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 26^th, 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.  

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.  

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.  

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 4–year (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.