On 23 April 2020, the European Parliament and Council approved the European Commission’s proposal to delay the application date of the Medical Device Regulation 2017/745 (the “MDR”) by one year (from 26 May 2020 to 26 May 2021) by adopting New Regulation (EU) 2020/561 (the “New Regulation“).
Unusually, the New Regulation took effect on the date of its publication in the Official Journal of the European Union, i.e., on 24 April 2020. Typically, regulations come into effect the day after publication. However, an accelerated postponement of the MDR was deemed necessary in light of the current pressure on the medical device industry caused by the COVID-19 pandemic. This is expressly recognized in the recitals of the New Regulation:
“The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to Member States and constitutes an immense burden for national authorities, health institutions, Union citizens, and economic operators… Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give necessary medical treatment to patients who are urgently in need of such treatment.
…Given the unprecedented magnitude of the current challenges, and taking into account the complexity of [the MDR], it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as laid down therein.” (Emphasis added.)
The New Regulation also amends Article 59 of the MDR, which allows (i) EU Member State authorities to grant national derogations for placing on the market or putting into service specific medical devices that are not yet CE-marked if “in the interest of public health or patient safety or health”; and (ii) in certain instances, the Commission to extend such derogations to the whole of the EU. The original version of Article 59 was limited to national derogations obtained under the MDR. However, the New Regulation extends the scope of the Article to include national derogations granted under the currently applicable Medical Devices Directives 93/42/EEC and 90/385/EEC. This provides flexibility for the Commission to extend a national derogation granted by a Member State under the existing medical devices rules to the entire EU territory. This essentially means that Article 59 of the MDR has immediate effect, which will be particularly useful as companies quickly try to bring products to the market to combat the COVID-19 pandemic.
As discussed in our previous InsideEULifeSciences blog post, the delay to the MDR will be welcome news to all manufacturers of medical devices intended for the EU market, as well as other economic operators in the supply chain. The postponement of the implementation date will allow companies to deploy resources to address the current pandemic and will give them extra time to become MDR-compliant.
Finally, it is worth noting that the new application date (i.e., 26 May 2021) means that the full applicability of the MDR will fall now outside of the transition period agreed between the UK and the EU. The UK Medicines and Healthcare products Regulatory Agency (the “MHRA”) has confirmed that it is “taking steps to plan for after the end of the transition period” and that “it will provide guidance on this in due course in light of Government decisions required on the future of UK regulation.” The MHRA also confirmed that elements of the MDR have in any event applied directly in UK law since May 2017, meaning medical devices can now be legally placed on the UK market if they are in conformity with the MDR, invoking all relevant requirements.