The IVDR implementation deadline is fast approaching, and many manufacturers are struggling to update systems and prepare compliant technical documentation. With client-validated IVDR transition processes, procedures, and tools, RQM+ can help you efficiently achieve compliance and add value to your business at the same time.

“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

How RQM+ Adds Value

  • Comprehensive Compliance Strategies

    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. 

    How important is it to work with an experienced consultancy company for IVDR file preparation? Listen to RQM+ Vice President of IVD Intelligence and Innovation answer.

  • Business-Balanced Solutions 

    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.

  • Industry Insights and Unrivaled Collective Knowledge

    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.  

    Hear RQM+ Vice President of IVD Intelligence and Innovation, Carlos Galamba, think back to his experience at BSI and comment on the state of manufacturers transitioning to the IVDR.


EU IVDR Timeline

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Click the plus sign within each date bubble to learn more.

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2017

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26 May

Entry Into Force

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.

 

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26 MAY 2017

Entry into Force

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.

July 2021

Title: Submission Start Date

Notified Bodies are no longer accepting new IVD Directive applications.

2022

Details
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26 May

Date of Application

All new IVDs placed on the EU market must comply with the new IVDR by this date in order to enter the EU market. IVDR PMS and vigilance procedures apply for all IVDs.

 

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26 MAY 2022

Date of Application

All new IVDs placed on the EU market must comply with the new IVDR by this date in order to enter the EU market. IVDR PMS and vigilance procedures apply for all IVDs.

Certificates issued under the IVDD before this date may remain valid until their expiration date or until 26 May 2025, 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.

A new amendment to the IVDR establishes a progressive rollout of Classes A sterile, B, C, and D for devices that were placed on the market before May 2022.

Class A devices (for example instruments) are not covered by the IVDR progressive roll-out amendment and must be IVDR certified by this date.

In-house manufactured devices can no longer be transferred to another legal entity.

2023

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26 May

PSURs Due

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.

 

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26 MAY 2023

PSURs Due

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.

Learn more about PSURs

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26 November

EUDAMED Registration

By this date, all devices must be registered in EUDAMED, the database developed by the European Commission to implement MDR and IVDR.

 

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26 NOV. 2023

EUDAMED Registration

By this date, all devices must be registered in EUDAMED, the database developed by the European Commission to implement MDR and IVDR.

2024

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26 May

Requirements for In-house Devices Apply

Under the new IVDR amendment, all in-house requirements must be met by health institutions as per Article 5 of the IVDR.

 

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26 MAY 2024

Requirements for In-house Devices Apply

Under the new IVDR amendment, all in-house requirements must be met by health institutions as per Article 5 of the IVDR.

Under the new IVDR amendment, the following requirements for in-house devices start applying:

  • Manufacturing occurs under a quality management system
  • The laboratory is EN ISO 15189 compliant
    Health institution draws up a declaration that the device meets the relevant GSPRs in Annex I
  • Technical documentation is required for class D in-house devices

The above is not an exhaustive list.

2025

Details
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26 May

End of Grace Period for IVDD CE Certificates

From this date onwards existing IVDD certificates are no longer valid.

 

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26 MAY 2025

End of Grace Period for IVDD CE Certificates

From this date onwards existing IVDD certificates are no longer valid.

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26 May

End of Transition for Class D

End of transition period for Class D devices that were placed on the market and had a signed declaration of conformity by 26 May, 2022.

 

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26 MAY 2025

End of Transition for Class D

End of transition period for Class D devices that were placed on the market and had a signed declaration of conformity by 26 May, 2022.

2026

Details
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26 May

End of Transition for Class C

End of transition period for Class C devices that were placed on the market and had a signed declaration of conformity by 26 May, 2022. This is also the end of the sell-off provisions for Class D (last service date).

 

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26 MAY 2026

End of Transition for Class C

End of transition period for Class C devices that were placed on the market and had a signed declaration of conformity by 26 May, 2022. This is also the end of the sell-off provisions for Class D (last service date).

2027

Details
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26 May

End of Transition for Class B and A Sterile

End of transition period for Class B and A sterile devices that were placed on the market and had a signed declaration of conformity by 26 May, 2022. This is also the end of the sell-off provisions for Class C (last service date).

 

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26 MAY 2027

End of Transition for Class B and A Sterile

End of transition period for Class B and A sterile devices that were placed on the market and had a signed declaration of conformity by 26 May, 2022. This is also the end of the sell-off provisions for Class C (last service date).

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26 May

No IVD Directive Products Placed on Market

All classes placed on the market must be in conformity with the IVDR by this stage.

 

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26 MAY 2027

No IVD Directive Products Placed on Market

All classes placed on the market must be in conformity with the IVDR by this stage.

2028

Details
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26 May

Last Service Date for Class B and A Sterile

This is the end of the sell-off provisions for Class B and A sterile.

 

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26 MAY 2028

Last Service Date for Class B and A Sterile

This is the end of the sell-off provisions for Class B and A sterile devices.

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26 May

Unmet Need Justification for In-house Devices

To continue using in-house devices, health institutions must justify in its documentation that the target patient group's specific needs cannot be met by equivalent CE marked devices on the market.

 

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26 MAY 2028

Unmet Need Justification for In-house Devices

To continue using in-house devices, health institutions must justify in its documentation that the target patient group's specific needs cannot be met by equivalent CE marked devices on the market.


When your team is overwhelmed with IVDR implementation, RQM+ is here to help.

As the date of IVDR application looms, many manufacturers are not sufficiently prepared, especially those that could previously self-certify under IVDD. From IVDR impact assessments to full program management and execution, our expert team can help you achieve compliance and keep your products on the market.

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NAVIGATE AND FILTER
THE IVDR AND MDR

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!
 

Explore IVDR ToolExplore MDR Tool

Tiger Team Approach

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.

Assessment

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.

Alignment

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. 

Gap Analysis

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. 

Planning

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. 

Execution

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. 

01 Expert Planning and Implementation

IVDR is new territory for a lot of manufacturers, but RQM+ has been involved from the beginning and understands the new requirements.

02 Best Practices and Case Studies

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. 

03 Client-Validated Processes

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. 

04 Former Notified Body Leadership

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. 


IVDR Implementation FAQs

What are the regulatory requirements for the intended purpose statement and why are companies struggling with compliance?

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.

As a manufacturer, why should we bother to figure out how the MDR and IVDR will be interpreted by the NB's? Why not just give our noncompliant documentation to the NB, let them tell us what's wrong and then we'll do it?

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.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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