August 24, 2020

MDD or MDR? Medical Device Manufacturers Are Faced with a Big Decision Going Forward Under the MDR Extension

Author: Suzanne Broussard  | August 24, 2020

The passing of the delay for the Medical Device Regulation (MDR) date of application to May 26, 2021 was welcoming news for many device manufacturers. However, the delay now has manufacturers close to MDR submission questioning what the best course of action is now that they have a choice. Should they continue to push for certification under MDR 2017/745, or should they backtrack to Medical Device Directive (MDD) certification? 

The amended regulation to extend the MDR date of application by 1 year was needed due to the immense burden placed on the healthcare industry by the global COVID-19 pandemic. The pandemic immediately increased demand for personnel protective gear, such as medical gloves, surgical masks, and the equipment required to treat patients infected with COVID-19. The extension for the MDR date of application was implemented to prevent shortages of the needed medical devices that were previously certified under the MDD or Active Implantable Medical Device Directive (AIMDD) but have not yet obtained certification under MDR.  

In addition to the direct burden on the healthcare industry, the pandemic significantly impacted the medtech industry by significantly  restricting the ability of medical device manufacturers to meet the original May 26th, 2020 deadline due to social distancing and travel restrictions. Once this became evident, the European Commission and Member States acted quickly to pass the amended regulation that pushed the date of application for MDR to 26 May 2021 and allows MDD and AIMDD to apply until this date.  

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August 18, 2020

Software Can Be An In Vitro Diagnostic Device Under IVDR 2017/746

Author: Dr. Suzanne Broussard  | August 18, 2020

Software is now considered a medical device if that is its intended purpose according to the European Union’s definition of in vitro diagnostic (IVD) devices in the new In Vitro Diagnostic Regulation (IVDR) 2017/746.  

Here we look at the scope of how this change in definition impacts software developers within the IVD space, and we use this as an example of the magnitude of the new IVDR regulation for all IVDs.  

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August 10, 2020

The Second Corrigendum of Medical Device Regulation (MDR) 2017/745 Offers Manufacturers a 4-Year the Grace Period for Eligible Class I Medical Devices

Author: Dr. Suzanne Broussard  | August 10, 2020

The European Parliament adopted a Second Corrigendum of MDR 2017/745 to address the serious possibility for shortages of reusable class I medical devices under the newest Medical Devices Regulation (MDR) 2017/745.  

balancing time

The Second Corrigendum has significant scope changes that benefit class I devices falling under the up classification of the MDR 2017/745 rules. This is significant because as much as 80% of devices designated as class I under MDD will be “up classified,” e.g., moved from class I to a class II or even a class III designation, under MDR, and therefore face major hurdles and Notified Body (NB) approval to be marketed in the European Union. Thus, understanding and maintaining compliance under these dynamic regulations can be quite a balancing act.  

Under the MDR, some class I devices are given a grace period until 26 May 2024 to be fully compliant. Article 120 section 3 of the Second Corrigenda clarifies which class I devices can benefit from the grace period. 

Class I Devices eligible for the 4year (now 3-year) grace period: 

  • Class I reusable surgical devices  
  • Many substance-based devices 
  • Software that will be up classified  

Devices that are not eligible for the grace period: 

  • Devices that are class I self-certified under MDD at the time of MDR application  
  • Class I devices that are not up classified and will not need a NB  
  • Class I devices that have significant changes made in the design or intended use under the MDD certification once MDR is full force. 
  • Any new class I devices that manufacturers develop and place on the market after 25 May 2021. 

NBs and manufacturers have been working overtime to get as many class I devices into the grace periods as possible. Manufacturers able to obtain MDD certification by the MDR date of application will have the significant benefit of the grace period to become compliant with MDR. The original MDR date of application provides a 4-year grace period. However, the 26 May 2020 deadline has been extended to 26 May 2021 due to the global COVID-19 pandemic. The deadline for class I device to be MDR compliant remains 26 May 2024, leaving manufacturers a 3-year grace period. Indeed, the recent 1-year extension for compliance with MDR 2017/745 will likely be used the most by manufacturers pushing to get their class I devices certified under MDD, and to ensure that the self-certification class I devices meet the MDR requirements.  

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June 23, 2020

The Deadline for Compliance with MDR 2017/745 is Extended to 26 May 2021: Changing and Challenging Dynamics

Author: Suzanne Broussard

The global COVID-19 pandemic prompted the 1-year extension of the Medical Device Regulation (MDR) 2017-745 date of application. The delay is creating a changing and challenging dynamic landscape for device manufacturers and notified bodies (NBs). 

As the seriousness of the COVID-19 pandemic emerged in March, the European Commission recommended a 1-year extension to the MDR date of applicability, the Parliament and Council then acted quickly with an almost unanimous decision supporting the delay, and the extension was ultimately accepted by the member states and published in the Official Journal on 23 April 2020. 

The ongoing pandemic has created a high demand for resources such as surgical masks, medical gloves, and other medical and personnel protective equipment — keep these supplies flowing is a top priority to protect both patients and healthcare workers. The delay of the MDR date of applicability was implemented to ensure that hospitals and healthcare facilities have a continued supply of devices during the critical times of the pandemic.  

It is important moving forward to understand that the delay was not implemented to provide manufacturers with more time to become compliant with MDR, and the European Commission expects that manufactures are continuing to work to comply with the newest regulation. However, the delay presents both opportunities and challenges for manufacturers. 

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