The end of the transition period for so-called legacy devices (medical devices provisionally placed on the market on the basis of certificates issued under the MDD and AIMDD) is inexorably approaching and there have been warnings for some time that the deadline of 26 May 2024 is insufficient given the current capacity of notified bodies authorised to certify devices under the MDR. Thus, there is a risk of unavailability of some key medical devices both in healthcare facilities and to patients. At the same time, the entry of innovative medical devices into the EU market is significantly slowed down.
The same concerns were expressed by the Health Ministers at the EPSCO Council meeting on 14 June 2022, where they called on the Medical Devices Coordination Group (MDCG) to urgently propose the necessary steps to eliminate the risks of major unavailability of medical devices on the EU market. The MDCG has presented a total of 19 non-legislative measures described in the MDCG 2022-14 document. Among other things, a revision of MDCG 2019-6 was proposed to remove a barrier to the employment of skilled workers in the requirements for notified bodies. Another MDCG document 2022-17 then contains recommendations for hybrid audits (combined MDD and MDR audits). Unfortunately, in the meantime, non-legislative measures have proven insufficient to avert the risk of unavailability of medical devices on the EU market. The only possible solution now appears to be a legislative change to the MDR itself.
Conclusions of the EPSCO meeting
The issue was discussed in detail by the EU Health Ministers at the EPSCO Council meeting on 9 December 2022, where the European Commission's representative, the European Commissioner for Health and Food Safety, Stella Kyriakides, announced that the Commission had listened to the concerns of the Member States and was bringing forward a proposal for legislative modification of the MDR, a brief draft of which she presented at the meeting. The concrete text of the proposal should be published and subsequently adopted after the New Year.
In this context, on the day of the EPSCO Council meeting, the MDCG 2022-18 document was also released, applying Article 97 of the MDR to legacy devices for which the MDD or AIMDD certificate has expired. The article in question states that if a medical device is not in compliance with the MDR but nevertheless does not pose an unacceptable risk to the health or safety of patients, the supervisory authority shall request the relevant manufacturer to remedy the non-compliance within a reasonable period of time clearly specified by the manufacturer. The purpose of this MDCG document is to provide a basis for the consistent application of Article 97 of the MDR in situations where non-compliance with the MDR consists precisely in the expiry of the necessary certificate issued under the relevant Directive. According to the document, the application of Article 97 of the MDR should be a temporary solution to avoid disruption of the supply of critical equipment to the EU market.
End of the extended transition period linked to risk classes
The Commission's proposal extends the transitional period according to the risk classes of the assets concerned. The aim of the proposal is to strengthen the continuous certification under the MDR and to avoid that all manufacturers seek a new certificate at the same time, which could paralyse the whole system. For the higher risk classes, namely III and IIb, the end of the deadline is set at 26 May 2027, while for the lower risk classes, i.e. Class I (Is, Im and Ir) and IIa, it is exactly one year later, i.e. 26 May 2028.
The transitional provision contained in Article 120(4) of the MDR also speaks of a deadline for the sell-off of legacy devices, i.e. the date of termination of their legal supply on the market or entry into service. The time limit for the sell-off of legacy devices will be completely removed from the MDR under the Commission's proposal and sell-off will be possible until the expiry of the devices concerned. This is a very interesting proposal, especially for devices that do not have an expiry date.
Commission proposal offers hope, but only for prepared producers, it will not help others
However, the extension of the transitional period is not unconditional according to the proposal. Fortunately, the European Commission has learnt from the recent past, which has clearly shown us that a simple postponement in an attempt to accommodate manufacturers is completely counterproductive. The majority of the field saw such a postponement as further room for lethargic foot-dragging, and the situation has not improved much in the meantime.
However, a condition for the applicability of the current proposal is that the manufacturer has implemented a quality management system according to the MDR, created new documentation according to the MDR and started the process of recertification with the notified body. The manufacturer must achieve all of this by the original deadline of 26 May 2024 at the latest, otherwise there is no delay.
There has been no word yet on what exactly the Commission considers to be the point at which recertification under the MDR will begin, and we will have to wait for the publication of the official text of the amending regulation. We hope, however, that the Commission will make this requirement sufficiently specific, as in the practice of notified bodies the question of the official start of the certification process is approached quite differently. Another prerequisite for the extension of the deadline is that the medical device in question does not present any unacceptable risk to the health and safety of persons and has not undergone significant changes in design or intended purpose within the meaning of Article 120(3) of the MDR.
The lifeline offered by the Commission's proposal is therefore exclusively for proactive producers who are prevented from completing certification early by objective obstacles. It is therefore not advisable to slacken efforts to achieve timely certification under the MDR, quite the contrary.
Author Aneta Jaroschyová