July 20, 2020

[FEATURED] FDA To Makers Of EUA Devices: Don’t Forget To Report Adverse Events

Manufacturers of devices granted emergency use authorization (EUA) status during the COVID-19 crisis are fully responsible for filing any adverse events about the products to the FDA, the US agency says on a new FAQ page.

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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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May 20, 2020

[FEATURED] EU COVID-19 Response: Who Is Leading EU’s Decision-Making For Medtech?

The COVID-19 pandemic has meant seismic shifts in the way the EU has been operating to regulate and procure emergency equipment needed on the frontline. Unprecedented changes have been required, but how did the EU achieve this so quickly and how has its reaction impacted central decision-making and how member states work together?

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May 11, 2020

The Summary of Safety and Clinical Performance (SSCP) Provides Valuable Information to Health Care Providers, Patients, and Manufacturers

Author: Suzanne Broussard

Medical report checkoff

Is your organization ready to display to the world your medical devices safety and performance record? The Summary of Safety and Clinical Performance (SSCP) is one of the new requirements imposed by manufacturers by the European Commission in Medical Device Regulations (MDR)2017/745 for implantable devices and class III devices. And, SSPC will go virtual when EUDAMED roles out in 2022. 

The SSCP is intended to provide intended users (healthcare professionals, and if relevant patients) with an updated summary of the device’s safety, clinical data, and clinical performance. This enhanced transparency provides everyone with adequate access to the devices clinical data, including your customers and your competitors.  

The SSCP should be sourced directly from the technical documentation, including the clinical evaluation report (CER), post-market surveillance, and post-market clinical follow-up (PMCF). And, the SSCP “shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (EUDAMED).” The SSCP must be updated at least annually. 

There are added benefits to making the SSCP public knowledge that can benefit manufacturers. Organizations can utilize the public information to their advantage. For example, manufacturers can use competitors SSCPs to:  

  • Justify their devices proposed pre-market and post-market studies 
  • Understand other devices strengths and weaknesses to improve your device 
  • Justify risk  
  • Increase market awareness 

Deadlines Extended to Allow Citizens Time to Safely Respond to the COVID-19 pandemic. 

The European Commission has proposed to extend the deadline for MDR compliance by one year (at this time waiting for approval by member states and publication in the Official Journal). The launch of EUDAMED has also been delayed. Now, EUDAMED will be launched together with the in-vitro medical devices in May 2022. 

The SSCP is still required to be part of MDR 2017/745 even though the launch of EUMADED has been moved back. 

A silver lining to the current health crises is that medical device manufacturers now have more time to become fully compliant with the European Commission regulations.  

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March 18, 2020

[FEATURED] EU’s IVDR Could Spell Disaster In Halting Spread Of Next COVID-19-Type Virus

The spread of COVID-19 has been slowed in many places through widespread testing of infected patients’ contacts. But the EU IVDR could mean the end of such early preventive action and much more rapid spread of such infections in future, unless action is taken now to amend the regulation.

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