On 20 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council came into force, amending the MDR and IVDR. The subject of this amendment is in particular the extension of the transition period for legacy devices placed on the market in accordance with the requirements of the MDD or AIMDD. The amendment has been received in the field with a generally positive reception and much relief by many, but many questions have been raised about the application of the changes in question. Many of these are answered in the European Commission's Q&A document (Extension of the MDR transitional period and removal of the 'sell off' periods. Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices), which was published on 27 March 2023. In addition to the questions and answers that are already apparent to the attentive reader from the text of Regulation 2023/607 itself (possibly in conjunction with other relevant provisions of the MDR), it also clarifies several areas of contention. This article will deal with these.
Co-existence of legacy devices with new devices and affected classification
For example, the document states that for the determination of the end of the transition period (31 December 2027 or 31 December 2028), it is not the current MDD classification that is decisive, but the risk class determined according to the classification rules set out in Annex VIII of the MDR. Furthermore, the practical issue of how a manufacturer should demonstrate compliance with the conditions for the extension of the transition period (e.g. when supplying a device to a third country or participating in a public procurement procedure) is addressed. For these purposes, a written declaration from the manufacturer or a confirmation letter from the notified body will serve. Harmonised models for these documents should be developed. Competent authorities will also be able to issue free sale certificates.
Somewhat unsystematic is the answer to the question of the overlap between legacy devices (medical devices with assessed conformity according to MDD / AIMDD) and new devices (medical devices with assessed conformity according to MDR), which are to replace the legacy devices. The European Commission allows a manufacturer that successfully completes the re-certification of a device under the MDR to market its legacy devices in parallel until the end of the extended transition period. Such an interpretation seems to contradict the terminology of the MDR, which refers to a device that "replaces" a legacy device. It also de facto contradicts the current application practice of the SÚKL (The State Institute for Drug Control, the Czech regulatory authority) requiring that the notification of a new device be made by way of a change to the notification of a legacy device. However, the approach of the European Commission seems to solve the potential problem of manufacturers with stockpiles of legacy devices after recertification is completed and avoids their unnecessary disposal.
Necessary elements of a formal application submitted by a manufacturer
However, the answer to the question concerning the documentation accompanying the recertification application is clearly the most controversial and will therefore be given the most space in this article. According to the European Commission, the application does not have to include technical documentation for each individual device. However, the information submitted with the application must enable the notified body to verify the qualification of the products as devices, their respective classification and the chosen conformity assessment procedure. In view of the fact that the manufacturer must comply with the quality management system (QMS) requirements of the MDR by 26 May 2024 at the latest, the application for re-certification must include the QMS documentation. When submitting the application, the manufacturer should also provide a timetable for the possible submission of individual technical documents and other relevant information. This timetable should be subsequently agreed between the manufacturer and the notified body.
On the one hand, I understand that such a procedure outlined above can prevent undesirable situations where a manufacturer attaches a complete technical documentation to a recertification application, which the notified body will only get to review in, say, two years. The notified body may find a number of non-conformities arising from developments in the meantime, both regulatory (e.g. change of MDCG documents) and technological (change of state of the art). By agreeing a schedule between the manufacturer and the notified body, an even distribution of work over time and an appropriate allocation of resources can also be achieved.
However, the road to hell is often paved with good intentions. In my opinion, the model introduced by the European Commission of gradual submission of documentation will lead to a tendency for many manufacturers to postpone the preparation of individual technical documents and leave their submission to the last minute. This risks delaying the problem of insufficient capacity of notified bodies. At the end of the extended transitional period, a cork will again be created in the form of freshly submitted dossiers which the notified bodies will not be able to assess in time.
For the prepared, or for all?
There is also a partial negation of the principle on which Amendment 2023/607 was based, i.e. that only ready producers can benefit from the extended transitional period. If the interpretation that the application for re-certification does not have to include a complete technical file is widely accepted, this will lead to another undesirable side effect. Indeed, manufacturers who do not intend to convert (some) of their legacy devices to the MDR regime at all, but only want to extend the period during which the legacy devices concerned can be marketed by submitting an application, could ride this wave.
In conclusion, the risk of plugging outlined above can only be avoided by a responsible approach by manufacturers and notified bodies. In the first place, it is important to avoid the mistaken conclusion that a manufacturer can completely avoid the preparation of a technical file before submitting a recertification application. In fact, the technical documentation must be linked to the QMS documentation, which is a mandatory annex to the recertification application. It should also be noted that careful and business-oriented notified bodies will certainly pressure manufacturers to submit the documentation as soon as possible. If manufacturers are not sufficiently prepared at the time of application for re-certification and agree a timetable with the notified body which they are unable to meet subsequently, cooperation with the notified body will not lead to the issue of the desired certificate, but to hitting a wall. Furthermore, it should be noted that according to point 4.3(a) of Annex VII of the MDR, notified bodies are obliged to check the completeness of the application. According to the MDR, the application must be accompanied by technical documentation. A non-legally binding Q&A document can hardly "trump" legally binding provisions that have gone through a proper legislative process. The interpretation of the European Commission may also be corrected subsequently, at which point it may be too late to prepare a complete dossier.
In view of the above, it is therefore clearly recommended to manufacturers not to delay the preparation of the technical documentation and ideally to submit it together with the application for re-certification, as required by the MDR. This is doubly true in the case of medical devices of higher risk classes, as the conformity assessment requires more time.
Author Veronika Moravová
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