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With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products, however many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR), screening, selection and data extraction.
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
Key Takeaways:
• Review the essential steps for conducting a robust, methodologically-sound systematic literature review
• Using a typical case study scenario, learn how to effectively search, identify, screen, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
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Author: Suzanne Broussard
The newly created Person Responsible for Regulatory Compliance (PRRC) position is a unique regulatory requirement that applies only to the European Union, and is a key area of responsibility for a person or persons under the Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR).
The motivation for creating the PRRC positions is so that there is a qualified regulatory expert directly responsible for the manufacturing and the market surveillance and reporting systems to ensure the company is meeting the European Union requirements.
The Regulations have a clear desire to add an additional level of scrutiny to the supervision and control of the manufacturing of medical devices, as well as relevant post-market surveillance and vigilance activities. Thus, the PRRC role is purposefully a unique position from the European Union Authorized Representative.
The requirements, qualifications, and responsibilities of the PRRC is outline in Article 15 of both Regulation (EU) 2017/745 MDR and Regulation (EU) 2017/746 (IVDR).
Article 15 of both MDR and IVDR state:
“Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.”
Manufacturers will be looking closely at how to fill these positions. Parent companies with more than one legal manufacturer under the organization needs to ensure that each legal manufacturer has its own PRRC. Micro or small business enterprises have the option to contract a PRRC (EU definition of micro and small businesses can be found in Regulation 2003/361/1C).
Responsibilities
The PRRC has at least 5 responsibilities clearly outline in Article 15.
Guidance Document
The Medical Device Coordination Group (MDCG) released a guidance document on 20 June 2020 addressing some of the questions about the person responsible.
Medical Devices: Guidance document
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC)
The guidance clarifies the training and/or professional experience necessary to hold the position of PRRC. The qualifications for this role can be met with either education (certification/diploma) or experience. The PRRC does not have to perform all these duties themselves but is responsible for their completion.
TEAM-PRRC
To support those with the role of PRRC, a new not-for-profit European associating has been launched – TEAM-PRRC. The association represents it members at the highest level – the European Commission and Medical Device Coordination group (MDCG). TEAM-PRRC plans to provide the framework and rigorous analysis required to gain insight and influence the guidance that is being developed for the PRRC role. TEAM-PRRC aims to:
The newly created role of PRRC will bring many challenges for manufacturers and regulatory specialist, and there is a lot at stake for those considering taking this role. The regulations mandate penalties that are decided on the level of the member states for noncompliance and individuals taking this role need to be aware of the potential consequences.
Criterion Edge is dedicated to providing support for medical device and pharmaceutical manufacturers, and we do this in part by keeping device manufacturers up to date on current events. For more information on the new MDR guidance documents, extension, and grace period, see our previous posts.
Either way, Criterion Edge is prepared to provide expert medical writers to facilitate a timely submission.
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:
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:
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.
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.
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.
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.
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:
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.
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.
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:
Devices that are not eligible for the grace period:
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.
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
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