As the global number of confirmed Coronavirus cases surpasses 1.4 million and deaths exceed 80,000[1],  healthcare professionals, as well as medical device manufacturers and suppliers, are under unprecedented pressure to deliver key medical equipment and technologies in order to fight the  coronavirus pandemic as quickly and effectively as possible.

The European Commission (the “Commission”) and regulators alike are considering how best to ease this burden whilst still guaranteeing the protection of public health, all at a time where business operations in most countries are being reduced or shut down entirely.

To date, these measures include:

1. delaying application of new legislation; and
2. fast-tracking or applying exemptions to legislation.

Medical device regulations

Medical devices in the European Union are currently governed by the Medical Devices Directive[2] (“MDD”), which was implemented in the United Kingdom by the Medical Devices Regulations 2002[3].

New European regulations on medical devices were adopted in April 2017 (“MDR”)[4], but these will not apply fully until the end of a transitional period, which is due to end on 26 May 2020 for general medical devices. However, in light of the Commission’s recent announcement, this date may be delayed.

Postponement

On 25 March 2020, the Commission announced that “work on a proposal to postpone the date of application for the MDR for one year is ongoing”[5]. The Commission’s spokesperson, Stefan De Keersmaecker, provided further explanation of the rationale in a Q&A stating “We are working hard to submit this proposal in early April and we call on Parliament and on Council to adopt it quickly as the deadline for entry into force is at the end of May. This will relieve pressure from national authorities and industry, and it will allow them to focus fully on urgent priorities related to the coronavirus crisis”[6].

Last Friday, 3 April, the Commission published its proposal to amend the MDR to defer the application of certain provisions of the MDR until 26 May 2021[7] and amend some of the transitional provisions over the extended period.

Since the application of the MDR is likely to have a significant impact on manufacturers, this postponement is the Commission’s proactive response to try to support manufacturers and Member States dealing with the current COVID-19 pandemic. It should also allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic (rather than focussing on the new provisions and enhanced regulation imposed by the MDR for many healthcare companies and manufacturers). The Commission’s decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the European Union, whilst also continuing to ensure patient health and safety until the MDR becomes applicable.

The Commission recognises that “shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic.”

The Commissioner of Health and Food Safety, Stella Kyriakides, explained that the “priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must be avoided”[8].

Although the MDR is key to ensure patient safety and increase transparency on medical devices across the European Union, the Commission intends that the currently applicable rules will continue to guarantee the protection of public health.

Emergency national derogation

Under Article 11(13) of the MDD and Article 59 of the MDR, a regulator can authorise medical devices to be placed on the market without completing the relevant conformity assessments (i.e. without a CE mark) where this is “in the interest of the protection of health” (Article 11(13) MDD) or “in the interest of public health or patient safety or health” (Article 59 MDR). Unlike the MDD, the provisions under the MDR allow a regulator’s authorisation to place a product on the market to be applied across the European Union (rather than in individual Member States). The Commission’s proposed amendments to the MDR extend the scope of the right under the MDD. This is likely to have a significant benefit for manufacturers responding to the COVID-19 pandemic, who would no longer need to seek approval from regulators in each Member State – allowing them to offer vitally important medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment (which play a crucial role in fighting the COVID-19 pandemic) across the European Union.

This could be particularly beneficial to regulators that have already applied these national derogation measures – for example  the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has stated it may authorise the supply of non-CE marked devices in the interest of the protection of health during the coronavirus pandemic[9].

In vitro diagnostics regulations

Although the Commission has proposed a postponement of the full implementation of the MDR it has not currently made any amendments in relation to the transition period for the In Vitro Diagnostics Regulation[10], which is due to apply from 26 May 2022.

Conclusion

The coronavirus crisis has created extraordinary circumstances, none of which were anticipated at the time the MDR was drafted. The Commission’s change in approach will hopefully enable the healthcare industry to focus on the task at hand, and ensure that the necessary products that are so urgently needed in these times of crisis can be quickly made available to those in need, and assist in bringing this pandemic to an end.

 

[1] https://www.worldometers.info/coronavirus/

[2] Medical Devices Directive (93/42/EEC)

[3] Medical Devices Regulations 2002 (SI 2002/618)

[4] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.

[5] https://ec.europa.eu/health/sites/health/files/docs/20200325_news_md_en.pdf

[6] https://www.evnia.dk/index.php/news/111-commission-working-on-proposal-to-postpone-mdr-application-date-for-one-year

[7] https://ec.europa.eu/info/sites/info/files/proposal_for_a_regulation_of_the_european_parliament_and_of_the_council_amending_regulation_eu_2017_745_on_medical_devices_as_regards_the_dates_of_application_of_certain_of_its_provisions.pdf

[8] https://www.raps.org/news-and-articles/news-articles/2020/4/european-commission-proposes-to-delay-mdr-by-a-yea

[9] https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak

[10] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.

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