On 23 April, the Official Journal of the EU (OJEU) published the Regulation (EU) 2020/561 of the European Parliament and of the Council, amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain provisions thereof. In this article, we explain some of the key points of this postponement and the reasons behind this change to the implementation dates.
Image: Screenshot from the Official Journal of the European Union (OJEU) dated 24 April 2020.
Implementation of the new Medical Devices Regulation has been postponed. European health authorities respond to the Covid-19 emergency.
In the wake of the Covid-19 health crisis across the eurozone, health authorities in member states are dealing with a serious emergency, largely due to a shortage of medical supplies on the market. Or, to put it another way, the shortage of medical devices in the eurozone: a category that ranges from very basic items used in healthcare, such as face masks and gloves, to diagnostic tools such as tests, and even complex equipment such as ICU ventilators.
And that means making emergency decisions in the regulatory sphere as well, as we mentioned recently in an article on the Type approval of the Leitat 1 field respirator. National authorities in the eurozone countries, as well as establishing lockdown protocols – which vary considerably from one country to another – have also had to deal with emergencies that have arisen in the provision of healthcare for Covid-19 patients and with the sheer overload on A&E departments.
To this end, they have had to take immediate decisions, such as fast-tracking the approval process for those medical devices designed to curb the pandemic.
A decision marked by the need to ensure that medical devices are always available on the Union market
In addition to dealing with emergency regulatory cases, national and European health authorities have received a number of warnings that have reinforced the decision to grant a postponement.
On the one hand, the shortage of resources and medical supplies, which has far exceeded the authorities’ own forecasts. It is undeniable that many countries were unprepared for a pandemic of this nature: consequently, the crisis has had to be managed as events unfolded.
It is essential that national health systems are strengthened. And we hope that the authorities have learnt that they must have a greater supply of medical devices -and, of course, better equipment and more healthcare staff.
On the other hand, the recommendation from the medical device companies themselves, following an analysis of the steps taken by the sector. At the end of March, The trade associations for medical devices in Europe and the US – AESGP and Medtech, respectively – have already They called on the European Commission to impose a moratorium on the implementation of the new Medical Devices Regulation, having realised that many companies in the sector would not be able to comply with the new regulations in time.
In short, on the one hand, health authorities in the eurozone have found it necessary to stock up on large quantities of medical devices to tackle the pandemic and prepare for future health crises. On the other hand, many companies in the sector have struggled to comply with the new Medical Devices Regulation 2017/745 in time (and therefore, faced with a scenario of potential shortages due to the clear difficulty medical device companies have had in adapting to the new legislation).
The reaction was not long in coming…
The European Commission, the Parliament and the Council have endorsed the postponement
This is the timeline as regards the European institutions:
- The European Commission was the first to take action: on 3 April, it decided to postpone the implementation of the new Medical Devices Regulation (EU) 2017/745 by one year. It then referred its proposal to the Parliament.
- For its part, the European Parliament decided on 17 April to adopt the Commission’s proposal and submit it to the Council.
- On 22 April, it was the European Council that approved the proposal for a postponement.
- The Official Journal of the European Union (OJEU) publishes the Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain provisions thereof.
Following its publication in the Official Journal of the European Union (OJEU), it was the Spanish Agency for Medicines and Health Products (AEMPS) itself that published, in a Information Note, which confirms that the Regulation (EU) 2017/745 on medical devices will apply from 26 May 2021.
And which clearly sets out the reasons why the implementation of the new Regulation 2017/745 on Medical Devices has been postponed:
«The »This postponement responds to the need to ensure the continued availability of medical devices on the Union market, including medical devices that are of vital importance in the context of the COVID-19 outbreak and the resulting public health crisis."
What else do you need to know about the new Medical Devices Regulation?
If you are reading this article, you may be part of one of these companies that has not yet managed to bring its project into line with the new Medical Devices Regulation (2017/745). Or perhaps you have some other queries regarding regulatory affairs related to this sector.
At GTF, we specialise in the regulation of Medical devices. We can provide technical advice on your project to help you interpret the new European legislation correctly. We have a whole range of range of services on medical device regulation, designed to ensure your company is prepared for the day when compliance becomes mandatory.