“We are very pleased with the IVDR risk management remediation work that has been provided by your team and we appreciate the support!”
- RQM+ IVDR Implementation Project for a Global Medical Device and Diagnostics Manufacturer
Transitioning to a new regulatory paradigm is an opportunity to shift away from a risk-based necessity to value-driven solutions. RQM+ helps IVD manufacturers do this with transformative solutions that integrate systems and add efficiencies to improve the business as a whole.
No matter how large or small the scope of the project, we act as a strategic partner that understands and prioritizes your business goals. Whether we are helping with portfolio planning, project management, or task execution, RQM+ always provides risk-balanced solutions that make sense for your business.
With former notified body leadership on staff, we know what reviewers expect from your technical documentation, allowing us to deliver right-sized solutions for compliance. When we learn something new, it gets integrated into our learning system to grow the unrivaled collective knowledge you won’t find in other consulting firms.
The EU IVDR was published in the Official Journal of the European Union on 5 May 2017, and entered into force on 26 May 2017.
Title: Submission Start Date
Notified bodies are requesting submissions by July 2021 in order to issue certificates by the date of application.
All IVDs and related procedures, systems, and documentation must comply with the new IVDR by this date in order to enter the EU market. Certificates issued under the IVDD before this date may remain valid until their expiration date or until 26 May 2024, whichever comes first. The validity of the IVDD certificates after the date of application is conditional on compliance with the provisions described in Article 110, clause 3. If you make a significant change to your IVD certified device, you will be required to obtain IVDR certification.
If you have a self-declared IVD per your Declaration of Conformity (DoC), that does not count as an IVD certificate and you must comply with the IVDR on this date.
All devices, whether IVDD or IVDR certified, must have IVDR PMS, Vigilance, and Market Surveillance on the date of application. Registration via ACTOR module of EUDAMED strongly encouraged.
By this date, all devices must be registered in EUDAMED, the database developed by the European Commission to implement MDR and IVDR.
Class C and D in vitro diagnostic devices are required to submit annual periodic safety update reports (PSURs), which will be due one year after the date of application.
Any unexpired notified body certificates issued under IVDD will become void on this date. All devices placed on the market must conform with EU IVDR.
Sell-through provision starts for IVDD devices already on the market. This means if you have products in your warehouse in an EU country, you can continue to sell these products for one additional year.
Class A and B devices should have their first post-market surveillance report ready for review.
This is the last possible date to put IVDD devices into service that were already on the market. This means you can no longer sell IVDD product from your warehouse.
Our new series of interactive tools allow you to easily filter lines of the IVDR and MDR by topic, chapter, section, article, and any search term. Many of our experts have this tool open at all times on their computers for quick access and it's been a game changer. Now we're sharing them with you!
We will provide a dedicated team that is laser-focused on transitioning your products, systems, and processes to comply with IVDR while staying in alignment with your business goals. We have expert resources across all workstreams who ensure deadlines are met so your team can continue to focus on daily operations.
We perform an IVDR impact assessment that provides input to a comprehensive transition plan and eliminates surprises. The assessment includes a high-level examination of all IVDR requirements that will have a significant impact on your business, including notified body engagement, classification assessment, QMS impact, technical file expectations (including risk management), PERs, economic operators, labeling (including UDI and translations), and post-market surveillance.
Based on the results of your impact assessment, we will deliver client-specific training programs, including executive-level training and tactical training for all levels. We'll develop a preliminary plan including a definition of workstreams, team assignments, governance processes, schedule, and budget. We will provide an assessment of your product portfolio plan that aligns product lifecycle management, regulatory requirements, remediation costs, and your business goals.
We will use our validated, automated tools to conduct an efficient gap assessment of every regulatory file until we identify consistent themes that enable remediation planning. This encompasses all elements of IVDR—general safety and performance requirements (GSPR), labeling, technical documentation, performance evaluation reports (PERs), and post-market surveillance (PMS)—including existing IVD compliance issues that will no longer pass a notified body review.
We will use our proven project management tools to develop and finalize program and remediation plans, monitor and report progress for all workstreams, and continually update risks and mitigations. With industry-leading subject matter expert advisors on call at RQM+, we can tackle any challenge for any IVD and create a plan that guides you through any necessary remediation activities.
Whether you need targeted support for discrete tasks, fully managed services, or an IVDR expert on call, we have you covered. Depending on your specific needs, we provide regulatory leadership and support, project management, gap assessments, SME support for all functions, risk management file creation/remediation, standards compliance strategies, supplier quality, performance evaluations, labeling, revisions, quality system updates, and post-market surveillance services.
You need more than added capacity for IVDR implementation. You need expert support from a team that has done it before. That is exactly what you get with RQM+: experience, expertise, thought leadership, and unique industry insights.
IVDR is new territory for a lot of manufacturers, but RQM+ has been involved from the beginning and understands the new requirements.
We regularly interact with and gather feedback from notified bodies, including BSI, TÜV SÜD, and GMED. From this, we develop best practices for all aspects of IVDR implementation.
We update and improve our processes with every project. With hundreds of technical documentation files under our belts, our client-validated processes enable efficiency and accuracy.
We know what reviewers want to see because RQM+ leadership and staff include people who have participated on committees, drafted MDCG guidance documents, created IVDR interpretation, and trained notified body teams.
It’s really easy to go a little off the rails. I could say my intended purpose is I’m going to measure this enzyme because it is an indicator of inflammation. That sounds all well and good, and then all of a sudden you start to publish information and you start to advertise in cardiology journals and you start to put some things out there. Now all of a sudden your intended purpose has gone from: I’m measuring this enzyme to I’m going to predict whether you’re going to have a heart attack in the next five years. And the data and everything you need around that changes when you change that intended purpose.
The NBs are now limited in the number of rounds of questions, so essentially if you do that you are wasting one round of questions. And then when you provide the information that they want, and you’re going to get more questions, so the possibility of failure is much greater. There is also pre-submission checks now, so they’re going to do a sanity check that is a bit more intense than it has been in the past, so chances are it might even get rejected at that sanity check stage.
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