As coronavirus has continued to spread and cause substantial disruption across Europe, the already halting process of compliance with new EU Medical Device Regulation (MDR) has become more challenging. This mounting pressure has led to EU regulators seeking a delay in enforcement of the MDR by 1-year. In the official statement the Commission will “work on a proposal to postpone the date of application for the Medical Device Regulation (MDR) for one year is ongoing.”
A week has now passed allowing us to digest the news. Here is our take on the matter…
This news confirms that the matter is being considered, but work on getting it approved has only just started. The goal is ultimately to submit this proposal in early April, so that the Parliament and Council can adopt it by the end of May – before the MDR comes into full force.
Apart from the obvious coronavirus severely impacting workflow and hindering progress to ensure MDR compliance, the delay will allow vital devices needed to diagnose and treat coronavirus patients to be available without restraint.
RNI welcomes the delay but would like to emphasise to medical device manufacturers that while the delay may provide some breathing room, it should rather be used to further finetune new implemented procedures.
- Until the amendment, if accepted by the EU parliament, it is business as usual. Manufacturers should continue to work towards a May 26th, 2020 implementation date. A lot of resources and investment have already been poured into being compliant. Stopping this progress now would be counterproductive at this stage. We urge businesses to continue to focus on established timelines so that no nasty surprises crop up.
- Ensuring MDR compliance earlier will give manufacturers a chance to refine their processes. Specifically, for vigilance and post marketing surveillance which have significantly new requirements.
- Use the time wisely to plan new tests for clinical or preclinical data.
What about Brexit? With Boris Johnson’s hands full in dealing with the UK’s management of COVID-19, it has been debated as to whether or not Brexit will be going ahead as planned. It seems that Brexit is undoubtedly immune to the virus and will still be happening. This means the delay to MDR implementation to 2021 would be after the Brexit transition period expires (December 31st, 2020). Consequently, both the MDR and IVDR would never be in force in the UK. The UK government will need to decide whether to adopt UK legislation identical to the MDR and IVDR or have divergent legislation in some form. This matter is still subject to discussion.
It’s safe to say that manufacturers who were scrambling to meet implementation of the new MDR will be overjoyed by this delay. On the other hand, other’s may look back at the investments they’ve made, wondering if they could have saved a little here and there or wondering if the competitive advantage they might have previously had will now disappear. The same goes for manufacturers who spent time and money getting prepared and for those that have been trying to avoid dealing with the MDR. We know it’s going to be a mixed bag.
The MDR has already faced some obstacles getting to where we are. While certain aspects of the MDR are still not ready like Eudamed, the 1-year delay is welcome, and in-fact has been requested by industry bodies for some time now.
RNI will be monitoring the situation closely. Stay tuned for any updates!
For more information do not hesitate to contact us.