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. 

Opportunities 

Of course, the biggest benefit of the delay is time. Time that is in short supply for manufacturers and NB dealing with the ongoing changes to device regulations. The extra time may most benefit manufacturers of class I devices that were short on time to take advantage of the grace period provided under the second corrigendum of MDR 2017/45.  Manufacturers in the following positions have the most to gain by the 1-year delay. 

  • Class I Devices with Significant Changes: The Second Corrigendum of MDR 2017/745 provides a grace period for some self-declared class I devices under MDD. The grace period essentially means that qualifying class I devices do not need to be certified to the new MDR regulation but instead can utilize the MDD Declaration of Conformity until the 25th of May 2024. However, the class I device cannot have significant changes. The additional time may allow manufacturers of class I devices that are likely to be up classified under MDR and have not already done so the time to make the necessary revisions and complete an MDD CE certification. 
  • Renewal of MDD Certification: Device manufactures that needed a little more time to renew their Medical Device Directive (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) CE-certification now have some breathing room. The impact on manufacturers that may have just missed the original deadline for the MDR date of application is immense since devices with a current certification under MDD are allowed to utilize the transition period covered in MDR 2017/745 giving 3 more years to become fully complaint in 26 May 2024. 
  • Compliance with Post-Market Surveillance, Market Surveillance, Vigilance, and Registration of Economic Operators:  This is an important area for manufacturers since they must still set-up and maintain a number of systems for the application of MDR. Manufacturers need to develop and implement quality management systems and procedures for risk management, clinical evaluation, and post-marketing surveillance (PMS) / post-market clinical-follow-up (PMCF). These processes take time to develop and improve. Likewise, logistic issues like Economic Operator requirements and contracts can be evaluated.   
  • Notified Bodies: The European Commission and EU Member States will have an additional year to accredit NBs under the MDR. The number of NBs is still far fewer than the original projections, and these NBs are overextended working with manufacturers that are scrambling under these tight deadlines to obtain an early MDD to take advantage of MDR’s transitional provisions.  

The delay is also creating several challenges for both manufacturers and NBs. 

Challenges 

Medtech Insight hosted an MDR discussion panel consisting of 3 outspoken and renowned experts on the regulations of medical devices in the European Union: Bassil Akra  of  QUNIQUE consultancy (formally of TÜV-SÜD notified body), Gert Bos of Qserve consultancy, and Erik Vollebregt of Axon Lawyers.1 

The take home message from this highly respected panel was simple. 

A year is not an extra year. 

Several important considerations were raised in the panel discussion that device manufacturers should take into consideration. 

  • NBs are working very hard to get class I devices that are eligible into the grace period provided by the Second Compendium published as recently as 25 November 2019. In order to take advantage of the grace period, the current MDD certification has to be renewed by the date of MDR application (now the extended 26 May 2021 date). This is a real hurdle because many class I device manufacturers have not used NBs in the past, and therefore many of these manufacturers really need the delay to adequately prepare 
  • The large medical device manufacturers are accustomed to working in this regulatory space, but many of the smaller distributors and third-party logistics (3PL) companies still have a fair amount of confusion and it takes time for all the news to trickle through the pipeline. 
  • Only a handful of NBs (2) are currently focused on new MDRs, most of the 14 NBs are focused on renewals and may not have enough time or resources to transition from MDD to MDRs. 
  • There has been a flurry of guidance documents published in May, giving manufacturers little time to react to the interpretations. NBs and manufacturers are hoping for a more relaxed interpretation of the guidance documents, but there is no guarantee the member states will have consistent implementation. 

The panelists agree there is much to do moving forward.   

The additional challenges of social distancing and the general global lockdown brought on by the pandemic will impact the ability of NBs and manufacturers moving forward. A recent ruling allowing NBs to conduct virtual audits for MDD renewal was critical. However, delays will make the new extension seem like much less than a year. 

1. EU MDR Panel Discussion: Why An Extra Year Is Not Really A Delay For The MDR – How To Survive Changing And Confusing Times. Medtech Insight https://medtech.pharmaintelligence.informa.com/MT142211/EU-MDR-Panel-Discus 


Reach out to Criterion Edge for support getting your technical documents ready for MDD renewal or the MDD to MDR transition. We have expert medical writers to support your organizations in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today. 

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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.  

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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