On 6 January 2023, the European Commission adopted a proposal to extend the transition period for the re-certification of so-called legacy devices (medical devices placed on the market on the basis of certificates and declarations of conformity issued under the now repealed Directives 93/42/EEC and 90/385/EEC) under the new European Regulation 2017/745 (MDR). This is in line with the commitment made to EU Health Ministers at the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) last December. The proposal will now have to be examined and possibly adopted by the European Parliament and the Council.
As Commissioner Margaritis Schinas said in a press release, the aim is to prevent shortages of medical devices on the market.
"Our proposal for an extension of the transitional periods for the application of the Medical Devices Regulation will address the risk of shortages of medical devices on the EU market. We will not allow any risk of significant disruption in the supply of various medical devices on the market, which would affect healthcare systems and their ability to provide care to European patients.“ - Margaritis Schinas
However, as described below, achieving the desired outcome depends on the proactive and responsible approach of manufacturers. It should also be pointed out that the proposal contains some problematic provisions which, in my opinion, could be further amended.
Background of the proposal
The MDR was adopted in April 2017 with an originally planned effective date of May 2020. Due to the COVID-19 disease pandemic, the effective date was delayed to May 2021. As the end of the transition period for implementation of the MDR requirements and re-certification approached, nervousness in the field grew. In addition to the hurdles posed by the pandemic, the war in Ukraine and rising energy prices, medical device manufacturers faced the additional challenge of insufficient capacity of notified MDR-designated bodies. In April last year, European parliament highlighted manufacturers' concerns that it was not possible to replace approximately 20,000 certificates in such a short space of time.
It has become evident that if the transitional period is not extended, the continuity of supply of medical devices needed for patient care and the competitiveness of European industry will be threatened. As already mentioned, the Commission has listened to these calls for an extension of the transitional period and promised to make a proposal at the EPSCO meeting. However, there were question marks over what the proposal would look like.
Main changes
Under the proposal, the end of the transition period would be moved from 26 May 2024 to 31 December 2027 or 31 December 2028, depending on the risk class of the medical device. High-risk devices (Class III and most Class IIb implantable devices) would be subject to a shorter transition period ending in 2027, while low- and medium-risk devices would have until the end of 2028 to complete their conformity assessment. In this context, a corresponding extension of the validity of certificates issued before 26 May 2021, i.e. before the MDR effective date, is also proposed.
The proposal will certainly be welcomed by manufacturers of Class III custom-made implantable devices, for which the MDR stipulates a certification obligation, but which was not taken into account during the transitional periods. The proposal now introduces a transition period for this category until 26 May 2026.
If the proposal is approved, distributors could also be relieved, for whom the risk of drawing a short straw in the form of stockpiles of unsaleable medical devices will be eliminated. The Commission is proposing to abolish the deadline for the "sell-off" of legacy devices, which is currently set at 26 May 2025. Legacy devices will therefore be able to be supplied and put into service until the end of their shelf life (expiry date), if set by the manufacturer. The abolition of the sell-off period would also apply to in vitro diagnostic medical devices.
The proposal favors the prepared
While the adoption of the proposal will certainly give the manufacturers concerned a better night's sleep, it can in no way be interpreted as meaning that it is now possible to put one's feet on the table. In fact, only those manufacturers who have implemented a new quality management system in accordance with the MDR by 26 May 2024 at the latest and have submitted a formal application for certification to a notified body designated under the MDR will benefit from the above transitional periods. Subsequently, manufacturers will have to conclude a written contract for certification under the MDR by 26 September 2024 at the latest.
As already mentioned, the capacity of the notified MDR-designated bodies is still insufficient, despite the growing number of such institutions. Some notified bodies are turning away new applicants, others have long response times. The very high cost of certification for some notified bodies, especially from Western Europe, can also be an obstacle for domestic manufacturers. Finding a notified body with available capacity and acceptable costs and concluding a contract with it is thus usually not a matter of days or weeks, but months. For manufacturers who have not prioritised the implementation of the MDR requirements and have not yet initiated the certification process with a notified body, the possible adoption of the proposal should therefore be seen as the last opportunity to change this approach and thus safeguard their future existence and ensure continuity of supply and availability of medical devices for patients.
Overall evaluation of the proposal - the effort is appreciated, but...
I welcome the final form of the proposal, but it cannot be approached uncritically. If it is adopted, sufficient time will be given for the re-certification of medical devices, for only those manufacturers who take a responsible approach to the implementation of the requirements. Stowaways who continue to remain passive will be thrown overboard. On the other hand, the proposal also has a number of more or less significant shortcomings, and it is obvious that it has been stitched up with a hot needle.
The proposal allows for two possibilities when an expired certificate is renewed. The first option is the signing of a contract between the manufacturer and a notified body appointed under the MDR for re-certification. The second option is the granting of an exemption from the conformity assessment by the competent national authority in accordance with Article 59 of the MDR or the procedure under Article 97 of the MDR, whereby the competent national authority may require the manufacturer to carry out the conformity assessment procedure within a specified period of time for a device found to be non-compliant. Several pitfalls arise here. Firstly, it is generally accepted in legal theory that a time limit or a period that has already expired cannot be extended. Furthermore, it should be noted that the granting of exemptions from conformity assessment is the responsibility of the competent national authorities and their validity is limited to the territory of the Member State concerned. It is up to the Member State concerned to decide how to approach the issue - some Member States do not grant exemptions in practice (e.g. the Czech Republic), while others make excessive use of this possibility (e.g. France). However, according to the proposal, contrary to the prohibition of extraterritorial validity of an exemption granted, the exemption would automatically revalidate an expired certificate and the product could thus be traded throughout the EU.
However, even more worrying is the fact that the derogation under Article 97 MDR is usually granted for a limited period of time, in which case the time limit set by the competent national authority to remedy the non-compliance would become meaningless. In fact, the manufacturer would probably lose the incentive to take the appropriate steps to bring the product into conformity with the MDR within the time limit, as he would have a certificate in his hand valid until the end of the extended transitional period. Finally, the tools that Article 97 of the MDR gives to Member States in the area of vigilance (measures to restrict or prohibit the placing on the market of a device or to ensure that a device is withdrawn from the market or recalled) in the event that non-compliance is not rectified within a reasonable period of time could not be applied and would render market surveillance authorities essentially toothless in this respect.
In my opinion, an elegant solution to these problems would be not to allow the possibility of "reviving" expired certificates at all and to allow renewal only until the end of the validity of the relevant certificate, within the framework of an annual surveillance audit carried out by the existing notified body of the manufacturer.
It is also necessary to mention another problematic area of the proposal, which is the issue of proving whether the manufacturer has implemented the quality management system according to Article 10(9) of the MDR by 26 May 2024 at the latest. Although the complete system documentation is to be submitted to the notified body appointed under the MDR before signing the contract with the notified body, the deadline for concluding the contract is set in the proposal until 26 September 2024. At the same time, the fact that the manufacturer has prepared the system documentation does not mean that the quality management system has actually been implemented. A solution is to require an external audit of the quality management system or an assessment of the system documentation by a new notified body appointed under the MDR. From the manufacturers' point of view, the reference to Article 10(9) of the MDR can be fatal, as the requirements of this provision are quite broad and the quality management system has to take into account a number of aspects such as risk management or clinical evaluation according to the MDR (and is thus not a mere implementation of the requirements of ISO 13485 or the introduction of a similar system).
However, this is a first draft and there is still some room for the above shortcomings to be corrected or clarified. I am confident that, thanks to the regulators' discussions with the Commission, some of the problematic areas will be clarified and the final form of the amendment will contribute to a smoother transition to the MDR regime, without risking a reduction in the safety or effectiveness of the devices and putting patients' health at risk.
Author: Veronika Moravová
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