On April 3rd, 2020 the European Commission proposed a one-year delay of the Medical Devices Regulation (MDR) to the European Parliament and Council. Originally the Date of Application (DoA) was set on May 26th, 2020, but would move to May 26th 2021 according to the EC proposal.
The current COVID-19 pandemic is the primary driver for this proposed delay. The COVID-19 crisis has had several effects on the medical devices community:
- There are sudden shortages of devices and other products. National authorities, healthcare providers, EU citizens and industry should now focus on making more devices available, instead of the transition to the MDR;
- Notified Bodies cannot do on-site audits and their current way of working is affected because staff must work from home, or are ill;
- Some products may not be certified for commercial reasons to the MDR. This could lead to some disruptions in the continuity of supply. This would have been a problem anyway, but it may be better not to have this potential risk coincide with other shortages.
Delay of DoA: one year
It is now proposed to delay the MDR Date of Application (DoA) by one year. Until May 26th, 2021 devices can still be placed on the market under the current Medical Device Directives, new MDD and AIMDD certificates can be issued and existing certificates can be renewed.
However, this one-year delay does not move other timelines, for example:
- The so-called “grace period” – the period during which devices may still rely on valid certificates issued under the current Directives – still ends on May 26th, 2024.
- The dates by which the UDI must be on the label of an MDR-certified device have not changed.
- The application date of the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) has not changed.
Consequences of this delay
The biggest effect of this delay is that it takes a lot of pressure off, at a moment when all systems are stressed beyond their maximum capacity. This will help all parties involved in focusing on the continuity of supply of devices.
This delay also means that it is still possible to start clinical studies under the current Directives before May 26, 2021, and continue them after that date. Reporting of serious adverse events must be done according to MDR requirements starting from the new DoA.
The Mutual Recognition Agreement with Switzerland regarding the MDD and AIMDD will remain in place for one year longer. This will give politicians an extra period to settle this issue, while affected industry has more time to reorganize how they place their devices on the EU market. The same goes for Turkey. So far the position of the UK (Brexit) is not clear, although it still appears that the MDR and IVDR will both be implemented in the UK simultaneously with the EU.
With only three years from the DoA and the end of the Grace Period, there may be higher pressure regarding the availability of Notified Bodies. That increased demand will collide with the DoA of the IVDR. Therefore industry may expect some congestion for audits.
Error or problem?
Article 120(3) of the MDR is not addressed in the proposed DoA delay. This article covers the applicability of MDR requirements for legacy devices (including post-market surveillance or PMS, market surveillance, vigilance, registration of economic operators and devices) as well as the relevance of “significant changes in the design and intended purpose” for devices maintaining CE Mark certification under the current Directives.
One can only guess why this is. If the intention of this delay proposal has been to “search and replace” 2020 by 2021, they may have overlooked that the second corrigendum changed the original wording – “date of application” – to “26 May 2020.” It appears that this should be considered an error, because it would create a very complex situation. For example, on the one hand new certificates can still be issued under the current Directives, but at the same time significant changes to device design or intended purpose would not be possible. Emergo is therefore of the opinion that it should for now be presumed that this omission will be edited over the coming days.
Conclusion: Refocus on availability of medical devices
The proposed delay will relieve the pressure from the process of making and keeping devices available. But that will only work if this proposal is accepted by the European Parliament and Council. This will not be known by the end of April. Until then all involved should keep preparing for the MDR becoming applicable on May 26th.
Learn more about European MDR compliance issues at Emergo by UL: