There is no doubt that the coronavirus pandemic has become literally a “panproblem”, i.e. a complication impacting all areas of industry. The brunt of the current situation is being born by the healthcare sector. The crisis is manifesting in different ways, from overstrained healthcare workers, through bans on medical device distribution and medicinal product export to complicated global supplier-customer relations. Apart from the personal protective equipment sector, the medical devices sector is one of the most affected ones. All over the world, manufacturers from automotive and other industries are switching to the emergency production of ventilators and other necessary medical devices. Moreover, the crisis has come at what may be the worst possible moment for the medical technology sector. The hotly debated Regulation on Medical Devices (EU 2017/745 MDR), the implementation of which we discuss in practically every single Newsletter issue, was supposed to take effect on the 26th May 2020.
This much debated date of effect was surrounded by concerns particularly in relation to the readiness of member states, medical institutions, economic subjects and other affected parties for the new provisions brought by the Regulation. In relation to this, the English abbreviation for date of arrival “DoA” was often (with a sense of humour as well as foreboding) read as “Dead on Arrival”. The critical point was and continues to be the capacity of notified subjects, whose appointment as well as supervisory activity are literally paralysed due to movement restrictions within the EU. In the management of the crisis, when all resources must be directed to solving the situation, the change of the legislative network, which is moreover seen by a large part of the expert public as far from ready, would certainly mean another serious destabilising element.
At the literally last minute – on the 3rd April
– then came the event we were all repeatedly assured would not come to pass. The Commission has put forward a proposal to postpone the effect of MDR by one year.
On 17th of April, this proposal was passed by the European Parliament and on 22nd April the entire procedure was then completed by the proposal being passed by the European Council and subsequently published in the Official Journal as No. 2020/561
and the unbelievable became reality.
What changes can we therefore expect?
- A deferral of MDR Regulation effect to 26th May 2021 – this change allows the member states the time to overcome the current pandemic and give them more time to finalise implementation steps.
- A deferral of the repeal of Directives 90/385/EHS and 93/42/EHS – a necessary measure to preserve the effective regulatory framework for medical devices.
- An introduction of the “COVID-19” mechanism – this measure consists of an amendment to Article 59 of the MDR to make it applicable before the rest of the Regulation comes into effect. This article regulates the possibility of marketing medical devices before their conformity assessment has been finalised if they are necessary for the protection of public health or to ensure the medical condition of patients. Duly substantiated requests for such a course of action are appraised by the relevant member state body – in our case the State Institute for Drug Control. Moreover, the Article provides the Commission with a new tool consisting of expanding the marketing approval to the entire EU area. Such a tool could be very useful in the current times.
- The start of the transitional period for supplying medical devices which were marketed prior to the MDR taking effect in accordance with Article 120(4) of the Regulation is also being deferred by a year. However, the date of the transitional period end is not being deferred. This therefore means that the manufacturers will still be able to re-certify devices according to the current directives during the added year, but that the final date for marketing such devices remains to be 25th May 2024. Devices marketed prior to this date can then carry on being supplied in the distribution chain until 27th May 2025.
- The launch of the EUDAMED database is also being deferred by a year. The proposal moves the individual dates for EUDAMED so that EUDAMED could gradually be implemented as originally intended, but a year later. This begs the question of whether the Commission is truly intending to deviate from its plan to launch EUDAMED on the day when the Regulation of Medical Devices in vitro takes effect, as announced at the end of October last year – the so-called Big Bang scenario. Given the date deferral in Article 123(3d) “provision for if the EUDAMED is not ready on time” to 25th May 2021, it is possible that the originally planned schedule of gradual launch will be deferred by one year. The Commission’s stance should be clarified very soon.
The importance of these deferrals cannot be overstated. They will however only solve the issues that were plaguing the Medtech sector prior to the coronavirus crisis if the crisis is overcome quickly enough and it will be possible to focus on finalising the implementation procedures related to the MDR effect. The insufficient capacity of notified subjects in particular continues to hang above the sector as the metaphorical sword of Damocles and threatens to bring another wave of complications. Equally the implementation of MDR into the legislation is still in the initial stages in many member states, which is rather worrying considering the originally expected date of the Regulation taking effect, even though the Regulation will take effect directly, and its implementation should therefore out of principle be less extensive. In the Czech Republic, the debating of laws on medical devices has been postponed for now in relation to the ongoing crisis. At the same time, on the European level a number of implementation documents are yet to be made available. Given the currently unclear prognosis regarding the length of the pandemic it is uncertain how much time there really will be to make up for the neglected preparations. However, the deferral is good news for manufacturers and distributors, as it gives them time to finetune their procedures and troubleshoot all implementation issues.
PharmDr. Jan Honegr, PhD. (email@example.com)
Mgr. Jan Strnad (firstname.lastname@example.org)
Vilímková Dudák & Partners