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.  

The European Commission provided guidelines in September of 2019 on the presentation, content, and validation of the SSCP to fulfill the objectives of MDR in MDGC 2019-9. That guidance document can be accessed here. 

Since the EUDAMED’s live rollout has been officially delayed by 2 years, intended users and manufacturers will have to wait until May 26, 2022 to access the treasure trove of data.  

Including the SSCP into the MDR 2017/745 was primarily intended to provide healthcare providers with current data to allow them to make informed decisions for patient treatment options. However, this level of transparency has the potential to change the playing field for medical device manufacturers in unforeseen ways. 

With healthcare professionals and competitors looking at your organizations SSCP, it is important that they are not only technically correct but also polished. This may be challenging for many manufacturers to get the technical documents up to speed, even with the possible 1-year MDR extension*.

* MDR deadline has been extended one year to May 26th, 2021


If you would like some guidance with the SSCP, PMCF, CER, or other technical documents, please reach out to our experts at Criterion Edge.

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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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[WEBINAR] Live Q+A for ‘Assess Your CER for MDR Readiness, Part 1’ with Laurie

We had a large turnout at our webinar on April 29, 2020, “How to Assess Your CER for MDR Readiness, Part 1 : State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review.” We ended with many unanswered questions. To answer these and more questions, President Laurie Mitchell is coming back to host a Question & Answer session LIVE.

Jun 4, 2020 11:00 AM in Pacific Time (US and Canada)

Click here to register for this free webinar