long this is done under the approval of a competent authority, for example as part of a FSCA. All this was made clear quite soon by CAMD in their FAQ document published in early 2018.
This same document also confirms that Notified Bodies which issued the certificates will continue to be responsible for the appropriate surveillance (and therefor to handle changes), despite their designation under MDD/AIMDD becoming void on May 26th. Notified Bodies will have this task regardless of whether or not they have applied for an MDR designation (MDCG 2019-10). However, if your Notified Body has not applied it might be safe to have a frank and open conversation with them to understand their plans: if they decided to drop the CE marking business altogether you could find yourself in an even more challenging situation.
That is as much as we officially know. The MDCG has a guidance document planned on the matter of changes under article 120 and, although there is some work going on, the possible publication date is not clear. Notified Bodies (with the exclusion of GMED) have not been forthcoming either in providing guidance on this matter.
MedTech Europe was the first to put out a clear proposal, including some useful decision trees, in their position paper published in October 2018. The document suggests an approach (largely based on the NBOG’s Best Practice Guide 2014-3) for identifying whether a change should be classified as significant, therefore not allowed under the transitional provisions, or non-significant, therefore manageable under the umbrella of a directive certificate.
GMED followed a few months later, first and only Notified Body so far to express a clear position on the matter in a guidance document. The document is well aligned with the MedTech Europe’s with a few more details in some of the decision charts (in particular the software one).
As mentioned above, MDCG is working on a guidance document on changes under article 120. We know an initial draft was prepared and was circulated for comments (for stakeholder’s eyes only). Word has it that the document is (at least in its current status) quite well aligned with MedTech Europe’s and GMED’s and therefore with the NBOG guidance on changes, perhaps with a slightly more liberal approach.
So what can we expect, assuming the direction will not change significantly? Some changes that could be particularly critical for manufacturers should be possible. Those are for example extensions of the shelf life (if the validation method/protocol was previously approved by Notified Body), changes of materials (as long as they continue to meet the same specifications) or changes aimed at fixing software bugs, updating security or modifying to the appearance of the user interface (if there is no impact to the diagnosis or treatment delivered).
On the other hand, changes involving medicinal substances or materials of animal origin, are likely to be considered significant. And so is, for example, any change that might require additional clinical or usability data in order to confirm safety and performance or that introduce new hazards.
Quite nebulous is the handling of administrative changes or QMS change. Those are not specifically and directly mentioned in article 120(3), however, manufacturers will certainly be in need to implement some of those. It could be for example a change of name or address or the introduction of a new subcontractor or a new EU representative. Those are and will continue to be, very common and if certain flexibility to implement those is not applied the whole intent of the soft transition period could be hindered. At the moment the feeling is that common sense will be applied to this matter and some margin of manoeuvre will be left to manufacturers. However so far there are no clear directions for Notified Body regarding the way those changes will have to be handled. Will they have to be assessed and approved prior to implementation, as part of the regular surveillance audits or will it be a case by case decision? Since Notified Body will be no longer designated to issue or re-issue certificates, will the changes be reflected in any official document (an addendum to the certificates, an official Notified Body letter)? We really don’t know and probably Notified Bodies don’t know it themselves.
As for many other MDR-related topics, the advice is to work now on the changes that can still be implemented under the directives. Those are not many, given the limited time available, and certainly do not include changes to class III devices but there might be something for lower-risk devices that can be cleared before May 26th. The second step should be to start planning the foreseeable changes (which are clearly not the vast majority) and open a discussion with your Notified Body. This should be started as soon as possible: Notified Bodies too are under enormous pressure and most of us have experienced directly how that impact their availability and response time. They might not have all the answers yet but if faced with the problem they should be able to give at least some general tentative direction. It is not ideal but when you are navigating in foggy weather you have to get used to the uncertainty. Finding the way in poor visibility is becoming everybody’s job nowadays but hopefully, we will slowly see the light; and as Jack Kerouac said: “when the fog's over and the stars and the moon come out at night it'll be a beautiful sight”.
We are all looking forward to that beautiful sight.