August 24, 2020

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

Author: Suzanne Broussard

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.  

Overall, the consensus indicates that companies that that are able to comply with MDR should do so as fast as possible as discussed in more detail later in this piece.   

Medical device manufacturers need to quickly determine their need for audits and clinical trials as major considerations when making the decision on how to move forward. 

Audits by regulatory notified bodes are required for manufacturer that have not yet obtained MDR certification, and experts think there are many unknows for those with an MDR submission waiting for an audit. However, the legality of performing virtual audits is taking center stage. Manufacturers need to consider the following based on information as of July 2020:  

Physical Audits or Virtual Audits: 

  • Physical audits are currently not possible due to the COVID-19 pandemic
  • Virtual audits are allowed by the European Commission for some devices currently under the MDD, AIMDD, and In Vitro Device Directive (IVD), such as annual surveillance audits, recertification audits, or when change certification is needed or manufacturers must change notified bodies 
  • Virtual audits for MDD, AIMDD, and IVD are not authorized for the following: 
  1. Initial certification audits 
  2. Unannounced audits  
  3. Special audits that require on-site assessment (i.e., verification of the implementation of specific corrective actions, extend the scope of certification, etc.)  
  • Virtual audits are allowed for notified body renewal designations 
  • Physical audits are required for MDR initial certifications 
  • Virtual audits may be allowed for products already MDR certified 
  • For MDR, the virtual guidelines “may also apply to audits” if “the availability of devices is affected by COVID-19 restrictions.” It is unclear exactly what this means for manufacturers trying to obtain MDR certification. It appears as if the European Commission will not revise its rules anytime soon to allow for MDR remote audits under normal circumstances. Concessions maybe made on a case-by-case basis for devices considered “relevant to ensure medical care, especially if clinically necessary during the period of COVIC-19 restrictions.  

The current stance of physical audits for manufactures that are currently going through the MDR application or are in the process of submission are the most affected. Products ready to be audited against MDR may not be able to proceed. The industry is stressing the importance of virtual audits for MDR submissions, at least on an interim basis, as the requirement for physical audits will prevent MDR certifications requiring manufactures to rely on the directives. Manufacturers forced to reverse course and prepare for MDD or AIMDD will end up spending vast resources reworking technical documents to meet directives that could be better spend moving forward with the new regulation. 

Many believe that failure to allow virtual audits for MDR certification is penalizing the very manufacturers that hustled to meet the deadlines set out by the European Commission. This situation impacts manufacturers that have submitted the MDR and awaiting an audit.  

New medical device products may be stalled for the foreseeable future since notified bodies had already shifted gears to only audit new products under the new regulations. 

The potential implementation of new technologies like drones and google glasses along with webcam virtual tours are seen as ways to maintain the current high standards of audits. And, the use of these technologies can be modified to improve the task based on the vast experience obtained from the directives virtual audits.  

The number of notified bodies that are available to perform MDD audits is also of concern. Most notified bodies had shifted their focus to auditing MDR. A sift in manufactures focus from obtaining certification under MDR will also create a bigger bottleneck in 2024 when all devices must comply with MDR. 

Clinical Trials 

A recent publication in Nature Reviews: Drug Discovery highlights the challenges of drug development during a pandemic.1 A survey of 36 investigators that conduce clinical trials focused on cancer from around the world conducted by the Cancer Research Institute (CRI) and IQVIA indicates that the COVID-19 pandemic dramatically impacted clinical research. In the United States and Europe, on 14-20% of institutions are continuing to enroll patients at the usual rate. Those institutions that were continuing had lower enrollment rates and patient care was a key factor. The progress of clinical trials critical for all phases of regulatory compliance.  

The challenges of obtaining safety and performance data will certainly affect all aspects of medical device compliance. 

The decisions going forward is not easy choice and should be made based on where the company is in the process of preparing for MDR.  

Several high-profile organizations are weighing in on the dilemma. 

MedTech Insights recently hosted a panel discussion with 3 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. These experts agree that those that are in a position to move forward with MDR application should do so.2 They also stressed that “A year is not an extra year”.

MedTech Europe, an industry association, suggest that manufacturers that are not planning on MDR submission should consider using the MDD standards for now.3 MedTech went so far as to rank what it sees as the best 3 options according to perceived value: 

  1. State-of-the-art versions of standards that are harmonized under the current directives. 
  1. Other published standards identified as candidates for harmonization under the new regulations; or 
  1. Appropriate international and European consensus standards (ISO/IEC or EN), given that harmonized standards have mostly originated for them. 

MedTech Europe also indicated that manufacturers may need to use multiple standards to demonstrate state-of-the-art performance based on the specific requirements for each device. 

For those manufactures moving forward with preparing for the submission of MDR, the extra year to prepare provides some breathing room. Here are a number of areas that have increase requirements that manufactures can focus on to meet the significant challenges of MDR compliance.   

  • Quality management system 
  • Supply chain – new obligations 
  • Technical files – gaps, additional clinical data 
  • Post-market surveillance and vigilance systems 

The decision to move forward with either an MDR submission or shifting to obtain an early MDD certification and take advantage of the grace period until 2024 for MDR compliance is a big one for device manufacturers. It is critical to work with your notified body and regulatory experts to determine what path is right for you.   


Either way, Criterion Edge is prepared to provide expert medical writers to facilitate a timely submission.  

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August 18, 2020

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

Author: Suzanne Broussard

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.  

Software 

Software is a medical device according to the definition of IVD if that is its intended purpose; thus, software as part of an instrument, software as a medical device, and apps are included in the definition of IVDs and fall under IVDR regulation. This included genetic testing, companion diagnostics, as well as stand-alone software. 

software computer

At the Top of IVDR 2017/746, number 17 introduces software that falls under this regulation: 

(17) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic medical device, qualifies as an in vitro diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being purposes is not an in vitro diagnostic medical device. The qualification of software, either as a device or an accessory, is independent of the software’s location or the type of interconnection between the software and a device. 

To help medical software developers better understand the criteria “for the qualification of software falling within the scope of the new medical devices regulations,” the EU provided a guidance document on the application of the classification criteria for software. Follow the link below for The European Commission’s Medical Device Coordination Group (MDCG) 28-page guidance document released on October 11, 2019. 

Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR 

This guidance document clearly states in section 5.2 Classification Rules that the proper classification of medical device software requires the manufacturer to consider all classifications and implement the rules of Annex VIII of the IVDR.  

Here are the examples provided for the classification of medical device software: 

  • Software intended to be installed on a fully automated enzyme-linked immunosorbent assay (ELISA) analyser, and intended to determine the Human HbA1c concentration in serum from the results obtained with a Human HbA1c ELISA, intended to screen for and diagnose diabetes and monitor diabetic patients, should be in class C per Rule 3(k).  
  • Software within a PAP stain automated cervical cytology screening system, intended to classify the PAP cervical smear as either normal or suspicious, should be in class C per Rule 3(h).  
  • Software for the interpretation of automated readings of line immunoassay for the confirmation and determination of antibodies to HIV-1, HIV-1 group O and HIV-2 in human serum and plasma, should be in class D per Rule 1.  
  • Software that uses maternal parameters such as age, concentration of serum markers and information obtained through foetal ultrasound examination for evaluating the risk of trisomy 21, should be in class C per Rule 3(l). Classification examples in Annex IV are provided for guidance purposes and aim to illustrate how 

To fully see the magnitude of the inclusion of software as an IVD from a regulatory perspective we have created a table to highlights the regulations for software and provides a reference to the IVDR 2017/746 document. The list of requirements is extensive and includes general safety and performance requirements, technical documentation, registration of devices and economic operation, classification rules, and performance evaluation, performance studies and post-market performance follow-up. 

Title IVDR Reference Subject 
General Safety and Performance Requirements Annex I   
 Chapter 2 
     13.2 (d) 
Construction of devices and interaction with their environment 
      16  
     (16.116.4) 
Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves 
      20.4 (ah) Information in the instructions for use 
Technical Documentation Annex II  
      1.1 (k) Device description and specification 
      6.4 Software verification and validation 
Registration of Devices and Economic Operations Annex VI  
      PART C, 3.5 The UDI 
      6.2.1 UDI assignment criteria 
     6.2.3 Minor software revisions 
      6.2.4  
      (a-e) 
UDI placement criteria for software 
Classification Rules Annex VIII  
      1.4 Implementing rules 
Performance Evaluation Performance Studies and Post-Market Performance Follow-Up Annex XIII  
      Part A,  
      1.1  
Performance evaluation plan 
   

In summary, the regulation for all IVD devices changes with IVDR. The example above for software is just the tip of the iceberg. And, compliance with the new IVDR starts May 26, 2022. For more specific information on the time-line to transition to IVDR, classification of IVDs under IVDR, or analytical and clinical technical documentation aspects of IVDR conformity, check out our previous blog post. 


Feel free to contact Criterion Edge for more details on how we can help you successfully transition your in vitro device to the IVDR.

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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: Suzanne Broussard

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.  

The grace period for class I devices was incorporated to address the potentially very serious issue of lack of availability of CE-marked reusable instruments. However, the  Second Corrigendum contains more than just an extension of the transitional period for certain products in class I according to MDD, it also deals with data from the pre-and post-market phases of medical devices, and registration of products according to MDD and MDR. See the entire document for the details (English pg 43-49).  

In addition to providing some breathing room for manufacturers, this legally binding force takes some pressure off the few NBs currently designated under MDR to issue CE certificates as is required for all class I devices that up classify under the MDR.  

Manufacturers need to understand that most of the MDR requirements will still apply to the class I devices, and that the grace period is not a delay in the application of MDR. This means that manufacturers must still set up quality management systems and procedures for post-market surveillance (PMS)/ post-market clinical follow-up (PMSF) and procedures for clinical evaluation and risk management. 

Once the class I devices need to transfer to MDR CE certification, there will be more stringent requirements for clinical data. Fortunately, the extension when used effectively will provide manufacturers the clinical data needed to smoothly make the transition. The grace period essentially gives device manufacturers the opportunity to collect real-life data that can then be used as clinical evidence for the use of the device as they put in place the PMS, PMCF, and clinical evaluation.  

MDR Article 120.3 as it reads with Second Corrigendum  

By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives. 


It will still be challenging for device manufacturers to effectively organize and compile the technical documents required under MDR 2017/745. Criterion Edges offers a team of experienced medical writers that can assist your internal teams in any capacity, in preparing for the MDD to MDR transition. 

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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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