Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device regulation is set by the European Commission and it is applicable to all EU member states. Similar to device classification in the U.S., in the EU, medical devices are organized into three categories – low-, medium-, and high-risk – based on the product’s perceived risk.
In the EU, manufacturers of low-risk medical devices can self-certify their product. Manufacturers must comply with the applicable regulations, but once that is accomplished, they simply notify the competent authority of the country they are located in of their device and they are good to go. The competent authority can choose to inspect the manufacturer, so it is always important to be sure you are in compliance with all applicable rules and regulations. If you are unsure and want to confirm that you are fully compliant, it is always a good idea to have a third-party consultant take a look at your product with a fresh set of eyes to make sure there are no surprises if and when you are inspected.
The Commission has outsourced the regulation of medium- and high-risk devices to notified bodies, which are organizations designated to assess the device’s compliance with the regulations before they are placed on the market. To become a notified body, the organization must qualify to apply and then be approved by the competent authority. When seeking approval of a medium- or high-risk medical device, manufacturers must send their technical documentation to a notified body, which will conduct the review and determine if all essential requirements have been met for a certification to be awarded. From there, the notified body will issue a formal compliance certificate, indicating that the medical device is approved for placing on the market in the EU.
In 2017, the medical device regulation (MDR) was published in the EU to take the place of the medical device directive (MD directive or directive), which is the ‘New Approach’ directive that harmonized the regulation of medical devices and was adopted in the 1990’s. When the MDR was published, the European Commission announced that there would be a three-year transition period during which the MD directive and MDR would both be in place. During this time, manufacturers could choose to certify their products according to the old directive or the new MDR.
When the MDR was initially published, it was set to take full effect on May 26, 2020, at which time the medical device directive would be repealed, becoming obsolete. Because the MDR is different than the directive, any notified bodies that wish to continue to certify medium- and high-risk medical devices must apply for additional approval. However, in the last three years the competent authorities have had difficulties certifying enough notified bodies as it has taken more time than initially anticipated. Currently, there are only 20 notified bodies certified under the new MDR. For reference, under the medical device directive there were 60 approved notified bodies. This lack of notified bodies that are authorized to approve medical devices under the MDR has made it very difficult for manufacturers to get their devices recertified according to the new regulation.
The current COVID-19 pandemic has made it even more challenging for the competent authorities to address the issues surrounding the number of notified bodies, making it increasingly difficult for companies to get their products recertified by the May 26th deadline. As such, on April 3, 2020, the European Commission issued a proposal to the European Parliament and Council recommending a one-year delay of the MDR. The approval by the European Council and Parliament of this proposal was published in the Official Journal of the EU on April 24th, officially mandating that the medical device directive will remain in effect until May 26, 2021, at which time all medical device manufacturers in the EU will be required to have their device recertified in accordance with the MDR.
Usually this process takes about six months, but due to the timely nature of this specific proposal, it was rushed through the legislative procedures as quickly as possible.
From ventilators and respirators to all forms of personal protective equipment (PPE), it is no secret that medical devices have been a huge factor in treating and preventing the spread of COVID-19 during the current global pandemic. As such, regulatory agencies across the world have eased some of the regulations and red tape surrounding the approval of these products. The EU is no exception. In an attempt to increase the availability of these medical devices during the existing health crisis, Article 59 of the European Commission’s proposal states that any competent authority can place a non-CE marked medical device on the market within its territory in the interest of public health. This is the equivalent of the Emergency Use Authorization (EUA) in the United States.
In addition, the proposal also states that when this is done, member states should inform the European Commission, as the Commission can extend the national exception and make it applicable across the entire European Union for a limited amount of time.
Because this is very rarely used, there is currently no guidance regarding what needs to be submitted for compassionate use to be granted. Manufacturers need to show the authorities that the product in question is safe and that it performs the way it is supposed to. It will not be possible for manufacturers to provide all of the data that is required under the MD directive or the MDR, and the Commission understands that a limited data set will be submitted. In general, most manufacturers will probably be able to submit nonclinical data, including bench and performance testing, risk management data, and lab (i.e., animal) testing. However, because clinical data typically takes one to two years to collect and given that time is of the essence at this moment, most manufacturers’ submissions will be lacking this information at this point.
Although right now it may seem as though life is changed forever, we all know that at some point the pandemic will end and life as we knew it will return to normal. When that happens, any manufacturers whose device was granted compassionate use approval and placed on the market during this time will need to seek approval and obtain a formal compliance certificate from a notified body. We recommend doing this as quickly as possible and before the pandemic is officially over so that your product can stay on the market.
However, we are aware that seeking formal approval can be a challenging and daunting task. Furthermore, due to the lack of information and direction surrounding the compassionate use approvals in the EU, getting your device on the market right now may be a difficult and stressful situation. We are here to help you through this process, eliminating as much of your stress as possible. Our veteran team has extensive experience working with medical device manufacturers to get their products on the market in the EU.
To learn more about our services and how we can help you get your medical device on the market now and continue working with you to obtain a formal compliance certificate and ensure your product can stay on the market, contact us today.
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