EU MDR Deadline to be Postponed

EU MDR Deadline to be PostponedWhat Does It Mean For The Medtech Industry?With the EU MDR deadline postponed, MedTech Summit looks at what it means for the medtech industry.Contents

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On Friday the 3rd of April 2020, the EU Commission released the highly anticipated statement regarding the postponement of the EU Medical Device Regulation (MDR) date of application. Just two weeks later, on 17th of April, European Parliament voted on this with 693 in favour, with just 1 vote against it (and 2 abstained), advancing this proposal to the European Council for final sign-off. So long as this is law before the original MDR date of application, the new deadline will be the 26th May 2021 offering Medical Device, Software and Combination Product manufacturers one more year to ensure their processes and products meet the increasingly stringent regulatory requirements.

"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,"

Stefan de Keersmaecker, European Commission spokesperson

The widespread and ongoing need for ventilators, assistive devices, technology and vaccines were a primary reason for the extension of the EU MDR. As Vice-President for Promoting our European Way of Life, Margaritis Schinas, says:

“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.”

Vice-President for Promoting our European Way of Life, Margaritis Schinas

The recognition of the necessity to accelerate certain products to market highlights a key challenge of the increasingly stringent regulations which, at this moment in time, would increase timelines from concept to market and delay patients from receiving potentially life-changing treatments.Regulators in some countries have already relaxed regulations in order to get devices onto the market quickly in the effort to reduce the devastation of COVID-19, and the delay of the EU MDR will bring further relief.Under the increasing social and organisational pressures brought about by this global pandemic, and with many teams dispersed as some tackle the corona virus on the front-line and others do their part remotely, the industry consensus it that this postponement was absolutely necessary in light of these current circumstances.Beyond freeing up resources to help combat COVID-19, what is hoped is that this additional year will increase awareness and provide the opportunity for manufacturers producing patient-crucial (but not necessarily profitable) devices to recognise the patient value of their product, and that some sort of regulatory oversight will be developed across Europe to ensure minimal product fallout across the sector.

COVID-19

More time. More products?

In the MedTech 2020: EU MDR & IVDR Compliance Survey only 22% of companies indicated that they would be extending their MDD certificate for all of their products, which, with only a small number of EU MDR certified products on the market at present, indicates that a significantly large proportion of products may be dropped due to the new regulations.

What Does It Mean For The Medtech Industry?

Medical Device Manufacturers

Medical device, combination product and software manufacturers will have more time to prepare for the EU MDR compliance deadline. This increases the time opportunity for companies to survive the new regulations and maintain healthy competition.

Our recent EU MDR & IVDR Compliance report showed 67% of respondents were planning on using their entire MDD certificate time to get EU MDR ready. The one year extension gives Medical Device manufacturers more time to secure more products under EU MDD extension certificates and/or EU MDR CE marking, for products that may have otherwise been dropped.

Industry will have more time to seek further clarification on regulations, attend events, work with peers and benchmark with guidance.

Notified Bodies

With a limited number of designated Notified Bodies under the EU MDR, this extension provides a lifeline for many Notified Bodies that had yet to achieve this status.

With vast numbers of products being submitted for review as the industry compete to meet the regulations, this will give Notified Bodies additional time to process applications and provide the necessary feedback to ensure more products achieve timely compliance.

A chance to expand and take on new products? Currently it is hard to predict how many Notified Bodies will be designated by May 2021, however an ideal picture would see those designated processing applications efficiently and expanding to take on new clients and product types.

Competent Authorities

Competent Authorities will now have more time to process more product submissions. This should reduce the fallout of products when the EU MDR date of application comes in to play.

The EU Commission

The deadline postponement allows for more time for the EU Commission to address industry concerns and confusion. E.g. An opportunity to providing additional guidance documents for manufacturers to follow and implement.

Patients

Originally the EU Commission brought in the new medical device regulations "to ensure better protection of public health and patient safety". Ultimately this was deemed necessary to protect end users following some major adverse events that highlighted flaws in the previous regulations. However, the extension of the EU MDR is just as crucial to public health and patient safety as it is to manufacturers, as it:

Increases the likelihood of compliance for a larger number of product lines that patients heavily rely upon.
Provides more time for the industry to assess the medical device landscape and identify gaps in the market to ensure patients have the products they need.

Timing Is EverythingAt a time of unprecedented change and just weeks before the original deadline was set to kick-in, this postponement could not have come at a more crucial time.Our EU MDR & IVDR Compliance survey carried out earlier this year showed that only 17% of respondents felt their company was 'fully prepared' for EU MDR implementation, with reasons given for the lack of readiness including; a necessity for more guidance documents; Notified Body uncertainty; and timelines. See the full report here.This showcases that for many companies in the industry working tirelessly under the weight of this looming regulatory deadline, alongside challenges like BREXIT and COVID-19, the deadline postponement could not have come at a more pivotal time.